CANVAS - CANagliflozin cardioVascular Assessment Study
Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT01032629
Collaborator
The George Institute for Global Health, Australia (Other)
4,330
313
3
86.5
13.8
0.2
Study Details
Study Description
Brief Summary
The study will assess canagliflozin (JNJ-28431754) in the treatment of patients with type 2 diabetes mellitus (T2DM) with regard to cardiovascular (CV) risk for major adverse cardiac events (MACE). Other objectives include evaluating the overall safety, tolerability, and effectiveness of canagliflozin.
The data from this study will be combined with the data from CANVAS-R study (Study of the Effects of Canagliflozin on Renal Endpoints in Adult Subjects with T2DM, NCT01989754) in a pre-specified integrated analysis of CV safety outcomes to satisfy US FDA post-marketing requirements for canagliflozin.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
The study will evaluate canagliflozin compared to placebo on CV events including CV death, heart attack, and stroke in patients with T2DM, whose diabetes is not well controlled at the beginning of the study and who have a history of CV events or have a high risk for CV events. The study includes 3 substudies which will compare the effectiveness of lowering blood glucose and assess the safety of canagliflozin relative to placebo in patients receiving specific commonly-used diabetes agents. 4,330 participants will be randomly assigned to treatment with 1 of 2 doses of canagliflozin (100 or 300 mg) or placebo, in a 1:1:1 ratio. This study was originally designed to last for up to 9 years. As per FDA post-marketing requirements for canagliflozin, the study's last subject last visit will now occur when enough MACE events (ie, CV death, nonfatal myocardial infarction, nonfatal stroke) are accumulated between the CANVAS (this study) and CANVAS-R studies. The completion target was reached in February 2017.
Study Design
Study Type:
Interventional
Actual Enrollment
:
4330 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of JNJ-28431754 on Cardiovascular Outcomes in Adult Subjects With Type 2 Diabetes Mellitus
Actual Study Start Date
:
Dec 9, 2009
Actual Primary Completion Date
:
Feb 22, 2017
Actual Study Completion Date
:
Feb 22, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo Each patient will receive placebo (inactive medication) on background standard of care for diabetes once daily for the duration of the study |
Drug: Placebo
One placebo capsule taken orally (by mouth) once daily
|
| Experimental: Canagliflozin (JNJ-28431754) 100 mg Each patient will receive canagliflozin (JNJ-28431754) 100 mg once daily on background standard of care for diabetes once daily for the duration of the study |
Drug: Canagliflozin (JNJ-28431754) 100 mg
One 100 mg capsule taken orally (by mouth) once daily
|
| Experimental: Canagliflozin (JNJ-28431754) 300 mg Each patient will receive canagliflozin (JNJ-28431754) 300 mg once daily on background standard of care for diabetes once daily for the duration of the study |
Drug: Canagliflozin (JNJ-28431754) 300 mg
One 300 mg capsule taken orally (by mouth) once daily
|
Outcome Measures
Primary Outcome Measures
- Major Adverse Cardiovascular Events (MACE) Composite of Cardiovascular (CV) Death, Non-Fatal Myocardial Infarction (MI), and Non-Fatal Stroke [Up to approximately 8 years]
MACE, defined as a composite of CV death, non-fatal MI, and nonfatal stroke. Adjudication of these events by the Endpoint Adjudication Committee (EAC) was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of MACE are presented.
Secondary Outcome Measures
- Change From Baseline in Homeostasis Model Assessment 2 Steady-State Beta-Cell Function (HOMA2-%B) at the End-of-Treatment (EOT) [Baseline and end of treatment (approximately 338 weeks)]
The homeostatic model assessment (HOMA) quantifies insulin resistance and beta-cell function. HOMA2-%B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady-state beta cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100 percent.
- Percentage of Participants With Progression of Albuminuria at the End-of-Treatment [End of treatment (approximately 338 weeks)]
Progression defined as the development of micro-albuminuria (albumin/creatinine ratio (ACR) greater than or equal to [>=] 30 milligram per gram (mg/g) and less than or equal to <= 300 mg/g) or macroalbuminuria (ACR of >300 mg/g) in a participant with baseline normoalbuminuria or the development of macro-albuminuria in a participant with baseline microalbuminuria. Percentage of participants with progression of albuminuria at the end-of-treatment were assessed.
- Change From Baseline in Proinsulin/Insulin (PI/I) Ratio at the End-of-Treatment [Baseline and end of treatment (approximately 338 weeks)]
A raised proinsulin-to-insulin ratio due to impaired processing of proinsulin is an early marker of beta cell dysfunction. Beta-cell dysfunction was evaluated by calculating the PI/I ratio, which estimates the capacity of beta cells to convert proinsulin to insulin and may represent an acceptable method to indicate the degree of beta-cell secretion.
- Change From Baseline in Urinary Albumin/Creatinine Ratio at End-of-Treatment [Baseline and End of treatment (approximately 338 weeks)]
Urinary Albumin/Creatinine Ratio is a potential marker of chronic kidney disease, calculated as a ratio of Urinary Albumin and Urinary Creatinine.
- Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at End-of-Treatment [Baseline and end of treatment (approximately 338 weeks)]
Change from baseline in Estimated Glomerular Filtration Rate (eGFR) was assessed at end of treatment. GFR is a measure of the rate at which blood is filtered by the kidney. Modification of Diet in Renal Disease (MDRD) is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and sex. eGFR milliliters/minute/1.73 meters square (mL/min/1.73 m^2) = 175 * (serum creatinine) ^ 1.154 * (Age) ^-0.203 *(0.742 if female) * (1.21 if Black).
- Change From Baseline in Glycated Hemoglobin (HbA1c) at End-of-Treatment [Baseline and end of treatment (approximately 338 weeks)]
Change from baseline in glycated hemoglobin (HbA1c) percentage (%) was assessed at end of treatment. Glycated hemoglobin is a form of hemoglobin that is measured primarily to identify the average glucose concentration in the blood.
- Change From Baseline in Fasting Plasma Glucose (FPG) Levels at End-of-Treatment [Baseline and end of treatment (approximately 338 weeks)]
Change from baseline in the fasting plasma glucose levels at end-of-treatment was assessed.
- Percent Change From Baseline in Body Weight at End-of-Treatment [Baseline and end of treatment (approximately 338 weeks)]
Percent change from baseline in body weight was assessed at the end of treatment.
- Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at End-of-Treatment [Baseline and end of treatment (approximately 338 weeks)]
Change from baseline in systolic blood pressure and diastolic blood pressure was assessed.
- Change From Baseline in Triglycerides Levels at End-of-Treatment [Baseline and end of treatment (approximately 338 weeks)]
Change from baseline in triglycerides levels was assessed.
- Change From Baseline in Cholesterol, High-Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) Levels at End-of-Treatment [Baseline and end of treatment (approximately 338 weeks)]
Change from baseline in cholesterol, high-density lipoprotein cholesterol and low density lipoprotein cholesterol levels were assessed.
- Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) to High-Density Lipoprotein-Cholesterol (HDL-C) Ratio at End-of-Treatment [Baseline and end of treatment (approximately 338 weeks)]
Change from baseline in LDL-C to HDL-C ratio was assessed.
Eligibility Criteria
Criteria
Ages Eligible for Study:
30 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Patients must have a diagnosis of type 2 diabetes mellitus and greater than or equal to (>=) 30 yrs old with history of cardiovascular (CV) event, or >= 50 yrs old with high risk of CV events
-
Patients must have inadequate diabetes control (as defined by glycosylated hemoglobin greater than or equal to 7.0% to less than or equal to 10.5% at screening) and be either (1) not currently on diabetes drug therapy or (2) on therapy with any approved class of diabetes drugs
Exclusion Criteria:
-
A history of diabetic ketoacidosis, type 1 diabetes mellitus, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
-
History of one or more severe hypoglycemic (ie, very low blood sugar) episode within 6 months before screening
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Birmingham | Alabama | United States | ||
| 2 | Mesa | Arizona | United States | ||
| 3 | Tucson | Arizona | United States | ||
| 4 | La Mesa | California | United States | ||
| 5 | Los Gatos | California | United States | ||
| 6 | Pismo Beach | California | United States | ||
| 7 | Stockton | California | United States | ||
| 8 | Walnut Creek | California | United States | ||
| 9 | Doral | Florida | United States | ||
| 10 | Fort Lauderdale | Florida | United States | ||
| 11 | Jacksonville | Florida | United States | ||
| 12 | Miami | Florida | United States | ||
| 13 | Plantation | Florida | United States | ||
| 14 | Atlanta | Georgia | United States | ||
| 15 | Duluth | Georgia | United States | ||
| 16 | Boise | Idaho | United States | ||
| 17 | Eagle | Idaho | United States | ||
| 18 | Meridian | Idaho | United States | ||
| 19 | Peoria | Illinois | United States | ||
| 20 | Topeka | Kansas | United States | ||
| 21 | Crestview Hills | Kentucky | United States | ||
| 22 | Lexington | Kentucky | United States | ||
| 23 | Auburn | Maine | United States | ||
| 24 | Scarborough | Maine | United States | ||
| 25 | Oxon Hill | Maryland | United States | ||
| 26 | Royal Oak | Michigan | United States | ||
| 27 | Kansas City | Missouri | United States | ||
| 28 | Saint Louis | Missouri | United States | ||
| 29 | Omaha | Nebraska | United States | ||
| 30 | Camden | New Jersey | United States | ||
| 31 | Bronx | New York | United States | ||
| 32 | Flushing | New York | United States | ||
| 33 | Chapel Hill | North Carolina | United States | ||
| 34 | Charlotte | North Carolina | United States | ||
| 35 | Cincinnati | Ohio | United States | ||
| 36 | Cleveland | Ohio | United States | ||
| 37 | Columbus | Ohio | United States | ||
| 38 | Gallipolis | Ohio | United States | ||
| 39 | Mentor | Ohio | United States | ||
| 40 | Toledo | Ohio | United States | ||
| 41 | Beaver | Pennsylvania | United States | ||
| 42 | Norristown | Pennsylvania | United States | ||
| 43 | Sayre | Pennsylvania | United States | ||
| 44 | Greenville | South Carolina | United States | ||
| 45 | Kingsport | Tennessee | United States | ||
| 46 | Dallas | Texas | United States | ||
| 47 | Houston | Texas | United States | ||
| 48 | Odessa | Texas | United States | ||
| 49 | San Antonio | Texas | United States | ||
| 50 | Temple | Texas | United States | ||
| 51 | Draper | Utah | United States | ||
| 52 | Salt Lake City | Utah | United States | ||
| 53 | Sandy | Utah | United States | ||
| 54 | West Jordan | Utah | United States | ||
| 55 | Danville | Virginia | United States | ||
| 56 | Richmond | Virginia | United States | ||
| 57 | Spokane | Washington | United States | ||
| 58 | Tacoma | Washington | United States | ||
| 59 | Buenos Aires | Argentina | |||
| 60 | Capital Federal | Argentina | |||
| 61 | Ciudad Autonma Buenos Aires | Argentina | |||
| 62 | Ciudad Autonoma De Buenos Aires | Argentina | |||
| 63 | Cordoba | Argentina | |||
| 64 | Corrientes | Argentina | |||
| 65 | Godoy Cruz | Argentina | |||
| 66 | Mar Del Plata | Argentina | |||
| 67 | Rosario | Argentina | |||
| 68 | Santa Fe | Argentina | |||
| 69 | Auchenflower | Australia | |||
| 70 | Box Hill | Australia | |||
| 71 | Caboolture | Australia | |||
| 72 | Caringbah | Australia | |||
| 73 | Clayton | Australia | |||
| 74 | Daw Park | Australia | |||
| 75 | East Ringwood | Australia | |||
| 76 | Elizabeth Vale | Australia | |||
| 77 | Hornsby, Nsw 2077 | Australia | |||
| 78 | Kippa Ring | Australia | |||
| 79 | Launceston | Australia | |||
| 80 | Liverpool | Australia | |||
| 81 | Melbourne | Australia | |||
| 82 | Milton | Australia | |||
| 83 | Parkville | Australia | |||
| 84 | Reservoir | Australia | |||
| 85 | Sherwood | Australia | |||
| 86 | Southport | Australia | |||
| 87 | St Leonards | Australia | |||
| 88 | West Heidelberg | Australia | |||
| 89 | Wollongong | Australia | |||
| 90 | Woolloongabba | Australia | |||
| 91 | Arlon | Belgium | |||
| 92 | Bonheiden | Belgium | |||
| 93 | Brussel | Belgium | |||
| 94 | Edegem | Belgium | |||
| 95 | Genk | Belgium | |||
| 96 | Leuven | Belgium | |||
| 97 | Calgary | Alberta | Canada | ||
| 98 | Coquitlam | British Columbia | Canada | ||
| 99 | Winnipeg | Manitoba | Canada | ||
| 100 | St. John'S | Newfoundland and Labrador | Canada | ||
| 101 | Brampton | Ontario | Canada | ||
| 102 | London | Ontario | Canada | ||
| 103 | Mississauga | Ontario | Canada | ||
| 104 | Nemarket | Ontario | Canada | ||
| 105 | Sarnia | Ontario | Canada | ||
| 106 | Sudbury | Ontario | Canada | ||
| 107 | Toronto | Ontario | Canada | ||
| 108 | Laval | Quebec | Canada | ||
| 109 | Lévis | Quebec | Canada | ||
| 110 | Montreal | Quebec | Canada | ||
| 111 | Val-Belair | Quebec | Canada | ||
| 112 | Saskatoon | Saskatchewan | Canada | ||
| 113 | Bogota | Colombia | |||
| 114 | Floridablanca | Colombia | |||
| 115 | Kralupy Nad Vltavou | Czechia | |||
| 116 | Moravsky Krumlov | Czechia | |||
| 117 | Olomouc 9 | Czechia | |||
| 118 | Ostrava | Czechia | |||
| 119 | Pisek | Czechia | |||
| 120 | Prague 5 | Czechia | |||
| 121 | Praha 11 | Czechia | |||
| 122 | Praha 8 | Czechia | |||
| 123 | Praha | Czechia | |||
| 124 | Znojmo N/A | Czechia | |||
| 125 | Pärnu | Estonia | |||
| 126 | Tallinn | Estonia | |||
| 127 | Tartu | Estonia | |||
| 128 | Viljandi | Estonia | |||
| 129 | Amiens | France | |||
| 130 | Nimes Cedex 9 | France | |||
| 131 | Pessac | France | |||
| 132 | Berlin | Germany | |||
| 133 | Dortmund | Germany | |||
| 134 | Dresden | Germany | |||
| 135 | Hamburg | Germany | |||
| 136 | Künzing | Germany | |||
| 137 | Mainz | Germany | |||
| 138 | Münster | Germany | |||
| 139 | Pirna | Germany | |||
| 140 | Saarlouis | Germany | |||
| 141 | Speyer | Germany | |||
| 142 | Villingen-Schwenningen | Germany | |||
| 143 | Budapest | Hungary | |||
| 144 | Kecskemet | Hungary | |||
| 145 | Mosonmagyaróvár | Hungary | |||
| 146 | Zalaegerszeg | Hungary | |||
| 147 | Ahemadabad | India | |||
| 148 | Ahmedabad | India | |||
| 149 | Ambawadi | India | |||
| 150 | Bangalore, Karnataka | India | |||
| 151 | Bangalore | India | |||
| 152 | Belgaum | India | |||
| 153 | Calicut | India | |||
| 154 | Chennai | India | |||
| 155 | Cochin | India | |||
| 156 | Coimbatore | India | |||
| 157 | Ernakulam | India | |||
| 158 | Ghaziabad | India | |||
| 159 | Hyderabad | India | |||
| 160 | Indore | India | |||
| 161 | Jaipur | India | |||
| 162 | Karnal | India | |||
| 163 | Kerala | India | |||
| 164 | Kochi | India | |||
| 165 | Kolkata | India | |||
| 166 | Lucknow | India | |||
| 167 | Mangalore | India | |||
| 168 | Mumbai | India | |||
| 169 | Mysore | India | |||
| 170 | Nagpur | India | |||
| 171 | New Delhi | India | |||
| 172 | Patna | India | |||
| 173 | Pune | India | |||
| 174 | Rajkot | India | |||
| 175 | Trivandrum, Kerala | India | |||
| 176 | Vadodhara | India | |||
| 177 | Vijayawada | India | |||
| 178 | Visakhapatnam | India | |||
| 179 | Beer Sheba | Israel | |||
| 180 | Holon | Israel | |||
| 181 | Jerusalem | Israel | |||
| 182 | Kfar Saba | Israel | |||
| 183 | Luxembourg | Luxembourg | |||
| 184 | Georgetown | Malaysia | |||
| 185 | Johor Bahru | Malaysia | |||
| 186 | Kota Bharu | Malaysia | |||
| 187 | Kuala Lumpur N/A | Malaysia | |||
| 188 | Petaling Jaya | Malaysia | |||
| 189 | Pulau Pinang | Malaysia | |||
| 190 | Subang Jaya | Malaysia | |||
| 191 | Aguascalientes | Mexico | |||
| 192 | Celaya | Mexico | |||
| 193 | Ciudad De Mexico | Mexico | |||
| 194 | Durango | Mexico | |||
| 195 | Guadalajara | Mexico | |||
| 196 | Monterrey | Mexico | |||
| 197 | Almelo | Netherlands | |||
| 198 | Almere | Netherlands | |||
| 199 | Amsterdam | Netherlands | |||
| 200 | Arnhem | Netherlands | |||
| 201 | Delft | Netherlands | |||
| 202 | Den Helder | Netherlands | |||
| 203 | Dordrecht | Netherlands | |||
| 204 | Eindhoven | Netherlands | |||
| 205 | Groningen | Netherlands | |||
| 206 | Hoorn Nh | Netherlands | |||
| 207 | Rotterdam | Netherlands | |||
| 208 | Tilburg | Netherlands | |||
| 209 | Utrecht | Netherlands | |||
| 210 | Velp Gld | Netherlands | |||
| 211 | Zoetermeer | Netherlands | |||
| 212 | Zwijndrecht | Netherlands | |||
| 213 | Auckland | New Zealand | |||
| 214 | Christchurch | New Zealand | |||
| 215 | Dunedin | New Zealand | |||
| 216 | Tauranga | New Zealand | |||
| 217 | Wellington | New Zealand | |||
| 218 | Alesund | Norway | |||
| 219 | Asker | Norway | |||
| 220 | Bekkestua | Norway | |||
| 221 | Elverum | Norway | |||
| 222 | Hamar | Norway | |||
| 223 | Lierskogen | Norway | |||
| 224 | Moss | Norway | |||
