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A Study of the Effects of Canagliflozin (JNJ-28431754) on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus (CANVAS-R)

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ClinicalTrials.gov Identifier: NCT01989754
Recruitment Status : Completed
First Posted : November 21, 2013
Results First Posted : December 11, 2018
Last Update Posted : December 11, 2018
Sponsor:
Collaborator:
The George Institute for Global Health, Australia
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Diabetes Mellitus, Type 2
Albuminuria
Interventions Drug: Placebo
Drug: Canagliflozin, 100 mg
Drug: Canagliflozin, 300 mg
Enrollment 5813
Recruitment Details  
Pre-assignment Details A total of 5,813 participants were randomized. However, 1 participant was randomized twice and only the first randomization was included in the Intent-to-treat (ITT) analysis set. Thus 2,905 and 2,907 participants were randomly assigned to the placebo and canagliflozin groups in the ITT analysis set, respectively.
Arm/Group Title Placebo (Placebo) Canagliflozin (Experimental)
Hide Arm/Group Description Participants received one capsule of matching placebo orally once daily for the duration of the study or until early discontinuation from treatment. Participants received canagliflozin (JNJ-28431754) 100 milligram (mg) once daily during the first 13 weeks, then the dose was increased to 300 mg once daily (if the participant required additional glycemic control, provided the 100-mg dose was well tolerated).
Period Title: Overall Study
Started 2905 2907
Treated 2903 2904
Completed 2866 [1] 2872 [1]
Not Completed 39 35
Reason Not Completed
Withdrawal by Subject             10             14
Lost to Follow-up             28             20
Closed Site             1             1
[1]
Participants who died are included in this category.
Arm/Group Title Placebo (Placebo) Canagliflozin (Experimental) Total
Hide Arm/Group Description Participants received one capsule of matching placebo orally once daily for the duration of the study or until early discontinuation from treatment. Participants received canagliflozin (JNJ-28431754) 100 milligram (mg) once daily during the first 13 weeks, then the dose was increased to 300 mg once daily (if the participant required additional glycemic control, provided the 100-mg dose was well tolerated). Total of all reporting groups
Overall Number of Baseline Participants 2905 2907 5812
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2905 participants 2907 participants 5812 participants
64  (8.28) 63.9  (8.42) 64  (8.35)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2905 participants 2907 participants 5812 participants
Female
1111
  38.2%
1053
  36.2%
2164
  37.2%
Male
1794
  61.8%
1854
  63.8%
3648
  62.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2905 participants 2907 participants 5812 participants
Hispanic or Latino
586
  20.2%
604
  20.8%
1190
  20.5%
Not Hispanic or Latino
2303
  79.3%
2290
  78.8%
4593
  79.0%
Unknown or Not Reported
16
   0.6%
13
   0.4%
29
   0.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2905 participants 2907 participants 5812 participants
American Indian or Alaska Native
19
   0.7%
14
   0.5%
33
   0.6%
Asian
245
   8.4%
244
   8.4%
489
   8.4%
Native Hawaiian or Other Pacific Islander
09
   0.3%
08
   0.3%
17
   0.3%
Black or African American
125
   4.3%
106
   3.6%
231
   4.0%
White
2372
  81.7%
2393
  82.3%
4765
  82.0%
More than one race
10
   0.3%
09
   0.3%
19
   0.3%
Unknown or Not Reported
125
   4.3%
133
   4.6%
258
   4.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2905 participants 2907 participants 5812 participants
Asian
245
   8.4%
244
   8.4%
489
   8.4%
Black or African American
125
   4.3%
106
   3.6%
231
   4.0%
Hispanic or Latino
407
  14.0%
437
  15.0%
844
  14.5%
Other
174
   6.0%
172
   5.9%
346
   6.0%
White Non-Hispanic
1954
  67.3%
1948
  67.0%
3902
  67.1%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2905 participants 2907 participants 5812 participants
ARGENTINA
146
   5.0%
159
   5.5%
305
   5.2%
AUSTRALIA
58
   2.0%
51
   1.8%
109
   1.9%
BELGIUM
86
   3.0%
66
   2.3%
152
   2.6%
BRAZIL
277
   9.5%
272
   9.4%
549
   9.4%
CANADA
136
   4.7%
146