| 225 | Oslo | Norway | |||
| 226 | Skedsmokorset | Norway | |||
| 227 | Bialystok | Poland | |||
| 228 | Ciechocinek | Poland | |||
| 229 | Gniewkowo | Poland | |||
| 230 | Grudziadz | Poland | |||
| 231 | Katowice | Poland | |||
| 232 | Krakow | Poland | |||
| 233 | Lublin | Poland | |||
| 234 | Plock | Poland | |||
| 235 | Poznan | Poland | |||
| 236 | Rzeszow | Poland | |||
| 237 | Slawkow | Poland | |||
| 238 | Torun | Poland | |||
| 239 | Warszawa | Poland | |||
| 240 | Wroclaw | Poland | |||
| 241 | Arkhangelsk | Russian Federation | |||
| 242 | Chelyabinsk | Russian Federation | |||
| 243 | Ekaterinburg | Russian Federation | |||
| 244 | Kemerovo | Russian Federation | |||
| 245 | Kirov | Russian Federation | |||
| 246 | Kursk | Russian Federation | |||
| 247 | Moscow N/A | Russian Federation | |||
| 248 | Moscow | Russian Federation | |||
| 249 | Nizhny Novgorod | Russian Federation | |||
| 250 | Novosibirsk | Russian Federation | |||
| 251 | Omsk | Russian Federation | |||
| 252 | Penza | Russian Federation | |||
| 253 | Rostov-On-Don | Russian Federation | |||
| 254 | Russia | Russian Federation | |||
| 255 | Ryazan | Russian Federation | |||
| 256 | Saint Petersburg | Russian Federation | |||
| 257 | Saint-Petersburg | Russian Federation | |||
| 258 | Saratov | Russian Federation | |||
| 259 | Smolensk | Russian Federation | |||
| 260 | St Petersburg | Russian Federation | |||
| 261 | Tomsk | Russian Federation | |||
| 262 | Tula | Russian Federation | |||
| 263 | Tyumen | Russian Federation | |||
| 264 | Yaroslavl Nap | Russian Federation | |||
| 265 | Yaroslavl | Russian Federation | |||
| 266 | Alicante | Spain | |||
| 267 | Almeria | Spain | |||
| 268 | Barcelona | Spain | |||
| 269 | Figueres | Spain | |||
| 270 | Madrid | Spain | |||
| 271 | Málaga | Spain | |||
| 272 | Oviedo | Spain | |||
| 273 | Reus | Spain | |||
| 274 | Sabadell | Spain | |||
| 275 | San Juan De Alicante | Spain | |||
| 276 | Santiago De Compostela | Spain | |||
| 277 | Sevilla N/A | Spain | |||
| 278 | Valencia | Spain | |||
| 279 | Viladecans | Spain | |||
| 280 | Borås | Sweden | |||
| 281 | Göteborg | Sweden | |||
| 282 | Helsingborg | Sweden | |||
| 283 | Lund | Sweden | |||
| 284 | Malmö | Sweden | |||
| 285 | Oskarshamn N/A | Sweden | |||
| 286 | Piteå | Sweden | |||
| 287 | Stockholm | Sweden | |||
| 288 | Uddevalla | Sweden | |||
| 289 | Dnepropetrovsk | Ukraine | |||
| 290 | Donetsk | Ukraine | |||
| 291 | Kharkov | Ukraine | |||
| 292 | Kiev | Ukraine | |||
| 293 | Kyiv | Ukraine | |||
| 294 | Odessa | Ukraine | |||
| 295 | Ternopol | Ukraine | |||
| 296 | Uzhgorod | Ukraine | |||
| 297 | Vinnitsa | Ukraine | |||
| 298 | Zaporozhye | Ukraine | |||
| 299 | Belfast | United Kingdom | |||
| 300 | Blackburn | United Kingdom | |||
| 301 | Bolton | United Kingdom | |||
| 302 | Chorley | United Kingdom | |||
| 303 | Derby | United Kingdom | |||
| 304 | Glasgow | United Kingdom | |||
| 305 | Hull | United Kingdom | |||
| 306 | Leicester | United Kingdom | |||
| 307 | Liverpool | United Kingdom | |||
| 308 | Londonderry | United Kingdom | |||
| 309 | London | United Kingdom | |||
| 310 | Manchester | United Kingdom | |||
| 311 | Randalstown | United Kingdom | |||
| 312 | Salford | United Kingdom | |||
| 313 | York | United Kingdom |
Sponsors and Collaborators
- Janssen Research & Development, LLC
- The George Institute for Global Health, Australia
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01032629
Other Study ID Numbers:
- CR016627
- 28431754DIA3008
- 2009-012140-16
First Posted:
Dec 15, 2009
Last Update Posted:
Dec 7, 2018
Last Verified:
Nov 1, 2018
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Janssen Research & Development, LLC
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | No Text enterred |
| Arm/Group Title | Placebo | Canagliflozin 100 mg | Canagliflozin 300 mg |
|---|---|---|---|
| Arm/Group Description | Participants received one placebo capsule orally once daily for the duration of the study or until early discontinuation from treatment. | Participants received one canagliflozin 100 milligram (mg) capsule once daily for the duration of the study or until early discontinuation from treatment. | Participants received one canagliflozin 300 mg capsule once daily for the duration of the study or until early discontinuation from treatment. |
| Period Title: Overall Study | |||
| STARTED | 1442 | 1445 | 1443 |
| Treated | 1441 | 1445 | 1441 |
| COMPLETED | 1297 | 1344 | 1355 |
| NOT COMPLETED | 145 | 101 | 88 |
Baseline Characteristics
| Arm/Group Title | Placebo | Canagliflozin 100 mg | Canagliflozin 300 mg | Total |
|---|---|---|---|---|
| Arm/Group Description | Participants received one placebo capsule orally once daily for the duration of the study or until early discontinuation from treatment. | Participants received one canagliflozin 100 milligram (mg) capsule once daily for the duration of the study or until early discontinuation from treatment. | Participants received one canagliflozin 300 mg capsule once daily for the duration of the study or until early discontinuation from treatment. | Total of all reporting groups |
| Overall Participants | 1442 | 1445 | 1443 | 4330 |
| Age (Years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [Years] |
62.3
(7.94)
|
62.2
(8)
|
62.8
(8.13)
|
62.4
(8.02)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
486
33.7%
|
484
33.5%
|
499
34.6%
|
1469
33.9%
|
| Male |
956
66.3%
|
961
66.5%
|
944
65.4%
|
2861
66.1%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Hispanic or Latino |
149
10.3%
|
142
9.8%
|
125
8.7%
|
416
9.6%
|
| Not Hispanic or Latino |
1288
89.3%
|
1300
90%
|
1317
91.3%
|
3905
90.2%
|
| Unknown or Not Reported |
5
0.3%
|
3
0.2%
|
1
0.1%
|
9
0.2%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
3
0.2%
|
1
0.1%
|
1
0.1%
|
5
0.1%
|
| Asian |
262
18.2%
|
270
18.7%
|
263
18.2%
|
795
18.4%
|
| Native Hawaiian or Other Pacific Islander |
1
0.1%
|
2
0.1%
|
3
0.2%
|
6
0.1%
|
| Black or African American |
35
2.4%
|
32
2.2%
|
38
2.6%
|
105
2.4%
|
| White |
1064
73.8%
|
1060
73.4%
|
1055
73.1%
|
3179
73.4%
|
| More than one race |
10
0.7%
|
8
0.6%
|
13
0.9%
|
31
0.7%
|
| Unknown or Not Reported |
67
4.6%
|
72
5%
|
70
4.9%
|
209
4.8%
|
| Race/Ethnicity, Customized (Count of Participants) | ||||
| Asian |
262
18.2%
|
270
18.7%
|
263
18.2%
|
795
18.4%
|
| Black or African American |
35
2.4%
|
32
2.2%
|
38
2.6%
|
105
2.4%
|
| Hispanic or Latino |
134
9.3%
|
123
8.5%
|
106
7.3%
|
363
8.4%
|
| Other |
82
5.7%
|
86
6%
|
88
6.1%
|
256
5.9%
|
| White Non- Hispanic |
929
64.4%
|
934
64.6%
|
948
65.7%
|
2811
64.9%
|
| Region of Enrollment (Count of Participants) | ||||
| Argentina |
57
4%
|
48
3.3%
|
55
3.8%
|
160
3.7%
|
| Australia |
57
4%
|
60
4.2%
|
60
4.2%
|
177
4.1%
|
| Belgium |
3
0.2%
|
10
0.7%
|
8
0.6%
|
21
0.5%
|
| Canada |
134
9.3%
|
139
9.6%
|
123
8.5%
|
396
9.1%
|
| Colombia |
4
0.3%
|
1
0.1%
|
2
0.1%
|
7
0.2%
|
| Czech Republic |
37
2.6%
|
37
2.6%
|
43
3%
|
117
2.7%
|
| Estonia |
19
1.3%
|
13
0.9%
|
12
0.8%
|
44
1%
|
| Germany |
47
3.3%
|
62
4.3%
|
66
4.6%
|
175
4%
|
| Hungary |
38
2.6%
|
50
3.5%
|
37
2.6%
|
125
2.9%
|
| India |
229
15.9%
|
232
16.1%
|
234
16.2%
|
695
16.1%
|
| Israel |
5
0.3%
|
11
0.8%
|
9
0.6%
|
25
0.6%
|
| Luxembourg |
1
0.1%
|
0
0%
|
0
0%
|
1
0%
|
| Malaysia |
32
2.2%
|
24
1.7%
|
17
1.2%
|
73
1.7%
|
| Mexico |
40
2.8%
|
48
3.3%
|
36
2.5%
|
124
2.9%
|
| Netherlands |
70
4.9%
|
77
5.3%
|
81
5.6%
|
228
5.3%
|
| New Zealand |
27
1.9%
|
22
1.5%
|
25
1.7%
|
74
1.7%
|
| Norway |
41
2.8%
|
33
2.3%
|
35
2.4%
|
109
2.5%
|
| Poland |
47
3.3%
|
54
3.7%
|
43
3%
|
144
3.3%
|
| Russia |
146
10.1%
|
118
8.2%
|
125
8.7%
|
389
9%
|
| Spain |
64
4.4%
|
74
5.1%
|
71
4.9%
|
209
4.8%
|
| Sweden |
23
1.6%
|
26
1.8%
|
22
1.5%
|
71
1.6%
|
| Ukraine |
50
3.5%
|
39
2.7%
|
58
4%
|
147
3.4%
|
| United Kingdom |
31
2.1%
|
29
2%
|
32
2.2%
|
92
2.1%
|
| United States |
240
16.6%
|
238
16.5%
|
249
17.3%
|
727
16.8%
|
Outcome Measures
| Title | Major Adverse Cardiovascular Events (MACE) Composite of Cardiovascular (CV) Death, Non-Fatal Myocardial Infarction (MI), and Non-Fatal Stroke |
|---|---|
| Description | MACE, defined as a composite of CV death, non-fatal MI, and nonfatal stroke. Adjudication of these events by the Endpoint Adjudication Committee (EAC) was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of MACE are presented. |
| Time Frame | Up to approximately 8 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| The primary analysis was based on the intent-to-treat (ITT) analysis set for adjudicated MACE, and included all randomized participants. As per planned analysis, the results were reported separately and combined for both doses. |
| Arm/Group Title | Placebo | Canagliflozin 100 mg | Canagliflozin 300 mg | Canagliflozin (Total) |
|---|---|---|---|---|
| Arm/Group Description | Participants received one placebo capsule orally once daily for the duration of the study or until early discontinuation from treatment. | Participants received one canagliflozin 100 milligram (mg) capsule once daily for the duration of the study or until early discontinuation from treatment. | Participants received one canagliflozin 300 mg capsule once daily for the duration of the study or until early discontinuation from treatment. | Participants received one canagliflozin 100 mg or 300 mg capsule once daily for the duration of the study or until early discontinuation from treatment. |
| Measure Participants | 1442 | 1445 | 1443 | 2888 |
| Number [Events per 1000 patient-year] |
30.36
|
28.41
|
25.37
|
26.89
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Canagliflozin 100 mg |
|---|---|---|
| Comments | Comparison for canagliflozin versus placebo is reported here. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | =0.4576 |
| Comments | ||
| Method | Cox proportional hazard model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.93 | |
| Confidence Interval |
(2-Sided) 95% 0.78 to 1.12 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Canagliflozin 300 mg |
|---|---|---|
| Comments | Comparison for canagliflozin versus placebo is reported here. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | =0.0467 |
| Comments | ||
| Method | Cox proportional hazard model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.83 | |
| Confidence Interval |
(2-Sided) 95% 0.68 to 1.00 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Canagliflozin (Total) |
|---|---|---|
| Comments | Comparison for canagliflozin versus placebo is reported here. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1120 |
| Comments | ||
| Method | Cox proportional hazard method | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.88 | |
| Confidence Interval |
(2-Sided) 95% 0.75 to 1.03 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in Homeostasis Model Assessment 2 Steady-State Beta-Cell Function (HOMA2-%B) at the End-of-Treatment (EOT) |
|---|---|
| Description | The homeostatic model assessment (HOMA) quantifies insulin resistance and beta-cell function. HOMA2-%B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady-state beta cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100 percent. |
| Time Frame | Baseline and end of treatment (approximately 338 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| On-treatment analysis set included all randomized participants who received at least 1 dose of study drug. Here 'N' (number of participants analyzed) included subset of participants who were not receiving insulin at baseline and had at least one post-baseline HOMA2-%B measurement on-treatment prior to initiation of insulin. |
| Arm/Group Title | Placebo | Canagliflozin 100 mg | Canagliflozin 300 mg |
|---|---|---|---|
| Arm/Group Description | Participants received one placebo capsule orally once daily for the duration of the study or until early discontinuation from treatment. | Participants received one canagliflozin 100 milligram (mg) capsule once daily for the duration of the study or until early discontinuation from treatment. | Participants received one canagliflozin 300 mg capsule once daily for the duration of the study or until early discontinuation from treatment. |
| Measure Participants | 463 | 511 | 477 |
| Least Squares Mean (Standard Error) [Percentage of HOMA2] |
4.02
(1.611)
|
6.82
(1.533)
|
8.09
(1.587)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Canagliflozin 100 mg |
|---|---|---|
| Comments | Comparison for canagliflozin versus placebo is reported here. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | =0.210 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference of Least Square Mean |
| Estimated Value | 2.79 | |
| Confidence Interval |
(2-Sided) 95% -1.571 to 7.154 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.224 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Canagliflozin 300 mg |
|---|---|---|
| Comments | Comparison for canagliflozin versus placebo is reported here. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | =0.072 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference of Least Square Mean |
| Estimated Value | 4.07 | |
| Confidence Interval |
(2-Sided) 95% -0.368 to 8.504 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.261 |
|
| Estimation Comments | ||
| Title | Percentage of Participants With Progression of Albuminuria at the End-of-Treatment |
|---|---|
| Description | Progression defined as the development of micro-albuminuria (albumin/creatinine ratio (ACR) greater than or equal to [>=] 30 milligram per gram (mg/g) and less than or equal to <= 300 mg/g) or macroalbuminuria (ACR of >300 mg/g) in a participant with baseline normoalbuminuria or the development of macro-albuminuria in a participant with baseline microalbuminuria. Percentage of participants with progression of albuminuria at the end-of-treatment were assessed. |
| Time Frame | End of treatment (approximately 338 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| On-treatment analysis set included all randomized participants who received at least 1 dose of study drug. Here 'N' (number of participants analyzed) signifies number of participants who were treated, had both baseline and post-baseline ACR measurements, and baseline ACR<=300 mg/g. |
| Arm/Group Title | Placebo | Canagliflozin 100 mg | Canagliflozin 300 mg |
|---|---|---|---|
| Arm/Group Description | Participants received one placebo capsule orally once daily for the duration of the study or until early discontinuation from treatment. | Participants received one canagliflozin 100 milligram (mg) capsule once daily for the duration of the study or until early discontinuation from treatment. | Participants received one canagliflozin 300 mg capsule once daily for the duration of the study or until early discontinuation from treatment. |
| Measure Participants | 1286 | 1334 | 1298 |
| Number [Percentage of participants] |
24.0
1.7%
|
20.2
1.4%
|
18.3
1.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Canagliflozin 100 mg |
|---|---|---|
| Comments | Comparison for canagliflozin versus placebo is reported here. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.80 | |
| Confidence Interval |
(2-Sided) 95% 0.67 to 0.97 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Canagliflozin 300 mg |
|---|---|---|
| Comments | Comparison for canagliflozin versus placebo is reported here. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.71 | |
| Confidence Interval |
(2-Sided) 95% 0.58 to 0.85 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in Proinsulin/Insulin (PI/I) Ratio at the End-of-Treatment |
|---|---|
| Description | A raised proinsulin-to-insulin ratio due to impaired processing of proinsulin is an early marker of beta cell dysfunction. Beta-cell dysfunction was evaluated by calculating the PI/I ratio, which estimates the capacity of beta cells to convert proinsulin to insulin and may represent an acceptable method to indicate the degree of beta-cell secretion. |
| Time Frame | Baseline and end of treatment (approximately 338 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| On-treatment analysis set: all randomized participants who received at least 1 dose of study drug. 'N' (number of participants analyzed): number of participants evaluable for this outcome measure, had both baseline and any post-baseline PI/I ratio measurements on-treatment prior to initiation of insulin and didn't receive insulin through baseline. |
| Arm/Group Title | Placebo | Canagliflozin 100 mg | Canagliflozin 300 mg |
|---|---|---|---|
| Arm/Group Description | Participants received one placebo capsule orally once daily for the duration of the study or until early discontinuation from treatment. | Participants received one canagliflozin 100 milligram (mg) capsule once daily for the duration of the study or until early discontinuation from treatment. | Participants received one canagliflozin 300 mg capsule once daily for the duration of the study or until early discontinuation from treatment. |
| Measure Participants | 370 | 426 | 412 |
| Least Squares Mean (Standard Error) [Picomole per milli international units] |
0.70
(0.150)
|
0.67
(0.140)
|
1.03
(0.142)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Canagliflozin 100 mg |
|---|---|---|
| Comments | Comparison for canagliflozin versus placebo is reported here. | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference of Least Square Mean |
| Estimated Value | -0.03 | |
| Confidence Interval |
(2-Sided) 95% -0.429 to 0.374 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.205 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Canagliflozin 300 mg |
|---|---|---|
| Comments | Comparison for canagliflozin versus placebo is reported here. | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference of Least Square Mean |
| Estimated Value | 0.33 | |
| Confidence Interval |
(2-Sided) 95% -0.079 to 0.731 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.206 |
|
| Estimation Comments | ||
| Title | Change From Baseline in Urinary Albumin/Creatinine Ratio at End-of-Treatment |
|---|---|
| Description | Urinary Albumin/Creatinine Ratio is a potential marker of chronic kidney disease, calculated as a ratio of Urinary Albumin and Urinary Creatinine. |
| Time Frame | Baseline and End of treatment (approximately 338 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| On-treatment analysis set included all randomized participants who received at least 1 dose of study drug. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and had both baseline and post-baseline ACR measurements. |
| Arm/Group Title | Placebo | Canagliflozin 100 mg | Canagliflozin 300 mg |
|---|---|---|---|
| Arm/Group Description | Participants received one placebo capsule orally once daily for the duration of the study or until early discontinuation from treatment. | Participants received one canagliflozin 100 milligram (mg) capsule once daily for the duration of the study or until early discontinuation from treatment. | Participants received one canagliflozin 300 mg capsule once daily for the duration of the study or until early discontinuation from treatment. |
| Measure Participants | 1377 | 1398 | 1384 |
| Geometric Mean (95% Confidence Interval) [Milligram per gram (mg/g)] |
29.30
|
25.50
|
24.47
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Canagliflozin 100 mg |
|---|---|---|
| Comments | Comparison for canagliflozin versus placebo is reported here. | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Geometric mean ratio |
| Estimated Value | 0.87 | |
| Confidence Interval |
(2-Sided) 95% 0.800 to 0.940 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Canagliflozin 300 mg |
|---|---|---|
| Comments | Comparison for canagliflozin versus placebo is reported here. | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Geometric mean ratio |
| Estimated Value | 0.84 | |
| Confidence Interval |
(2-Sided) 95% 0.770 to 0.910 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at End-of-Treatment |
|---|---|
| Description | Change from baseline in Estimated Glomerular Filtration Rate (eGFR) was assessed at end of treatment. GFR is a measure of the rate at which blood is filtered by the kidney. Modification of Diet in Renal Disease (MDRD) is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and sex. eGFR milliliters/minute/1.73 meters square (mL/min/1.73 m^2) = 175 * (serum creatinine) ^ 1.154 * (Age) ^-0.203 *(0.742 if female) * (1.21 if Black). |
| Time Frame | Baseline and end of treatment (approximately 338 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| On-treatment analysis set included all randomized participants who received at least 1 dose of study drug. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure who had both baseline and post-baseline eGFR measurements. |
| Arm/Group Title | Placebo | Canagliflozin 100 mg | Canagliflozin 300 mg |
|---|---|---|---|
| Arm/Group Description | Participants received one placebo capsule orally once daily for the duration of the study or until early discontinuation from treatment. | Participants received one canagliflozin 100 milligram (mg) capsule once daily for the duration of the study or until early discontinuation from treatment. | Participants received one canagliflozin 300 mg capsule once daily for the duration of the study or until early discontinuation from treatment. |
| Measure Participants | 1394 | 1412 | 1383 |
| Least Squares Mean (Standard Error) [mL/min/1.73 m^2] |
-5.23
(0.390)
|
-3.55
(0.388)
|
-3.98
(0.392)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Canagliflozin 100 mg |
|---|---|---|
| Comments | Comparison for canagliflozin versus placebo is reported here. | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference of Least Square Mean |
| Estimated Value | 1.68 | |
| Confidence Interval |
(2-Sided) 95% 0.599 to 2.755 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.550 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Canagliflozin 300 mg |
|---|---|---|
| Comments | Comparison for canagliflozin versus placebo is reported here. | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference of Least Square Mean |
| Estimated Value | 1.24 | |
| Confidence Interval |
(2-Sided) 95% 0.160 to 2.328 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.553 |
|
| Estimation Comments | ||
| Title | Change From Baseline in Glycated Hemoglobin (HbA1c) at End-of-Treatment |
|---|---|
| Description | Change from baseline in glycated hemoglobin (HbA1c) percentage (%) was assessed at end of treatment. Glycated hemoglobin is a form of hemoglobin that is measured primarily to identify the average glucose concentration in the blood. |
| Time Frame | Baseline and end of treatment (approximately 338 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| On-treatment analysis set included all randomized participants who received at least 1 dose of study drug. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure who had both baseline and any post-baseline HbA1C measurements. |
| Arm/Group Title | Placebo | Canagliflozin 100 mg | Canagliflozin 300 mg |
|---|---|---|---|
| Arm/Group Description | Participants received one placebo capsule orally once daily for the duration of the study or until early discontinuation from treatment. | Participants received one canagliflozin 100 milligram (mg) capsule once daily for the duration of the study or until early discontinuation from treatment. | Participants received one canagliflozin 300 mg capsule once daily for the duration of the study or until early discontinuation from treatment. |
| Measure Participants | 1366 | 1392 | 1352 |
| Least Squares Mean (Standard Error) [HbA1c (%)] |
0.01
(0.032)
|
-0.26
(0.032)
|
-0.31
(0.032)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Canagliflozin 100 mg |
|---|---|---|
| Comments | Comparison for canagliflozin versus placebo is reported here. | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference of Least Square Mean |
| Estimated Value | -0.27 | |
| Confidence Interval |
(2-Sided) 95% -0.355 to -0.177 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.045 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Canagliflozin 300 mg |
|---|---|---|
| Comments | Comparison for canagliflozin versus placebo is reported here. | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference of Least Square Mean |
| Estimated Value | -0.32 | |
| Confidence Interval |
(2-Sided) 95% -0.405 to -0.227 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.046 |
|
| Estimation Comments | ||
| Title | Change From Baseline in Fasting Plasma Glucose (FPG) Levels at End-of-Treatment |
|---|---|
| Description | Change from baseline in the fasting plasma glucose levels at end-of-treatment was assessed. |
| Time Frame | Baseline and end of treatment (approximately 338 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| On-treatment analysis set included all randomized participants who received at least 1 dose of study drug. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and had both baseline and post-baseline fasting plasma glucose measurements. |
| Arm/Group Title | Placebo | Canagliflozin 100 mg | Canagliflozin 300 mg |
|---|---|---|---|
| Arm/Group Description | Participants received one placebo capsule orally once daily for the duration of the study or until early discontinuation from treatment. | Participants received one canagliflozin 100 milligram (mg) capsule once daily for the duration of the study or until early discontinuation from treatment. | Participants received one canagliflozin 300 mg capsule once daily for the duration of the study or until early discontinuation from treatment. |
| Measure Participants | 1392 | 1410 | 1377 |
| Least Squares Mean (Standard Error) [Millimoles per liter (mmol/L)] |
0.16
(0.076)
|
-0.42
(0.075)
|
-0.57
(0.076)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Canagliflozin 100 mg |
|---|---|---|
| Comments | Comparison for canagliflozin versus placebo is reported here. | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference of Least Square Mean |
| Estimated Value | -0.58 | |
| Confidence Interval |
(2-Sided) 95% -0.794 to -0.374 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.107 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Canagliflozin 300 mg |
|---|---|---|
| Comments | Comparison for canagliflozin versus placebo is reported here. | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference of Least Square Mean |
| Estimated Value | -0.73 | |
| Confidence Interval |
(2-Sided) 95% -0.945 to -0.523 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.108 |
|
| Estimation Comments | ||
| Title | Percent Change From Baseline in Body Weight at End-of-Treatment |
|---|---|
| Description | Percent change from baseline in body weight was assessed at the end of treatment. |
| Time Frame | Baseline and end of treatment (approximately 338 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| On-treatment analysis set included all randomized participants who received at least 1 dose of study drug. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and who had both baseline and post-baseline body weight. |
| Arm/Group Title | Placebo | Canagliflozin 100 mg | Canagliflozin 300 mg |
|---|---|---|---|
| Arm/Group Description | Participants received one placebo capsule orally once daily for the duration of the study or until early discontinuation from treatment. | Participants received one canagliflozin 100 milligram (mg) capsule once daily for the duration of the study or until early discontinuation from treatment. | Participants received one canagliflozin 300 mg capsule once daily for the duration of the study or until early discontinuation from treatment. |
| Measure Participants | 1398 | 1415 | 1388 |
| Least Squares Mean (Standard Error) [Percent change] |
-0.50
(0.184)
|
-3.47
(0.183)
|
-4.12
(0.185)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Canagliflozin 100 mg |
|---|---|---|
| Comments | Comparison for canagliflozin versus placebo is reported here. | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference of Least Square Mean |
| Estimated Value | -2.96 | |
| Confidence Interval |
() 95% -3.472 to -2.454 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.260 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Canagliflozin 300 mg |
|---|---|---|
| Comments | Comparison for canagliflozin versus placebo is reported here. | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference of Least Square Mean |
| Estimated Value | -3.61 | |
| Confidence Interval |
(2-Sided) 95% -4.125 to -3.103 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.261 |
|
| Estimation Comments | ||
| Title | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at End-of-Treatment |
|---|---|
| Description | Change from baseline in systolic blood pressure and diastolic blood pressure was assessed. |
| Time Frame | Baseline and end of treatment (approximately 338 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| On-treatment analysis set included all randomized participants who received at least 1 dose of study drug. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure who and had both baseline and post-baseline blood pressure measurements. |
| Arm/Group Title | Placebo | Canagliflozin 100 mg | Canagliflozin 300 mg |
|---|---|---|---|
| Arm/Group Description | Participants received one placebo capsule orally once daily for the duration of the study or until early discontinuation from treatment. | Participants received one canagliflozin 100 milligram (mg) capsule once daily for the duration of the study or until early discontinuation from treatment. | Participants received one canagliflozin 300 mg capsule once daily for the duration of the study or until early discontinuation from treatment. |
| Measure Participants | 1398 | 1415 | 1388 |
| SBP(Change at end of treatment) |
-1.96
(0.377)
|
-4.91
(0.375)
|
-6.49
(0.378)
|
| DBP (Change at end of treatment) |
-2.88
(0.223)
|
-3.70
(0.221)
|
-4.51
(0.223)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Canagliflozin 100 mg |
|---|---|---|
| Comments | Statistical analysis (Systolic blood pressure) Comparison for canagliflozin versus placebo is reported here. | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference of Least Square Mean |
| Estimated Value | -2.96 | |
| Confidence Interval |
(2-Sided) 95% -3.998 to -1.914 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.532 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Canagliflozin 300 mg |
|---|---|---|
| Comments | Statistical analysis (Systolic blood pressure) Comparison for canagliflozin versus placebo is reported here. | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference of Least Square Mean |
| Estimated Value | -4.53 | |
| Confidence Interval |
(2-Sided) 95% -5.579 to -3.484 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.534 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Canagliflozin 100 mg |
|---|---|---|
| Comments | Statistical analysis (Diastolic blood pressure) Comparison for canagliflozin versus placebo is reported here. | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference of Least Square Mean |
| Estimated Value | -0.82 | |
| Confidence Interval |
(2-Sided) 95% -1.437 to -0.205 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.314 |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Canagliflozin 300 mg |
|---|---|---|
| Comments | Statistical analysis (Diastolic blood pressure) Comparison for canagliflozin versus placebo is reported here. | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference of Least Square Mean |
| Estimated Value | -1.63 | |
| Confidence Interval |
(2-Sided) 95% -2.245 to -1.007 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.316 |
|
| Estimation Comments | ||
| Title | Change From Baseline in Triglycerides Levels at End-of-Treatment |
|---|---|
| Description | Change from baseline in triglycerides levels was assessed. |
| Time Frame | Baseline and end of treatment (approximately 338 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| On-treatment set included all randomized participants who received at least 1 dose of study drug. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and who had both baseline and post-baseline lipid measurements. |
| Arm/Group Title | Placebo | Canagliflozin 100 mg | Canagliflozin 300 mg |
|---|---|---|---|
| Arm/Group Description | Participants received one placebo capsule orally once daily for the duration of the study or until early discontinuation from treatment. | Participants received one canagliflozin 100 milligram (mg) capsule once daily for the duration of the study or until early discontinuation from treatment. | Participants received one canagliflozin 300 mg capsule once daily for the duration of the study or until early discontinuation from treatment. |
| Measure Participants | 1325 | 1371 | 1321 |
| Mean (Standard Deviation) [mmol/L] |
0.05
(1.597)
|
0.13
(1.679)
|
0.09
(1.238)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Canagliflozin 100 mg |
|---|---|---|
| Comments | Comparison for canagliflozin versus placebo is reported here. | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hodges-Lehman Estimate |
| Estimated Value | 0.02 | |
| Confidence Interval |
(2-Sided) 95% -0.040 to 0.070 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Canagliflozin 300 mg |
|---|---|---|
| Comments | Comparison for canagliflozin versus placebo is reported here. | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hodges-Lehman Estimate |
| Estimated Value | 0.02 | |
| Confidence Interval |
(2-Sided) 95% -0.030 to 0.080 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in Cholesterol, High-Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) Levels at End-of-Treatment |
|---|---|
| Description | Change from baseline in cholesterol, high-density lipoprotein cholesterol and low density lipoprotein cholesterol levels were assessed. |
| Time Frame | Baseline and end of treatment (approximately 338 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| On-treatment set included all randomized participants who received at least 1 dose of study drug. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and who had both baseline and post-baseline lipid measurements. |
| Arm/Group Title | Placebo | Canagliflozin 100 mg | Canagliflozin 300 mg |
|---|---|---|---|
| Arm/Group Description | Participants received one placebo capsule orally once daily for the duration of the study or until early discontinuation from treatment. | Participants received one canagliflozin 100 milligram (mg) capsule once daily for the duration of the study or until early discontinuation from treatment. | Participants received one canagliflozin 300 mg capsule once daily for the duration of the study or until early discontinuation from treatment. |
| Measure Participants | 1325 | 1371 | 1321 |
| Cholesterol (change at EOT) |
-0.07
(0.028)
|
0.11
(0.027)
|
0.16
(0.028)
|
| HDL-C (change at EOT) |
-0.01
(0.006)
|
0.04
(0.006)
|
0.05
(0.006)
|
| LDL-C (change at EOT) |
-0.07
(0.022)
|
0.04
(0.022)
|
0.10
(0.023)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Canagliflozin 100 mg |
|---|---|---|
| Comments | Statistical analysis (Cholesterol) Comparison for canagliflozin versus placebo is reported here. | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference of Least Square Mean |
| Estimated Value | 0.18 | |
| Confidence Interval |
(2-Sided) 95% 0.105 to 0.259 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.039 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Canagliflozin 300 mg |
|---|---|---|
| Comments | Statistical analysis (Cholesterol) Comparison for canagliflozin versus placebo is reported here. | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference of Least Square Mean |
| Estimated Value | 0.23 | |
| Confidence Interval |
(2-Sided) 95% 0.152 to 0.307 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.039 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Canagliflozin 100 mg |
|---|---|---|
| Comments | Statistical analysis (HDL-C) | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference of Least Square Mean |
| Estimated Value | 0.05 | |
| Confidence Interval |
(2-Sided) 95% 0.031 to 0.065 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.009 |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Canagliflozin 300 mg |
|---|---|---|
| Comments | Statistical analysis (HDL-C) Comparison for canagliflozin versus placebo is reported here. | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference of Least Square Mean |
| Estimated Value | 0.06 | |
| Confidence Interval |
(2-Sided) 95% 0.040 to 0.075 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.009 |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Canagliflozin 100 mg |
|---|---|---|
| Comments | Statistical analysis (LDL-C) Comparison for canagliflozin versus placebo is reported here. | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference of Least Square Mean |
| Estimated Value | 0.11 | |
| Confidence Interval |
(2-Sided) 95% 0.046 to 0.170 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.032 |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Canagliflozin 300 mg |
|---|---|---|
| Comments | Statistical analysis (LDL-C) Comparison for canagliflozin versus placebo is reported here. | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference of Least Square Mean |
| Estimated Value | 0.16 | |
| Confidence Interval |
(2-Sided) 95% 0.102 to 0.226 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.032 |
|
| Estimation Comments | ||
| Title | Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) to High-Density Lipoprotein-Cholesterol (HDL-C) Ratio at End-of-Treatment |
|---|---|
| Description | Change from baseline in LDL-C to HDL-C ratio was assessed. |
| Time Frame | Baseline and end of treatment (approximately 338 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| On-treatment set included all randomized participants who received at least 1 dose of study drug. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and who had both baseline and post-baseline lipid measurements. |
| Arm/Group Title | Placebo | Canagliflozin 100 mg | Canagliflozin 300 mg |
|---|---|---|---|
| Arm/Group Description | Participants received one placebo capsule orally once daily for the duration of the study or until early discontinuation from treatment. | Participants received one canagliflozin 100 milligram (mg) capsule once daily for the duration of the study or until early discontinuation from treatment. | Participants received one canagliflozin 300 mg capsule once daily for the duration of the study or until early discontinuation from treatment. |
| Measure Participants | 1325 | 1371 | 1321 |
| Least Squares Mean (Standard Error) [Ratio] |
-0.04
(0.021)
|
-0.02
(0.021)
|
0.00
(0.021)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Canagliflozin 100 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference of Least Square Mean |
| Estimated Value | 0.02 | |
| Confidence Interval |
(2-Sided) 95% -0.040 to 0.076 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.030 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Canagliflozin 300 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference of Least Square Mean |
| Estimated Value | 0.04 | |
| Confidence Interval |
(2-Sided) 95% -0.023 to 0.094 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.030 |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | Approximately 8 years | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. | |||||
| Arm/Group Title | Placebo | Canagliflozin 100 mg | Canagliflozin 300 mg | |||
| Arm/Group Description | Participants received one placebo capsule orally once daily for the duration of the study or until early discontinuation from treatment. | Participants received one canagliflozin 100 milligram (mg) capsule once daily for the duration of the study or until early discontinuation from treatment. | Participants received one canagliflozin 300 mg capsule once daily for the duration of the study or until early discontinuation from treatment. | |||
All Cause Mortality |
||||||
| Placebo | Canagliflozin 100 mg | Canagliflozin 300 mg | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 74/1441 (5.1%) | 68/1445 (4.7%) | 66/1441 (4.6%) | |||
Serious Adverse Events |
||||||
| Placebo | Canagliflozin 100 mg | Canagliflozin 300 mg | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 584/1441 (40.5%) | 601/1445 (41.6%) | 606/1441 (42.1%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia | 8/1441 (0.6%) | 2/1445 (0.1%) | 7/1441 (0.5%) | |||
| Haemorrhagic Anaemia | 0/1441 (0%) | 0/1445 (0%) | 2/1441 (0.1%) | |||
| Hypochromic Anaemia | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Iron Deficiency Anaemia | 0/1441 (0%) | 2/1445 (0.1%) | 1/1441 (0.1%) | |||
| Microcytic Anaemia | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Normochromic Normocytic Anaemia | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Pancytopenia | 0/1441 (0%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Pernicious Anaemia | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Splenomegaly | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Thrombocytopenia | 1/1441 (0.1%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Cardiac disorders | ||||||
| Acute Coronary Syndrome | 8/1441 (0.6%) | 3/1445 (0.2%) | 3/1441 (0.2%) | |||
| Acute Left Ventricular Failure | 0/1441 (0%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Acute Myocardial Infarction | 10/1441 (0.7%) | 10/1445 (0.7%) | 8/1441 (0.6%) | |||
| Adams-Stokes Syndrome | 1/1441 (0.1%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Angina Pectoris | 24/1441 (1.7%) | 15/1445 (1%) | 30/1441 (2.1%) | |||
| Angina Unstable | 20/1441 (1.4%) | 24/1445 (1.7%) | 28/1441 (1.9%) | |||
| Anginal Equivalent | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Aortic Valve Incompetence | 0/1441 (0%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Aortic Valve Stenosis | 1/1441 (0.1%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Arrhythmia | 3/1441 (0.2%) | 0/1445 (0%) | 4/1441 (0.3%) | |||
| Arteriosclerosis Coronary Artery | 1/1441 (0.1%) | 1/1445 (0.1%) | 3/1441 (0.2%) | |||
| Atrial Fibrillation | 26/1441 (1.8%) | 22/1445 (1.5%) | 17/1441 (1.2%) | |||
| Atrial Flutter | 6/1441 (0.4%) | 6/1445 (0.4%) | 8/1441 (0.6%) | |||
| Atrioventricular Block | 2/1441 (0.1%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Atrioventricular Block Complete | 2/1441 (0.1%) | 2/1445 (0.1%) | 3/1441 (0.2%) | |||
| Atrioventricular Block Second Degree | 3/1441 (0.2%) | 2/1445 (0.1%) | 2/1441 (0.1%) | |||
| Bradycardia | 4/1441 (0.3%) | 2/1445 (0.1%) | 5/1441 (0.3%) | |||
| Cardiac Arrest | 6/1441 (0.4%) | 7/1445 (0.5%) | 6/1441 (0.4%) | |||
| Cardiac Disorder | 0/1441 (0%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Cardiac Failure | 19/1441 (1.3%) | 19/1445 (1.3%) | 23/1441 (1.6%) | |||
| Cardiac Failure Acute | 2/1441 (0.1%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Cardiac Failure Chronic | 5/1441 (0.3%) | 3/1445 (0.2%) | 2/1441 (0.1%) | |||
| Cardiac Failure Congestive | 20/1441 (1.4%) | 15/1445 (1%) | 14/1441 (1%) | |||
| Cardio-Respiratory Arrest | 2/1441 (0.1%) | 3/1445 (0.2%) | 1/1441 (0.1%) | |||
| Cardiogenic Shock | 0/1441 (0%) | 2/1445 (0.1%) | 4/1441 (0.3%) | |||
| Cardiomyopathy | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Cardiopulmonary Failure | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Cardiovascular Disorder | 1/1441 (0.1%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Cor Pulmonale | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Coronary Artery Disease | 24/1441 (1.7%) | 24/1445 (1.7%) | 23/1441 (1.6%) | |||
| Coronary Artery Insufficiency | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Coronary Artery Occlusion | 2/1441 (0.1%) | 2/1445 (0.1%) | 0/1441 (0%) | |||
| Coronary Artery Stenosis | 5/1441 (0.3%) | 5/1445 (0.3%) | 7/1441 (0.5%) | |||
| Coronary Artery Thrombosis | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Hypertensive Heart Disease | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Ischaemic Cardiomyopathy | 1/1441 (0.1%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Left Ventricular Dysfunction | 2/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Left Ventricular Failure | 2/1441 (0.1%) | 1/1445 (0.1%) | 2/1441 (0.1%) | |||
| Mitral Valve Incompetence | 1/1441 (0.1%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Myocardial Fibrosis | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Myocardial Infarction | 16/1441 (1.1%) | 18/1445 (1.2%) | 11/1441 (0.8%) | |||
| Myocardial Ischaemia | 9/1441 (0.6%) | 11/1445 (0.8%) | 6/1441 (0.4%) | |||
| Palpitations | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Pericardial Effusion | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Pericarditis Constrictive | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Pulseless Electrical Activity | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Restrictive Cardiomyopathy | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Right Ventricular Failure | 0/1441 (0%) | 2/1445 (0.1%) | 0/1441 (0%) | |||
| Sinus Bradycardia | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Sinus Node Dysfunction | 2/1441 (0.1%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Supraventricular Tachycardia | 6/1441 (0.4%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Tachycardia | 1/1441 (0.1%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Ventricular Arrhythmia | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Ventricular Extrasystoles | 2/1441 (0.1%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Ventricular Fibrillation | 3/1441 (0.2%) | 2/1445 (0.1%) | 1/1441 (0.1%) | |||
| Ventricular Tachycardia | 3/1441 (0.2%) | 2/1445 (0.1%) | 3/1441 (0.2%) | |||
| Congenital, familial and genetic disorders | ||||||
| Arteriovenous Malformation | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Developmental Hip Dysplasia | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Hydrocele | 1/1441 (0.1%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Phimosis | 0/1441 (0%) | 2/1445 (0.1%) | 4/1441 (0.3%) | |||
| Vitello-Intestinal Duct Remnant | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Ear and labyrinth disorders | ||||||
| Deafness Neurosensory | 1/1441 (0.1%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Hypoacusis | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Vertigo | 2/1441 (0.1%) | 2/1445 (0.1%) | 3/1441 (0.2%) | |||
| Vertigo Positional | 2/1441 (0.1%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Endocrine disorders | ||||||
| Empty Sella Syndrome | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Goitre | 1/1441 (0.1%) | 0/1445 (0%) | 2/1441 (0.1%) | |||
| Hyperparathyroidism | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Hyperparathyroidism Primary | 0/1441 (0%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Inappropriate Antidiuretic Hormone Secretion | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Thyroiditis | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Eye disorders | ||||||
| Amaurosis Fugax | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Blindness Unilateral | 1/1441 (0.1%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Cataract | 8/1441 (0.6%) | 8/1445 (0.6%) | 10/1441 (0.7%) | |||
| Cataract Diabetic | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Cataract Nuclear | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Cataract Subcapsular | 2/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Dacryostenosis Acquired | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Diabetic Retinopathy | 1/1441 (0.1%) | 3/1445 (0.2%) | 2/1441 (0.1%) | |||
| Diplopia | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Exophthalmos | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Eye Haemorrhage | 1/1441 (0.1%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Eyelid Ptosis | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Glaucoma | 2/1441 (0.1%) | 0/1445 (0%) | 3/1441 (0.2%) | |||
| Lens Dislocation | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Macular Degeneration | 0/1441 (0%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Macular Fibrosis | 1/1441 (0.1%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Macular Hole | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Maculopathy | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Ocular Myasthenia | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Open Angle Glaucoma | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Optic Ischaemic Neuropathy | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Retinal Detachment | 2/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Retinal Vascular Thrombosis | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Retinopathy Proliferative | 0/1441 (0%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Ulcerative Keratitis | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Visual Impairment | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Vitreous Floaters | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Vitreous Haemorrhage | 0/1441 (0%) | 2/1445 (0.1%) | 1/1441 (0.1%) | |||
| Gastrointestinal disorders | ||||||
| Abdominal Hernia | 3/1441 (0.2%) | 2/1445 (0.1%) | 5/1441 (0.3%) | |||
| Abdominal Incarcerated Hernia | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Abdominal Pain | 4/1441 (0.3%) | 3/1445 (0.2%) | 5/1441 (0.3%) | |||
| Abdominal Pain Upper | 0/1441 (0%) | 2/1445 (0.1%) | 0/1441 (0%) | |||
| Abdominal Wall Haematoma | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Anal Fissure | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Anal Fistula | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Ascites | 1/1441 (0.1%) | 1/1445 (0.1%) | 3/1441 (0.2%) | |||
| Bowel Movement Irregularity | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Chronic Gastritis | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Colitis | 1/1441 (0.1%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Colitis Ischaemic | 1/1441 (0.1%) | 2/1445 (0.1%) | 0/1441 (0%) | |||
| Colitis Microscopic | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Colitis Ulcerative | 0/1441 (0%) | 2/1445 (0.1%) | 0/1441 (0%) | |||
| Colon Dysplasia | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Colonic Pseudo-Obstruction | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Constipation | 2/1441 (0.1%) | 2/1445 (0.1%) | 0/1441 (0%) | |||
| Diarrhoea | 3/1441 (0.2%) | 3/1445 (0.2%) | 1/1441 (0.1%) | |||
| Dieulafoy's Vascular Malformation | 0/1441 (0%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Diverticulum Intestinal | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Diverticulum Intestinal Haemorrhagic | 0/1441 (0%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Duodenal Ulcer | 4/1441 (0.3%) | 0/1445 (0%) | 2/1441 (0.1%) | |||
| Dyspepsia | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Dysphagia | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Enteritis | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Erosive Duodenitis | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Eructation | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Food Poisoning | 1/1441 (0.1%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Gallstone Ileus | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Gastric Mucosal Hypertrophy | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Gastric Perforation | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Gastric Ulcer | 1/1441 (0.1%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Gastric Ulcer Perforation | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Gastritis | 1/1441 (0.1%) | 2/1445 (0.1%) | 2/1441 (0.1%) | |||
| Gastrointestinal Erosion | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Gastrointestinal Haemorrhage | 2/1441 (0.1%) | 0/1445 (0%) | 4/1441 (0.3%) | |||
| Gastrointestinal Necrosis | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Gastrointestinal Obstruction | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Gastrooesophageal Reflux Disease | 1/1441 (0.1%) | 2/1445 (0.1%) | 1/1441 (0.1%) | |||
| Haematemesis | 1/1441 (0.1%) | 1/1445 (0.1%) | 2/1441 (0.1%) | |||
| Haemorrhoidal Haemorrhage | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Haemorrhoids | 1/1441 (0.1%) | 3/1445 (0.2%) | 0/1441 (0%) | |||
| Hernial Eventration | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Hiatus Hernia | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Ileus | 1/1441 (0.1%) | 3/1445 (0.2%) | 0/1441 (0%) | |||
| Ileus Paralytic | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Incarcerated Umbilical Hernia | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Inguinal Hernia | 0/1441 (0%) | 3/1445 (0.2%) | 0/1441 (0%) | |||
| Intestinal Haemorrhage | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Intestinal Ischaemia | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Intestinal Polyp | 1/1441 (0.1%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Intra-Abdominal Haemorrhage | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Intussusception | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Large Intestine Perforation | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Large Intestine Polyp | 0/1441 (0%) | 2/1445 (0.1%) | 0/1441 (0%) | |||
| Lower Gastrointestinal Haemorrhage | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Mallory-Weiss Syndrome | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Oesophageal Achalasia | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Oesophageal Obstruction | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Oesophageal Ulcer | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Oesophageal Varices Haemorrhage | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Pancreatic Cyst | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Pancreatic Pseudocyst | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Pancreatitis | 1/1441 (0.1%) | 3/1445 (0.2%) | 2/1441 (0.1%) | |||
| Pancreatitis Acute | 1/1441 (0.1%) | 4/1445 (0.3%) | 1/1441 (0.1%) | |||
| Pancreatitis Haemorrhagic | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Pancreatitis Necrotising | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Peptic Ulcer | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Rectal Haemorrhage | 4/1441 (0.3%) | 6/1445 (0.4%) | 3/1441 (0.2%) | |||
| Rectal Ulcer | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Small Intestinal Obstruction | 0/1441 (0%) | 2/1445 (0.1%) | 3/1441 (0.2%) | |||
| Tooth Disorder | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Umbilical Hernia | 3/1441 (0.2%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Upper Gastrointestinal Haemorrhage | 3/1441 (0.2%) | 3/1445 (0.2%) | 1/1441 (0.1%) | |||
| Varices Oesophageal | 1/1441 (0.1%) | 0/1445 (0%) | 2/1441 (0.1%) | |||
| Vomiting | 1/1441 (0.1%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| General disorders | ||||||
| Adverse Drug Reaction | 0/1441 (0%) | 2/1445 (0.1%) | 0/1441 (0%) | |||
| Application Site Dermatitis | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Asthenia | 0/1441 (0%) | 2/1445 (0.1%) | 0/1441 (0%) | |||
| Chest Discomfort | 3/1441 (0.2%) | 3/1445 (0.2%) | 2/1441 (0.1%) | |||
| Chest Pain | 23/1441 (1.6%) | 26/1445 (1.8%) | 13/1441 (0.9%) | |||
| Complication Associated with Device | 0/1441 (0%) | 0/1445 (0%) | 2/1441 (0.1%) | |||
| Death | 8/1441 (0.6%) | 8/1445 (0.6%) | 8/1441 (0.6%) | |||
| Drug Intolerance | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Facial Pain | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Fatigue | 2/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Generalised Oedema | 1/1441 (0.1%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Impaired Healing | 0/1441 (0%) | 2/1445 (0.1%) | 0/1441 (0%) | |||
| Ischaemic Ulcer | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Medical Device Site Reaction | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Multiple Organ Dysfunction Syndrome | 1/1441 (0.1%) | 0/1445 (0%) | 2/1441 (0.1%) | |||
| Necrosis | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Non-Cardiac Chest Pain | 2/1441 (0.1%) | 8/1445 (0.6%) | 5/1441 (0.3%) | |||
| Oedema Peripheral | 3/1441 (0.2%) | 3/1445 (0.2%) | 1/1441 (0.1%) | |||
| Perforated Ulcer | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Peripheral Swelling | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Pyrexia | 3/1441 (0.2%) | 3/1445 (0.2%) | 3/1441 (0.2%) | |||
| Strangulated Hernia | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Sudden Cardiac Death | 5/1441 (0.3%) | 0/1445 (0%) | 9/1441 (0.6%) | |||
| Sudden Death | 6/1441 (0.4%) | 5/1445 (0.3%) | 3/1441 (0.2%) | |||
| Vascular Stent Occlusion | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Vascular Stent Restenosis | 2/1441 (0.1%) | 3/1445 (0.2%) | 1/1441 (0.1%) | |||
| Hepatobiliary disorders | ||||||
| Alcoholic Liver Disease | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Bile Duct Obstruction | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Bile Duct Stone | 1/1441 (0.1%) | 2/1445 (0.1%) | 1/1441 (0.1%) | |||
| Cholangitis | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Cholangitis Acute | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Cholecystitis | 2/1441 (0.1%) | 5/1445 (0.3%) | 5/1441 (0.3%) | |||
| Cholecystitis Acute | 4/1441 (0.3%) | 6/1445 (0.4%) | 3/1441 (0.2%) | |||
| Cholecystitis Chronic | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Cholelithiasis | 11/1441 (0.8%) | 9/1445 (0.6%) | 7/1441 (0.5%) | |||
| Cholestasis | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Drug-Induced Liver Injury | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Gallbladder Disorder | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Gallbladder Pain | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Gallbladder Perforation | 0/1441 (0%) | 2/1445 (0.1%) | 0/1441 (0%) | |||
| Gallbladder Polyp | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Hepatic Cirrhosis | 1/1441 (0.1%) | 0/1445 (0%) | 2/1441 (0.1%) | |||
| Hepatic Failure | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Hepatic Fibrosis | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Hepatic Steatosis | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Hepatomegaly | 1/1441 (0.1%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Hepatorenal Syndrome | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Jaundice Cholestatic | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Liver Disorder | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Non-Alcoholic Steatohepatitis | 0/1441 (0%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Portal Hypertension | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Portal Vein Thrombosis | 2/1441 (0.1%) | 0/1445 (0%) | 2/1441 (0.1%) | |||
| Post Cholecystectomy Syndrome | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Immune system disorders | ||||||
| Atopy | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Drug Hypersensitivity | 1/1441 (0.1%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Food Allergy | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Infections and infestations | ||||||
| Abdominal Abscess | 1/1441 (0.1%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Abdominal Sepsis | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Abscess | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Abscess Limb | 4/1441 (0.3%) | 5/1445 (0.3%) | 2/1441 (0.1%) | |||
| Anal Abscess | 1/1441 (0.1%) | 2/1445 (0.1%) | 0/1441 (0%) | |||
| Appendicitis | 2/1441 (0.1%) | 3/1445 (0.2%) | 6/1441 (0.4%) | |||
| Appendicitis Perforated | 1/1441 (0.1%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Arthritis Bacterial | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Arthritis Infective | 1/1441 (0.1%) | 2/1445 (0.1%) | 1/1441 (0.1%) | |||
| Atypical Pneumonia | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Bacteraemia | 1/1441 (0.1%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Bacterial Sepsis | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Biliary Sepsis | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Bronchitis | 4/1441 (0.3%) | 5/1445 (0.3%) | 3/1441 (0.2%) | |||
| Bronchitis Bacterial | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Bronchopulmonary Aspergillosis | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Burn Infection | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Campylobacter Gastroenteritis | 0/1441 (0%) | 0/1445 (0%) | 2/1441 (0.1%) | |||
| Carbuncle | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Cellulitis | 19/1441 (1.3%) | 15/1445 (1%) | 15/1441 (1%) | |||
| Cellulitis Gangrenous | 0/1441 (0%) | 1/1445 (0.1%) | 2/1441 (0.1%) | |||
| Cellulitis Staphylococcal | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Cholecystitis Infective | 0/1441 (0%) | 0/1445 (0%) | 3/1441 (0.2%) | |||
| Chronic Hepatitis B | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Chronic Sinusitis | 0/1441 (0%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Clostridium Difficile Colitis | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Clostridium Difficile Infection | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Colon Gangrene | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Dengue Fever | 0/1441 (0%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Device Related Infection | 1/1441 (0.1%) | 1/1445 (0.1%) | 2/1441 (0.1%) | |||
| Diabetic Foot Infection | 1/1441 (0.1%) | 2/1445 (0.1%) | 6/1441 (0.4%) | |||
| Diabetic Gangrene | 1/1441 (0.1%) | 2/1445 (0.1%) | 1/1441 (0.1%) | |||
| Diverticulitis | 3/1441 (0.2%) | 3/1445 (0.2%) | 5/1441 (0.3%) | |||
| Endocarditis | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Enterococcal Bacteraemia | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Epiglottitis | 0/1441 (0%) | 0/1445 (0%) | 2/1441 (0.1%) | |||
| Erysipelas | 1/1441 (0.1%) | 3/1445 (0.2%) | 5/1441 (0.3%) | |||
| Escherichia Urinary Tract Infection | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Eye Infection | 1/1441 (0.1%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Eye Infection Fungal | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Gangrene | 4/1441 (0.3%) | 15/1445 (1%) | 6/1441 (0.4%) | |||
| Gastroenteritis | 6/1441 (0.4%) | 5/1445 (0.3%) | 8/1441 (0.6%) | |||
| Gastroenteritis Viral | 0/1441 (0%) | 1/1445 (0.1%) | 2/1441 (0.1%) | |||
| Gastrointestinal Infection | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Groin Abscess | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Groin Infection | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Haematoma Infection | 1/1441 (0.1%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Helicobacter Infection | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Hepatitis C | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Hepatitis E | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Herpes Zoster | 1/1441 (0.1%) | 2/1445 (0.1%) | 1/1441 (0.1%) | |||
| Hiv Infection | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Infected Cyst | 0/1441 (0%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Infected Dermal Cyst | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Infected Skin Ulcer | 2/1441 (0.1%) | 2/1445 (0.1%) | 3/1441 (0.2%) | |||
| Infective Exacerbation of Bronchiectasis | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Influenza | 0/1441 (0%) | 3/1445 (0.2%) | 2/1441 (0.1%) | |||
| Intervertebral Discitis | 0/1441 (0%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Klebsiella Infection | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Laryngitis | 1/1441 (0.1%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Leptospirosis | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Liver Abscess | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Localised Infection | 1/1441 (0.1%) | 4/1445 (0.3%) | 10/1441 (0.7%) | |||
| Lower Respiratory Tract Infection | 7/1441 (0.5%) | 1/1445 (0.1%) | 4/1441 (0.3%) | |||
| Lung Infection | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Lymphangitis | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Malaria | 1/1441 (0.1%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Medical Device Site Infection | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Meningitis | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Meningitis Viral | 0/1441 (0%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Necrotising Fasciitis | 1/1441 (0.1%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Nosocomial Infection | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Oesophageal Candidiasis | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Oral Candidiasis | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Orchitis | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Osteomyelitis | 7/1441 (0.5%) | 11/1445 (0.8%) | 12/1441 (0.8%) | |||
| Osteomyelitis Chronic | 0/1441 (0%) | 0/1445 (0%) | 2/1441 (0.1%) | |||
| Otitis Externa | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Otitis Media | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Paronychia | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Pathogen Resistance | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Pelvic Abscess | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Penile Infection | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Perineal Abscess | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Perinephric Abscess | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Peritonitis | 1/1441 (0.1%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Peritonsillar Abscess | 0/1441 (0%) | 0/1445 (0%) | 2/1441 (0.1%) | |||
| Pharyngitis | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Plasmodium Vivax Infection | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Pneumonia | 36/1441 (2.5%) | 31/1445 (2.1%) | 26/1441 (1.8%) | |||
| Pneumonia Bacterial | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Pneumonia Influenzal | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Post Procedural Cellulitis | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Post Procedural Infection | 1/1441 (0.1%) | 2/1445 (0.1%) | 3/1441 (0.2%) | |||
| Postoperative Abscess | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Postoperative Wound Infection | 5/1441 (0.3%) | 2/1445 (0.1%) | 4/1441 (0.3%) | |||
| Pseudomonal Bacteraemia | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Psoas Abscess | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Pulmonary Sepsis | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Pulmonary Tuberculosis | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Pyelonephritis | 3/1441 (0.2%) | 3/1445 (0.2%) | 0/1441 (0%) | |||
| Pyelonephritis Acute | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Pyelonephritis Chronic | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Pyoderma | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Renal Tuberculosis | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Respiratory Tract Infection | 3/1441 (0.2%) | 2/1445 (0.1%) | 0/1441 (0%) | |||
| Respiratory Tract Infection Viral | 1/1441 (0.1%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Sepsis | 10/1441 (0.7%) | 12/1445 (0.8%) | 4/1441 (0.3%) | |||
| Septic Shock | 3/1441 (0.2%) | 0/1445 (0%) | 2/1441 (0.1%) | |||
| Sialoadenitis | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Sinusitis | 1/1441 (0.1%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Soft Tissue Infection | 0/1441 (0%) | 2/1445 (0.1%) | 1/1441 (0.1%) | |||
| Staphylococcal Abscess | 0/1441 (0%) | 0/1445 (0%) | 2/1441 (0.1%) | |||
| Staphylococcal Infection | 0/1441 (0%) | 2/1445 (0.1%) | 1/1441 (0.1%) | |||
| Staphylococcal Osteomyelitis | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Staphylococcal Sepsis | 0/1441 (0%) | 2/1445 (0.1%) | 2/1441 (0.1%) | |||
| Streptococcal Bacteraemia | 2/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Streptococcal Infection | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Streptococcal Sepsis | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Subcutaneous Abscess | 0/1441 (0%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Superinfection Bacterial | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Testicular Abscess | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Tooth Infection | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Tracheobronchitis | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Typhoid Fever | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Upper Respiratory Tract Infection | 2/1441 (0.1%) | 1/1445 (0.1%) | 2/1441 (0.1%) | |||
| Urinary Tract Infection | 16/1441 (1.1%) | 15/1445 (1%) | 6/1441 (0.4%) | |||
| Urosepsis | 4/1441 (0.3%) | 7/1445 (0.5%) | 3/1441 (0.2%) | |||
| Vestibular Neuronitis | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Viral Infection | 1/1441 (0.1%) | 3/1445 (0.2%) | 2/1441 (0.1%) | |||
| Viral Pharyngitis | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Viral Upper Respiratory Tract Infection | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Vulval Abscess | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Wound Abscess | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Wound Infection | 2/1441 (0.1%) | 0/1445 (0%) | 3/1441 (0.2%) | |||
| Injury, poisoning and procedural complications | ||||||
| Accident | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Accidental Overdose | 1/1441 (0.1%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Acetabulum Fracture | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Alcohol Poisoning | 3/1441 (0.2%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Anaesthetic Complication | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Animal Bite | 1/1441 (0.1%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Ankle Fracture | 0/1441 (0%) | 6/1445 (0.4%) | 5/1441 (0.3%) | |||
| Arterial Bypass Occlusion | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Arterial Bypass Stenosis | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Bone Contusion | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Brain Contusion | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Cervical Vertebral Fracture | 1/1441 (0.1%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Clavicle Fracture | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Concussion | 2/1441 (0.1%) | 1/1445 (0.1%) | 2/1441 (0.1%) | |||
| Contusion | 2/1441 (0.1%) | 2/1445 (0.1%) | 1/1441 (0.1%) | |||
| Coronary Artery Restenosis | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Craniocerebral Injury | 0/1441 (0%) | 1/1445 (0.1%) | 3/1441 (0.2%) | |||
| Dural Tear | 0/1441 (0%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Facial Bones Fracture | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Fall | 0/1441 (0%) | 0/1445 (0%) | 2/1441 (0.1%) | |||
| Femoral Neck Fracture | 0/1441 (0%) | 4/1445 (0.3%) | 4/1441 (0.3%) | |||
| Femur Fracture | 1/1441 (0.1%) | 1/1445 (0.1%) | 7/1441 (0.5%) | |||
| Fibula Fracture | 0/1441 (0%) | 2/1445 (0.1%) | 0/1441 (0%) | |||
| Foot Fracture | 0/1441 (0%) | 0/1445 (0%) | 2/1441 (0.1%) | |||
| Foreign Body | 1/1441 (0.1%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Foreign Body in Eye | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Fracture Displacement | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Head Injury | 1/1441 (0.1%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Heat Stroke | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Hip Fracture | 3/1441 (0.2%) | 4/1445 (0.3%) | 7/1441 (0.5%) | |||
| Humerus Fracture | 2/1441 (0.1%) | 4/1445 (0.3%) | 8/1441 (0.6%) | |||
| Joint Dislocation | 2/1441 (0.1%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Joint Injury | 0/1441 (0%) | 2/1445 (0.1%) | 0/1441 (0%) | |||
| Laceration | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Ligament Rupture | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Ligament Sprain | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Limb Injury | 0/1441 (0%) | 1/1445 (0.1%) | 2/1441 (0.1%) | |||
| Lower Limb Fracture | 2/1441 (0.1%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Lumbar Vertebral Fracture | 0/1441 (0%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Meniscus Injury | 1/1441 (0.1%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Multiple Injuries | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Muscle Rupture | 1/1441 (0.1%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Overdose | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Patella Fracture | 0/1441 (0%) | 2/1445 (0.1%) | 1/1441 (0.1%) | |||
| Pelvic Fracture | 1/1441 (0.1%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Peripheral Artery Restenosis | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Post Concussion Syndrome | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Post Procedural Bile Leak | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Post Procedural Complication | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Post Procedural Haemorrhage | 0/1441 (0%) | 1/1445 (0.1%) | 2/1441 (0.1%) | |||
| Postoperative Renal Failure | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Postoperative Respiratory Failure | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Postoperative Thoracic Procedure Complication | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Postoperative Wound Complication | 0/1441 (0%) | 0/1445 (0%) | 2/1441 (0.1%) | |||
| Procedural Haemorrhage | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Procedural Nausea | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Procedural Pain | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Procedural Vomiting | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Pubis Fracture | 0/1441 (0%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Radius Fracture | 0/1441 (0%) | 2/1445 (0.1%) | 1/1441 (0.1%) | |||
| Rib Fracture | 1/1441 (0.1%) | 3/1445 (0.2%) | 8/1441 (0.6%) | |||
| Road Traffic Accident | 2/1441 (0.1%) | 1/1445 (0.1%) | 2/1441 (0.1%) | |||
| Skin Injury | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Skull Fracture | 0/1441 (0%) | 0/1445 (0%) | 3/1441 (0.2%) | |||
| Skull Fractured Base | 0/1441 (0%) | 1/1445 (0.1%) | 2/1441 (0.1%) | |||
| Spinal Compression Fracture | 1/1441 (0.1%) | 0/1445 (0%) | 2/1441 (0.1%) | |||
| Spinal Cord Injury | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Spinal Fracture | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Sternal Fracture | 0/1441 (0%) | 2/1445 (0.1%) | 0/1441 (0%) | |||
| Stomal Hernia | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Subarachnoid Haemorrhage | 1/1441 (0.1%) | 0/1445 (0%) | 2/1441 (0.1%) | |||
| Subcutaneous Haematoma | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Subdural Haematoma | 0/1441 (0%) | 1/1445 (0.1%) | 2/1441 (0.1%) | |||
| Subdural Haemorrhage | 0/1441 (0%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Tendon Injury | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Tendon Rupture | 2/1441 (0.1%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Thermal Burn | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Thoracic Vertebral Fracture | 0/1441 (0%) | 2/1445 (0.1%) | 0/1441 (0%) | |||
| Tibia Fracture | 0/1441 (0%) | 4/1445 (0.3%) | 1/1441 (0.1%) | |||
| Traumatic Haematoma | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Traumatic Intracranial Haemorrhage | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Ulna Fracture | 0/1441 (0%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Upper Limb Fracture | 3/1441 (0.2%) | 2/1445 (0.1%) | 1/1441 (0.1%) | |||
| Urinary Retention Postoperative | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Vascular Graft Complication | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Vascular Pseudoaneurysm | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Wound | 2/1441 (0.1%) | 2/1445 (0.1%) | 2/1441 (0.1%) | |||
| Wound Complication | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Wound Necrosis | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Wrist Fracture | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Investigations | ||||||
| Alanine Aminotransferase Increased | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Blood Creatinine Increased | 1/1441 (0.1%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Blood Glucose Abnormal | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Blood Glucose Increased | 0/1441 (0%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Blood Pressure Abnormal | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Blood Pressure Decreased | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Blood Pressure Increased | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Cardiac Stress Test Abnormal | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Catheterisation Cardiac | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Clostridium Test Positive | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Colonoscopy | 1/1441 (0.1%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Electrocardiogram Abnormal | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Electrocardiogram St Segment Depression | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Electrocardiogram St-T Segment Abnormal | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Exercise Test Abnormal | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Gamma-Glutamyltransferase Increased | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Glomerular Filtration Rate Decreased | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Hepatic Enzyme Increased | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Intraocular Pressure Increased | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Liver Function Test Increased | 0/1441 (0%) | 2/1445 (0.1%) | 0/1441 (0%) | |||
| Precancerous Cells Present | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Renal Function Test Abnormal | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Troponin Increased | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Weight Decreased | 3/1441 (0.2%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Metabolism and nutrition disorders | ||||||
| Acidosis | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Decreased Appetite | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Dehydration | 4/1441 (0.3%) | 1/1445 (0.1%) | 4/1441 (0.3%) | |||
| Diabetes Mellitus | 10/1441 (0.7%) | 6/1445 (0.4%) | 6/1441 (0.4%) | |||
| Diabetes Mellitus Inadequate Control | 7/1441 (0.5%) | 3/1445 (0.2%) | 3/1441 (0.2%) | |||
| Diabetic Ketoacidosis | 1/1441 (0.1%) | 4/1445 (0.3%) | 3/1441 (0.2%) | |||
| Fluid Overload | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Gout | 1/1441 (0.1%) | 0/1445 (0%) | 4/1441 (0.3%) | |||
| Hypercalcaemia | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Hyperglycaemia | 6/1441 (0.4%) | 1/1445 (0.1%) | 6/1441 (0.4%) | |||
| Hyperkalaemia | 2/1441 (0.1%) | 3/1445 (0.2%) | 3/1441 (0.2%) | |||
| Hyperosmolar Hyperglycaemic State | 0/1441 (0%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Hypoglycaemia | 8/1441 (0.6%) | 12/1445 (0.8%) | 12/1441 (0.8%) | |||
| Hypokalaemia | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Hyponatraemia | 3/1441 (0.2%) | 3/1445 (0.2%) | 0/1441 (0%) | |||
| Hypoproteinaemia | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Hypovolaemia | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Ketoacidosis | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Ketosis | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Lactic Acidosis | 1/1441 (0.1%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Metabolic Acidosis | 2/1441 (0.1%) | 1/1445 (0.1%) | 2/1441 (0.1%) | |||
| Metabolic Disorder | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Metabolic Syndrome | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Obesity | 3/1441 (0.2%) | 5/1445 (0.3%) | 0/1441 (0%) | |||
| Type 2 Diabetes Mellitus | 0/1441 (0%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Vitamin B12 Deficiency | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Acquired Claw Toe | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Ankylosing Spondylitis | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Arthralgia | 3/1441 (0.2%) | 5/1445 (0.3%) | 2/1441 (0.1%) | |||
| Arthritis | 2/1441 (0.1%) | 3/1445 (0.2%) | 1/1441 (0.1%) | |||
| Arthropathy | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Back Pain | 3/1441 (0.2%) | 5/1445 (0.3%) | 4/1441 (0.3%) | |||
| Bone Atrophy | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Bone Cyst | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Bursitis | 0/1441 (0%) | 0/1445 (0%) | 3/1441 (0.2%) | |||
| Chondromalacia | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Chondropathy | 0/1441 (0%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Costochondritis | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Diabetic Arthropathy | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Dupuytren's Contracture | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Exostosis | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Flank Pain | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Foot Deformity | 1/1441 (0.1%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Gouty Arthritis | 2/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Gouty Tophus | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Haemarthrosis | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Intervertebral Disc Compression | 0/1441 (0%) | 0/1445 (0%) | 2/1441 (0.1%) | |||
| Intervertebral Disc Degeneration | 0/1441 (0%) | 2/1445 (0.1%) | 0/1441 (0%) | |||
| Intervertebral Disc Disorder | 2/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Intervertebral Disc Protrusion | 4/1441 (0.3%) | 3/1445 (0.2%) | 6/1441 (0.4%) | |||
| Juvenile Idiopathic Arthritis | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Lumbar Spinal Stenosis | 0/1441 (0%) | 8/1445 (0.6%) | 3/1441 (0.2%) | |||
| Lupus-Like Syndrome | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Muscle Atrophy | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Musculoskeletal Chest Pain | 1/1441 (0.1%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Musculoskeletal Pain | 0/1441 (0%) | 1/1445 (0.1%) | 2/1441 (0.1%) | |||
| Myalgia | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Neck Pain | 1/1441 (0.1%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Neuropathic Arthropathy | 0/1441 (0%) | 2/1445 (0.1%) | 1/1441 (0.1%) | |||
| Osteitis | 0/1441 (0%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Osteoarthritis | 27/1441 (1.9%) | 30/1445 (2.1%) | 23/1441 (1.6%) | |||
| Osteochondrosis | 1/1441 (0.1%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Osteonecrosis | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Pain in Extremity | 4/1441 (0.3%) | 3/1445 (0.2%) | 1/1441 (0.1%) | |||
| Periarthritis | 0/1441 (0%) | 3/1445 (0.2%) | 0/1441 (0%) | |||
| Polyarthritis | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Polymyalgia Rheumatica | 2/1441 (0.1%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Psoriatic Arthropathy | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Rotator Cuff Syndrome | 2/1441 (0.1%) | 2/1445 (0.1%) | 2/1441 (0.1%) | |||
| Senile Osteoporosis | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Spinal Column Stenosis | 6/1441 (0.4%) | 4/1445 (0.3%) | 3/1441 (0.2%) | |||
| Spinal Osteoarthritis | 4/1441 (0.3%) | 3/1445 (0.2%) | 1/1441 (0.1%) | |||
| Spinal Pain | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Spondyloarthropathy | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Spondylolisthesis | 2/1441 (0.1%) | 2/1445 (0.1%) | 0/1441 (0%) | |||
| Synovial Cyst | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Tendon Disorder | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Tendonitis | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Tenosynovitis | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Vertebral Foraminal Stenosis | 0/1441 (0%) | 0/1445 (0%) | 2/1441 (0.1%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Acute Leukaemia | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Adenocarcinoma Gastric | 0/1441 (0%) | 0/1445 (0%) | 4/1441 (0.3%) | |||
| Adenocarcinoma of Colon | 2/1441 (0.1%) | 3/1445 (0.2%) | 1/1441 (0.1%) | |||
| Adenolymphoma | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Adenosquamous Cell Lung Cancer | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Adrenal Adenoma | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Anal Squamous Cell Carcinoma | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Appendix Adenoma | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Basal Cell Carcinoma | 2/1441 (0.1%) | 3/1445 (0.2%) | 2/1441 (0.1%) | |||
| Benign Neoplasm of Bladder | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Benign Neoplasm of Prostate | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Benign Peritoneal Neoplasm | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Bile Duct Cancer | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Bladder Cancer | 5/1441 (0.3%) | 4/1445 (0.3%) | 0/1441 (0%) | |||
| Bladder Cancer Stage 0, with Cancer in Situ | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Bladder Papilloma | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Bladder Transitional Cell Carcinoma | 2/1441 (0.1%) | 1/1445 (0.1%) | 2/1441 (0.1%) | |||
| Breast Cancer | 3/1441 (0.2%) | 3/1445 (0.2%) | 6/1441 (0.4%) | |||
| Breast Cancer Recurrent | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Breast Cancer Stage I | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Bronchial Carcinoma | 2/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Bronchial Neoplasm Benign | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Carcinoid Tumour Pulmonary | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Carcinoid Tumour of the Duodenum | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Carotid Body Tumour | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Cholangiocarcinoma | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Chondrosarcoma | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Chondrosarcoma Metastatic | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Chronic Myeloid Leukaemia | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Chronic Myelomonocytic Leukaemia | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Clear Cell Renal Cell Carcinoma | 1/1441 (0.1%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Colon Adenoma | 0/1441 (0%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Colon Cancer | 4/1441 (0.3%) | 1/1445 (0.1%) | 3/1441 (0.2%) | |||
| Colon Cancer Metastatic | 0/1441 (0%) | 0/1445 (0%) | 4/1441 (0.3%) | |||
| Colon Cancer Stage Iii | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Colorectal Cancer | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Diffuse Large B-Cell Lymphoma | 0/1441 (0%) | 2/1445 (0.1%) | 0/1441 (0%) | |||
| Endometrial Adenocarcinoma | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Endometrial Cancer | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Gallbladder Cancer | 0/1441 (0%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Gallbladder Cancer Metastatic | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Gastric Cancer | 2/1441 (0.1%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Gastrointestinal Tract Adenoma | 1/1441 (0.1%) | 2/1445 (0.1%) | 1/1441 (0.1%) | |||
| Head and Neck Cancer | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Hepatic Cancer | 0/1441 (0%) | 3/1445 (0.2%) | 1/1441 (0.1%) | |||
| Hepatic Cancer Metastatic | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Hepatocellular Carcinoma | 3/1441 (0.2%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Hodgkin's Disease | 1/1441 (0.1%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Invasive Ductal Breast Carcinoma | 2/1441 (0.1%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Kidney Angiomyolipoma | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Large Cell Lung Cancer | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Large Intestine Benign Neoplasm | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Laryngeal Squamous Cell Carcinoma | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Lentigo Maligna | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Lipoma | 2/1441 (0.1%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Lung Adenocarcinoma | 1/1441 (0.1%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Lung Adenocarcinoma Metastatic | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Lung Cancer Metastatic | 2/1441 (0.1%) | 1/1445 (0.1%) | 2/1441 (0.1%) | |||
| Lung Neoplasm Malignant | 4/1441 (0.3%) | 3/1445 (0.2%) | 4/1441 (0.3%) | |||
| Lung Squamous Cell Carcinoma Stage 0 | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Lymphocytic Lymphoma | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Lymphoma | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Malignant Melanoma | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Malignant Melanoma in Situ | 0/1441 (0%) | 0/1445 (0%) | 2/1441 (0.1%) | |||
| Melanocytic Naevus | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Meningioma | 0/1441 (0%) | 2/1445 (0.1%) | 1/1441 (0.1%) | |||
| Metastases to Bone | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Metastases to Central Nervous System | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Metastases to Lymph Nodes | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Metastases to Peritoneum | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Metastases to Small Intestine | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Metastatic Carcinoid Tumour | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Metastatic Carcinoma of the Bladder | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Metastatic Malignant Melanoma | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Metastatic Renal Cell Carcinoma | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Monoclonal Gammopathy | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Myelodysplastic Syndrome | 0/1441 (0%) | 1/1445 (0.1%) | 2/1441 (0.1%) | |||
| Myeloid Leukaemia | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Myeloproliferative Neoplasm | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Neuroendocrine Carcinoma Metastatic | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Neuroendocrine Carcinoma of the Skin | 0/1441 (0%) | 0/1445 (0%) | 2/1441 (0.1%) | |||
| Non-Small Cell Lung Cancer | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Non-Small Cell Lung Cancer Stage Iv | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Oesophageal Adenocarcinoma | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Ovarian Cancer | 1/1441 (0.1%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Ovarian Cancer Metastatic | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Pancreatic Carcinoma | 3/1441 (0.2%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Pancreatic Carcinoma Metastatic | 1/1441 (0.1%) | 1/1445 (0.1%) | 2/1441 (0.1%) | |||
| Pancreatic Neoplasm | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Papillary Serous Endometrial Carcinoma | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Papillary Thyroid Cancer | 0/1441 (0%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Paraneoplastic Syndrome | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Parathyroid Tumour Benign | 0/1441 (0%) | 1/1445 (0.1%) | 3/1441 (0.2%) | |||
| Penile Cancer | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Prostate Cancer | 7/1441 (0.5%) | 8/1445 (0.6%) | 6/1441 (0.4%) | |||
| Prostate Cancer Metastatic | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Prostate Cancer Recurrent | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Prostatic Adenoma | 1/1441 (0.1%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Rectal Adenocarcinoma | 1/1441 (0.1%) | 2/1445 (0.1%) | 3/1441 (0.2%) | |||
| Rectal Adenoma | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Rectal Cancer | 1/1441 (0.1%) | 2/1445 (0.1%) | 1/1441 (0.1%) | |||
| Rectal Cancer Recurrent | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Rectosigmoid Cancer | 0/1441 (0%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Renal Cancer | 0/1441 (0%) | 2/1445 (0.1%) | 2/1441 (0.1%) | |||
| Renal Cancer Metastatic | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Renal Cancer Stage I | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Renal Cell Carcinoma | 0/1441 (0%) | 2/1445 (0.1%) | 1/1441 (0.1%) | |||
| Renal Cell Carcinoma Stage Ii | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Renal Neoplasm | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Renal Oncocytoma | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Sarcoma Uterus | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Seminoma | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Skin Cancer | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Squamous Cell Carcinoma | 2/1441 (0.1%) | 1/1445 (0.1%) | 2/1441 (0.1%) | |||
| Squamous Cell Carcinoma of Skin | 1/1441 (0.1%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Squamous Cell Carcinoma of the Oral Cavity | 1/1441 (0.1%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Squamous Cell Carcinoma of the Tongue | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Superficial Spreading Melanoma Stage Unspecified | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Testicular Seminoma (Pure) | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Throat Cancer | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Thyroid Adenoma | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Thyroid Cancer | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Tonsil Cancer | 0/1441 (0%) | 1/1445 (0.1%) | 2/1441 (0.1%) | |||
| Transitional Cell Cancer of the Renal Pelvis and Ureter | 0/1441 (0%) | 2/1445 (0.1%) | 0/1441 (0%) | |||
| Transitional Cell Carcinoma | 0/1441 (0%) | 1/1445 (0.1%) | 2/1441 (0.1%) | |||
| Uterine Cancer | 0/1441 (0%) | 1/1445 (0.1%) | 2/1441 (0.1%) | |||
| Uterine Leiomyoma | 1/1441 (0.1%) | 0/1445 (0%) | 2/1441 (0.1%) | |||
| Vulvovaginal Warts | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Nervous system disorders | ||||||
| Alcoholic Seizure | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Amyotrophic Lateral Sclerosis | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Aphasia | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Ataxia | 1/1441 (0.1%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Basal Ganglia Infarction | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Basilar Artery Occlusion | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Brain Injury | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Brain Stem Haemorrhage | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Brain Stem Infarction | 0/1441 (0%) | 0/1445 (0%) | 2/1441 (0.1%) | |||
| Carotid Arteriosclerosis | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Carotid Artery Stenosis | 5/1441 (0.3%) | 5/1445 (0.3%) | 11/1441 (0.8%) | |||
| Carotid Sinus Syndrome | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Carpal Tunnel Syndrome | 2/1441 (0.1%) | 2/1445 (0.1%) | 2/1441 (0.1%) | |||
| Cerebellar Ataxia | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Cerebellar Infarction | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Cerebral Arteriosclerosis | 2/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Cerebral Haemorrhage | 1/1441 (0.1%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Cerebral Infarction | 3/1441 (0.2%) | 2/1445 (0.1%) | 2/1441 (0.1%) | |||
| Cerebrovascular Accident | 10/1441 (0.7%) | 13/1445 (0.9%) | 13/1441 (0.9%) | |||
| Cervicobrachial Syndrome | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Coma | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Cubital Tunnel Syndrome | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Depressed Level of Consciousness | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Diabetic Coma | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Diabetic Hyperosmolar Coma | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Diabetic Neuropathy | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Dizziness | 0/1441 (0%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Encephalopathy | 2/1441 (0.1%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Epilepsy | 1/1441 (0.1%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Facial Paralysis | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Facial Paresis | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Generalised Tonic-Clonic Seizure | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Guillain-Barre Syndrome | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Haemorrhage Intracranial | 0/1441 (0%) | 2/1445 (0.1%) | 0/1441 (0%) | |||
| Haemorrhagic Stroke | 1/1441 (0.1%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Headache | 1/1441 (0.1%) | 2/1445 (0.1%) | 0/1441 (0%) | |||
| Hemiparesis | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Hepatic Encephalopathy | 0/1441 (0%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Hypoglycaemic Coma | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Hyponatraemic Encephalopathy | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Intercostal Neuralgia | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Intracranial Haematoma | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Ischaemic Stroke | 4/1441 (0.3%) | 3/1445 (0.2%) | 2/1441 (0.1%) | |||
| Lacunar Infarction | 0/1441 (0%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Lacunar Stroke | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Loss of Consciousness | 2/1441 (0.1%) | 1/1445 (0.1%) | 2/1441 (0.1%) | |||
| Lumbar Radiculopathy | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Lumbosacral Radiculopathy | 0/1441 (0%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Mental Impairment | 0/1441 (0%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Migraine | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Motor Dysfunction | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Myasthenia Gravis | 0/1441 (0%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Neuralgia | 0/1441 (0%) | 2/1445 (0.1%) | 1/1441 (0.1%) | |||
| Orthostatic Intolerance | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Paraesthesia | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Paralysis Recurrent Laryngeal Nerve | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Parkinson's Disease | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Parkinsonism | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Partial Seizures | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Petit Mal Epilepsy | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Post Herpetic Neuralgia | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Presyncope | 1/1441 (0.1%) | 2/1445 (0.1%) | 3/1441 (0.2%) | |||
| Radiculopathy | 0/1441 (0%) | 1/1445 (0.1%) | 2/1441 (0.1%) | |||
| Reversible Cerebral Vasoconstriction Syndrome | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Sciatica | 0/1441 (0%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Seizure | 2/1441 (0.1%) | 2/1445 (0.1%) | 1/1441 (0.1%) | |||
| Serotonin Syndrome | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Somnolence | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Spinal Claudication | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Spinal Cord Compression | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Syncope | 7/1441 (0.5%) | 9/1445 (0.6%) | 5/1441 (0.3%) | |||
| Transient Ischaemic Attack | 15/1441 (1%) | 7/1445 (0.5%) | 16/1441 (1.1%) | |||
| Trigeminal Neuralgia | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Vascular Encephalopathy | 0/1441 (0%) | 0/1445 (0%) | 2/1441 (0.1%) | |||
| Vertebrobasilar Insufficiency | 3/1441 (0.2%) | 2/1445 (0.1%) | 1/1441 (0.1%) | |||
| Vertigo CNS Origin | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Vith Nerve Paralysis | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Vocal Cord Paralysis | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Product Issues | ||||||
| Device Breakage | 0/1441 (0%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Device Damage | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Psychiatric disorders | ||||||
| Affective Disorder | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Alcoholism | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Anxiety | 0/1441 (0%) | 2/1445 (0.1%) | 0/1441 (0%) | |||
| Completed Suicide | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Confusional State | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Delirium | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Delirium Tremens | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Depression | 1/1441 (0.1%) | 1/1445 (0.1%) | 2/1441 (0.1%) | |||
| Hallucination | 1/1441 (0.1%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Hallucination, Visual | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Insomnia | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Major Depression | 1/1441 (0.1%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Mental Disorder | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Mental Status Changes | 4/1441 (0.3%) | 2/1445 (0.1%) | 1/1441 (0.1%) | |||
| Paranoia | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Schizoaffective Disorder | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Schizophrenia | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Suicide Attempt | 1/1441 (0.1%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Vascular Cognitive Impairment | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Renal and urinary disorders | ||||||
| Acute Kidney Injury | 13/1441 (0.9%) | 15/1445 (1%) | 8/1441 (0.6%) | |||
| Azotaemia | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Bladder Neck Obstruction | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Bladder Prolapse | 0/1441 (0%) | 0/1445 (0%) | 2/1441 (0.1%) | |||
| Bladder Stenosis | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Calculus Bladder | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Calculus Urinary | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Chronic Kidney Disease | 2/1441 (0.1%) | 0/1445 (0%) | 2/1441 (0.1%) | |||
| Cystitis Haemorrhagic | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Diabetic Nephropathy | 0/1441 (0%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Dysuria | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Haematuria | 2/1441 (0.1%) | 2/1445 (0.1%) | 4/1441 (0.3%) | |||
| Hydronephrosis | 1/1441 (0.1%) | 2/1445 (0.1%) | 2/1441 (0.1%) | |||
| Nephrolithiasis | 7/1441 (0.5%) | 2/1445 (0.1%) | 2/1441 (0.1%) | |||
| Oliguria | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Renal Artery Stenosis | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Renal Colic | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Renal Failure | 2/1441 (0.1%) | 2/1445 (0.1%) | 0/1441 (0%) | |||
| Renal Impairment | 1/1441 (0.1%) | 6/1445 (0.4%) | 3/1441 (0.2%) | |||
| Renal Papillary Necrosis | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Renal Tubular Necrosis | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Stress Urinary Incontinence | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Terminal Dribbling | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Tubulointerstitial Nephritis | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Ureteric Obstruction | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Ureterolithiasis | 1/1441 (0.1%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Urethral Meatus Stenosis | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Urethral Stenosis | 0/1441 (0%) | 1/1445 (0.1%) | 4/1441 (0.3%) | |||
| Urinary Bladder Polyp | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Urinary Incontinence | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Urinary Retention | 2/1441 (0.1%) | 0/1445 (0%) | 3/1441 (0.2%) | |||
| Urinary Tract Obstruction | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Reproductive system and breast disorders | ||||||
| Acquired Phimosis | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Adenomyosis | 0/1441 (0%) | 0/1445 (0%) | 2/1441 (0.1%) | |||
| Benign Prostatic Hyperplasia | 1/1441 (0.1%) | 8/1445 (0.6%) | 15/1441 (1%) | |||
| Cervical Dysplasia | 0/1441 (0%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Cystocele | 0/1441 (0%) | 0/1445 (0%) | 2/1441 (0.1%) | |||
| Endometrial Hyperplasia | 1/1441 (0.1%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Epididymal Cyst | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Erectile Dysfunction | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Genital Prolapse | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Orchitis Noninfective | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Ovarian Cyst | 0/1441 (0%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Pelvic Prolapse | 0/1441 (0%) | 0/1445 (0%) | 2/1441 (0.1%) | |||
| Prostatic Calcification | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Prostatitis | 1/1441 (0.1%) | 2/1445 (0.1%) | 1/1441 (0.1%) | |||
| Prostatomegaly | 0/1441 (0%) | 1/1445 (0.1%) | 2/1441 (0.1%) | |||
| Rectocele | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Uterine Polyp | 1/1441 (0.1%) | 0/1445 (0%) | 2/1441 (0.1%) | |||
| Uterine Prolapse | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Uterovaginal Prolapse | 2/1441 (0.1%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Vaginal Prolapse | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Acute Pulmonary Oedema | 6/1441 (0.4%) | 3/1445 (0.2%) | 0/1441 (0%) | |||
| Acute Respiratory Distress Syndrome | 0/1441 (0%) | 3/1445 (0.2%) | 0/1441 (0%) | |||
| Acute Respiratory Failure | 0/1441 (0%) | 2/1445 (0.1%) | 0/1441 (0%) | |||
| Asthma | 3/1441 (0.2%) | 4/1445 (0.3%) | 1/1441 (0.1%) | |||
| Bronchial Hyperreactivity | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Chronic Obstructive Pulmonary Disease | 7/1441 (0.5%) | 7/1445 (0.5%) | 7/1441 (0.5%) | |||
| Cough | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Diaphragmatic Disorder | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Dysphonia | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Dyspnoea | 8/1441 (0.6%) | 11/1445 (0.8%) | 7/1441 (0.5%) | |||
| Dyspnoea Exertional | 3/1441 (0.2%) | 4/1445 (0.3%) | 0/1441 (0%) | |||
| Epistaxis | 3/1441 (0.2%) | 2/1445 (0.1%) | 4/1441 (0.3%) | |||
| Haemoptysis | 1/1441 (0.1%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Hypoxia | 1/1441 (0.1%) | 0/1445 (0%) | 2/1441 (0.1%) | |||
| Idiopathic Pulmonary Fibrosis | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Interstitial Lung Disease | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Laryngeal Oedema | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Lung Consolidation | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Lung Infiltration | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Nasal Polyps | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Organising Pneumonia | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Pleural Effusion | 0/1441 (0%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Pneumonia Aspiration | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Pneumonitis | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Pneumothorax | 1/1441 (0.1%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Productive Cough | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Pulmonary Embolism | 7/1441 (0.5%) | 5/1445 (0.3%) | 9/1441 (0.6%) | |||
| Pulmonary Fibrosis | 1/1441 (0.1%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Pulmonary Hypertension | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Pulmonary Oedema | 3/1441 (0.2%) | 1/1445 (0.1%) | 2/1441 (0.1%) | |||
| Pulmonary Vein Stenosis | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Respiratory Acidosis | 0/1441 (0%) | 2/1445 (0.1%) | 0/1441 (0%) | |||
| Respiratory Arrest | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Respiratory Distress | 0/1441 (0%) | 2/1445 (0.1%) | 0/1441 (0%) | |||
| Respiratory Failure | 6/1441 (0.4%) | 3/1445 (0.2%) | 3/1441 (0.2%) | |||
| Sinus Polyp | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Sleep Apnoea Syndrome | 4/1441 (0.3%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Angioedema | 1/1441 (0.1%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Decubitus Ulcer | 0/1441 (0%) | 2/1445 (0.1%) | 0/1441 (0%) | |||
| Dermatitis Contact | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Diabetic Foot | 4/1441 (0.3%) | 9/1445 (0.6%) | 10/1441 (0.7%) | |||
| Diabetic Neuropathic Ulcer | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Diabetic Ulcer | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Drug Eruption | 0/1441 (0%) | 2/1445 (0.1%) | 0/1441 (0%) | |||
| Eczema | 1/1441 (0.1%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Guttate Psoriasis | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Hyperhidrosis | 0/1441 (0%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Hypersensitivity Vasculitis | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Keloid Scar | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Lichen Planus | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Necrobiosis Lipoidica Diabeticorum | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Neurodermatitis | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Rash | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Skin Disorder | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Skin Lesion | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Skin Ulcer | 2/1441 (0.1%) | 10/1445 (0.7%) | 14/1441 (1%) | |||
| Urticaria | 0/1441 (0%) | 2/1445 (0.1%) | 0/1441 (0%) | |||
| Surgical and medical procedures | ||||||
| Arrhythmia Prophylaxis | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Fracture Treatment | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Gastric Bypass | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Hip Arthroplasty | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Incisional Hernia Repair | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Vascular disorders | ||||||
| Accelerated Hypertension | 2/1441 (0.1%) | 0/1445 (0%) | 2/1441 (0.1%) | |||
| Aortic Aneurysm | 4/1441 (0.3%) | 2/1445 (0.1%) | 0/1441 (0%) | |||
| Aortic Stenosis | 1/1441 (0.1%) | 3/1445 (0.2%) | 3/1441 (0.2%) | |||
| Arterial Disorder | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Arterial Occlusive Disease | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Arterial Thrombosis | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Arteriosclerosis | 1/1441 (0.1%) | 2/1445 (0.1%) | 1/1441 (0.1%) | |||
| Blood Pressure Inadequately Controlled | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Circulatory Collapse | 1/1441 (0.1%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Deep Vein Thrombosis | 3/1441 (0.2%) | 4/1445 (0.3%) | 5/1441 (0.3%) | |||
| Dry Gangrene | 1/1441 (0.1%) | 0/1445 (0%) | 2/1441 (0.1%) | |||
| Extremity Necrosis | 0/1441 (0%) | 1/1445 (0.1%) | 4/1441 (0.3%) | |||
| Haematoma | 1/1441 (0.1%) | 2/1445 (0.1%) | 0/1441 (0%) | |||
| Haemorrhage | 0/1441 (0%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Hypertension | 10/1441 (0.7%) | 3/1445 (0.2%) | 2/1441 (0.1%) | |||
| Hypertensive Crisis | 4/1441 (0.3%) | 5/1445 (0.3%) | 3/1441 (0.2%) | |||
| Hypertensive Emergency | 1/1441 (0.1%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Hypotension | 3/1441 (0.2%) | 5/1445 (0.3%) | 3/1441 (0.2%) | |||
| Iliac Artery Occlusion | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Intermittent Claudication | 3/1441 (0.2%) | 3/1445 (0.2%) | 4/1441 (0.3%) | |||
| Ischaemia | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Leriche Syndrome | 0/1441 (0%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Lymphoedema | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Malignant Hypertension | 1/1441 (0.1%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Neurogenic Shock | 0/1441 (0%) | 2/1445 (0.1%) | 0/1441 (0%) | |||
| Orthostatic Hypotension | 1/1441 (0.1%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Peripheral Arterial Occlusive Disease | 4/1441 (0.3%) | 12/1445 (0.8%) | 11/1441 (0.8%) | |||
| Peripheral Artery Aneurysm | 1/1441 (0.1%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Peripheral Artery Occlusion | 1/1441 (0.1%) | 7/1445 (0.5%) | 1/1441 (0.1%) | |||
| Peripheral Artery Stenosis | 4/1441 (0.3%) | 5/1445 (0.3%) | 7/1441 (0.5%) | |||
| Peripheral Artery Thrombosis | 1/1441 (0.1%) | 1/1445 (0.1%) | 1/1441 (0.1%) | |||
| Peripheral Ischaemia | 9/1441 (0.6%) | 9/1445 (0.6%) | 6/1441 (0.4%) | |||
| Peripheral Vascular Disorder | 7/1441 (0.5%) | 8/1445 (0.6%) | 10/1441 (0.7%) | |||
| Subclavian Artery Stenosis | 1/1441 (0.1%) | 0/1445 (0%) | 0/1441 (0%) | |||
| Thrombophlebitis Superficial | 1/1441 (0.1%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
| Thrombosis | 1/1441 (0.1%) | 1/1445 (0.1%) | 0/1441 (0%) | |||
| Varicose Vein | 3/1441 (0.2%) | 0/1445 (0%) | 1/1441 (0.1%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Placebo | Canagliflozin 100 mg | Canagliflozin 300 mg | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1137/1441 (78.9%) | 1146/1445 (79.3%) | 1167/1441 (81%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia | 55/1441 (3.8%) | 41/1445 (2.8%) | 40/1441 (2.8%) | |||
| Cardiac disorders | ||||||
| Angina Pectoris | 36/1441 (2.5%) | 25/1445 (1.7%) | 30/1441 (2.1%) | |||
| Atrial Fibrillation | 38/1441 (2.6%) | 38/1445 (2.6%) | 29/1441 (2%) | |||
| Ear and labyrinth disorders | ||||||
| Vertigo | 42/1441 (2.9%) | 50/1445 (3.5%) | 54/1441 (3.7%) | |||
| Eye disorders | ||||||
| Cataract | 77/1441 (5.3%) | 91/1445 (6.3%) | 84/1441 (5.8%) | |||
| Diabetic Retinopathy | 46/1441 (3.2%) | 45/1445 (3.1%) | 50/1441 (3.5%) | |||
| Gastrointestinal disorders | ||||||
| Abdominal Pain | 40/1441 (2.8%) | 42/1445 (2.9%) | 47/1441 (3.3%) | |||
| Abdominal Pain Upper | 35/1441 (2.4%) | 33/1445 (2.3%) | 31/1441 (2.2%) | |||
| Constipation | 61/1441 (4.2%) | 73/1445 (5.1%) | 70/1441 (4.9%) | |||
| Diarrhoea | 119/1441 (8.3%) | 105/1445 (7.3%) | 147/1441 (10.2%) | |||
| Dyspepsia | 46/1441 (3.2%) | 43/1445 (3%) | 32/1441 (2.2%) | |||
| Gastritis | 31/1441 (2.2%) | 44/1445 (3%) | 38/1441 (2.6%) | |||
| Gastrooesophageal Reflux Disease | 32/1441 (2.2%) | 41/1445 (2.8%) | 46/1441 (3.2%) | |||
| Nausea | 57/1441 (4%) | 60/1445 (4.2%) | 58/1441 (4%) | |||
| Toothache | 31/1441 (2.2%) | 38/1445 (2.6%) | 32/1441 (2.2%) | |||
| Vomiting | 39/1441 (2.7%) | 42/1445 (2.9%) | 39/1441 (2.7%) | |||
| General disorders | ||||||
| Asthenia | 24/1441 (1.7%) | 30/1445 (2.1%) | 38/1441 (2.6%) | |||
| Chest Pain | 57/1441 (4%) | 63/1445 (4.4%) | 61/1441 (4.2%) | |||
| Fatigue | 57/1441 (4%) | 59/1445 (4.1%) | 59/1441 (4.1%) | |||
| Oedema Peripheral | 86/1441 (6%) | 54/1445 (3.7%) | 62/1441 (4.3%) | |||
| Pyrexia | 47/1441 (3.3%) | 39/1445 (2.7%) | 35/1441 (2.4%) | |||
| Thirst | 1/1441 (0.1%) | 19/1445 (1.3%) | 29/1441 (2%) | |||
| Hepatobiliary disorders | ||||||
| Hepatic Steatosis | 32/1441 (2.2%) | 18/1445 (1.2%) | 20/1441 (1.4%) | |||
| Infections and infestations | ||||||
| Bronchitis | 123/1441 (8.5%) | 109/1445 (7.5%) | 112/1441 (7.8%) | |||
| Cellulitis | 26/1441 (1.8%) | 37/1445 (2.6%) | 37/1441 (2.6%) | |||
| Conjunctivitis | 22/1441 (1.5%) | 34/1445 (2.4%) | 24/1441 (1.7%) | |||
| Cystitis | 23/1441 (1.6%) | 35/1445 (2.4%) | 34/1441 (2.4%) | |||
| Gastroenteritis | 42/1441 (2.9%) | 54/1445 (3.7%) | 43/1441 (3%) | |||
| Genital Infection Fungal | 6/1441 (0.4%) | 19/1445 (1.3%) | 30/1441 (2.1%) | |||
| Influenza | 86/1441 (6%) | 100/1445 (6.9%) | 82/1441 (5.7%) | |||
| Localised Infection | 26/1441 (1.8%) | 18/1445 (1.2%) | 30/1441 (2.1%) | |||
| Lower Respiratory Tract Infection | 33/1441 (2.3%) | 32/1445 (2.2%) | 28/1441 (1.9%) | |||
| Nasopharyngitis | 220/1441 (15.3%) | 225/1445 (15.6%) | 203/1441 (14.1%) | |||
| Pharyngitis | 31/1441 (2.2%) | 43/1445 (3%) | 24/1441 (1.7%) | |||
| Pneumonia | 39/1441 (2.7%) | 23/1445 (1.6%) | 39/1441 (2.7%) | |||
| Sinusitis | 45/1441 (3.1%) | 58/1445 (4%) | 65/1441 (4.5%) | |||
| Upper Respiratory Tract Infection | 163/1441 (11.3%) | 157/1445 (10.9%) | 133/1441 (9.2%) | |||
| Urinary Tract Infection | 128/1441 (8.9%) | 132/1445 (9.1%) | 159/1441 (11%) | |||
| Viral Infection | 26/1441 (1.8%) | 32/1445 (2.2%) | 33/1441 (2.3%) | |||
| Vulvovaginal Mycotic Infection | 10/1441 (0.7%) | 30/1445 (2.1%) | 31/1441 (2.2%) | |||
| Injury, poisoning and procedural complications | ||||||
| Contusion | 34/1441 (2.4%) | 38/1445 (2.6%) | 36/1441 (2.5%) | |||
| Ligament Sprain | 24/1441 (1.7%) | 33/1445 (2.3%) | 19/1441 (1.3%) | |||
| Limb Injury | 33/1441 (2.3%) | 31/1445 (2.1%) | 26/1441 (1.8%) | |||
| Investigations | ||||||
| Blood Creatine Phosphokinase Increased | 31/1441 (2.2%) | 20/1445 (1.4%) | 19/1441 (1.3%) | |||
| Blood Creatinine Increased | 28/1441 (1.9%) | 33/1445 (2.3%) | 35/1441 (2.4%) | |||
| Blood Pressure Increased | 35/1441 (2.4%) | 17/1445 (1.2%) | 19/1441 (1.3%) | |||
| Metabolism and nutrition disorders | ||||||
| Hyperglycaemia | 91/1441 (6.3%) | 55/1445 (3.8%) | 63/1441 (4.4%) | |||
| Hypoglycaemia | 174/1441 (12.1%) | 181/1445 (12.5%) | 210/1441 (14.6%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Arthralgia | 125/1441 (8.7%) | 133/1445 (9.2%) | 129/1441 (9%) | |||
| Back Pain | 137/1441 (9.5%) | 138/1445 (9.6%) | 149/1441 (10.3%) | |||
| Muscle Spasms | 52/1441 (3.6%) | 40/1445 (2.8%) | 52/1441 (3.6%) | |||
| Musculoskeletal Pain | 65/1441 (4.5%) | 69/1445 (4.8%) | 64/1441 (4.4%) | |||
| Myalgia | 43/1441 (3%) | 49/1445 (3.4%) | 36/1441 (2.5%) | |||
| Neck Pain | 22/1441 (1.5%) | 20/1445 (1.4%) | 30/1441 (2.1%) | |||
| Osteoarthritis | 84/1441 (5.8%) | 83/1445 (5.7%) | 83/1441 (5.8%) | |||
| Pain in Extremity | 98/1441 (6.8%) | 105/1445 (7.3%) | 92/1441 (6.4%) | |||
| Nervous system disorders | ||||||
| Diabetic Neuropathy | 40/1441 (2.8%) | 34/1445 (2.4%) | 41/1441 (2.8%) | |||
| Dizziness | 33/1441 (2.3%) | 34/1445 (2.4%) | 61/1441 (4.2%) | |||
| Headache | 108/1441 (7.5%) | 90/1445 (6.2%) | 100/1441 (6.9%) | |||
| Hypoaesthesia | 19/1441 (1.3%) | 34/1445 (2.4%) | 24/1441 (1.7%) | |||
| Neuropathy Peripheral | 26/1441 (1.8%) | 33/1445 (2.3%) | 24/1441 (1.7%) | |||
| Psychiatric disorders | ||||||
| Depression | 33/1441 (2.3%) | 39/1445 (2.7%) | 38/1441 (2.6%) | |||
| Insomnia | 37/1441 (2.6%) | 29/1445 (2%) | 39/1441 (2.7%) | |||
| Renal and urinary disorders | ||||||
| Dysuria | 15/1441 (1%) | 30/1445 (2.1%) | 32/1441 (2.2%) | |||
| Pollakiuria | 19/1441 (1.3%) | 66/1445 (4.6%) | 86/1441 (6%) | |||
| Reproductive system and breast disorders | ||||||
| Balanoposthitis | 25/1441 (1.7%) | 87/1445 (6%) | 100/1441 (6.9%) | |||
| Benign Prostatic Hyperplasia | 29/1441 (2%) | 37/1445 (2.6%) | 36/1441 (2.5%) | |||
| Vulvovaginal Pruritus | 7/1441 (0.5%) | 29/1445 (2%) | 21/1441 (1.5%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Cough | 104/1441 (7.2%) | 103/1445 (7.1%) | 97/1441 (6.7%) | |||
| Dyspnoea | 47/1441 (3.3%) | 39/1445 (2.7%) | 42/1441 (2.9%) | |||
| Oropharyngeal Pain | 33/1441 (2.3%) | 41/1445 (2.8%) | 34/1441 (2.4%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Pruritus | 37/1441 (2.6%) | 19/1445 (1.3%) | 30/1441 (2.1%) | |||
| Rash | 28/1441 (1.9%) | 38/1445 (2.6%) | 45/1441 (3.1%) | |||
| Skin Lesion | 8/1441 (0.6%) | 16/1445 (1.1%) | 30/1441 (2.1%) | |||
| Skin Ulcer | 31/1441 (2.2%) | 45/1445 (3.1%) | 51/1441 (3.5%) | |||
| Vascular disorders | ||||||
| Hypertension | 123/1441 (8.5%) | 77/1445 (5.3%) | 75/1441 (5.2%) | |||
| Hypotension | 15/1441 (1%) | 39/1445 (2.7%) | 54/1441 (3.7%) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Results Point of Contact
| Name/Title | Senior Director Clinical Leader |
|---|---|
| Organization | Janssen- Cilag International NV |
| Phone | 844-434-4210 |
| ClinicalTrialDisclosure@its.jnj.com |
Responsible Party:
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01032629
Other Study ID Numbers:
- CR016627
- 28431754DIA3008
- 2009-012140-16
First Posted:
Dec 15, 2009
Last Update Posted:
Dec 7, 2018
Last Verified:
Nov 1, 2018