   5.0%
282
   4.9%
CHINA
46
   1.6%
46
   1.6%
92
   1.6%
CZECH REPUBLIC
67
   2.3%
72
   2.5%
139
   2.4%
FRANCE
69
   2.4%
55
   1.9%
124
   2.1%
GERMANY
46
   1.6%
55
   1.9%
101
   1.7%
HUNGARY
82
   2.8%
97
   3.3%
179
   3.1%
ITALY
49
   1.7%
49
   1.7%
98
   1.7%
MALAYSIA
50
   1.7%
42
   1.4%
92
   1.6%
MEXICO
118
   4.1%
110
   3.8%
228
   3.9%
NETHERLANDS
117
   4.0%
132
   4.5%
249
   4.3%
NEW ZEALAND
49
   1.7%
56
   1.9%
105
   1.8%
POLAND
186
   6.4%
177
   6.1%
363
   6.2%
RUSSIAN FEDERATION
213
   7.3%
199
   6.8%
412
   7.1%
SOUTH KOREA
73
   2.5%
94
   3.2%
167
   2.9%
SPAIN
247
   8.5%
249
   8.6%
496
   8.5%
SWEDEN
118
   4.1%
103
   3.5%
221
   3.8%
TAIWAN
44
   1.5%
32
   1.1%
76
   1.3%
UKRAINE
213
   7.3%
236
   8.1%
449
   7.7%
UNITED KINGDOM
78
   2.7%
73
   2.5%
151
   2.6%
UNITED STATES
337
  11.6%
336
  11.6%
673
  11.6%
1.Primary Outcome
Title Progression of Albuminuria
Hide Description Progression defined as the development of micro-albuminuria (Urine Albumin Creatinine Ratio [UACR] 30 to 300 milligram per gram [mg/g]) or macroalbuminuria (Albumin/creatinine ratio [ACR] of greater than [>] 300 mg/g) in a participant with baseline normoalbuminuria (ACR less than [<] 30 mg/g) or the development of macro-albuminuria in a participant with baseline microalbuminuria with an ACR increase greater than or equal to (>=) 30 percent from baseline. Participants with macroalbuminuria at baseline (ACR>300 mg/g) were excluded from the analysis. Event rate was estimated based on the time to the first occurrence of the event.
Time Frame Up to 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The intent to treat (ITT) population included all participants who were randomized. Here 'N' signifies number of participants who were evaluable for this endpoint.
Arm/Group Title Placebo Canagliflozin (Experimental)
Hide Arm/Group Description:
Participants received one capsule of matching placebo orally once daily for the duration of the study or until early discontinuation from treatment.
Participants received canagliflozin (JNJ-28431754) 100 milligram (mg) once daily during the first 13 weeks, then the dose was increased to 300 mg once daily (if the participant required additional glycemic control, provided the 100-mg dose was well tolerated).
Overall Number of Participants Analyzed 2905 2907
Measure Type: Number
Unit of Measure: Events per 1000 patient-year
153.01 99.80
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Canagliflozin (Experimental)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Cox proportional hazard method
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.64
Confidence Interval (2-Sided) 95%
0.57 to 0.73
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Composite of Cardiovascular (CV) Death Events or Hospitalization for Heart Failure
Hide Description Analyses were using adjudicated events, that is (i.e.) CV death events or hospitalization due to heart failure, and adjudication of these outcomes by the Endpoint Adjudication Committee (EAC) were done in a blinded fashion. Event rate was estimated based on the time to the first occurrence of the event.
Time Frame Approximately 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized.
Arm/Group Title Placebo Canagliflozin (Experimental)
Hide Arm/Group Description:
Participants received one capsule of matching placebo orally once daily for the duration of the study or until early discontinuation from treatment.
Participants received canagliflozin (JNJ-28431754) 100 milligram (mg) once daily during the first 13 weeks, then the dose was increased to 300 mg once daily (if the participant required additional glycemic control, provided the 100-mg dose was well tolerated).
Overall Number of Participants Analyzed 2905 2907
Measure Type: Number
Unit of Measure: Events per 1000 patient-years
21.91 15.85
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Canagliflozin (Experimental)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.0148
Comments [Not Specified]
Method Stratified Cox proportional hazard
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.72
Confidence Interval (2-Sided) 95%
0.55 to 0.94
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Cardiovascular (CV) Death
Hide Description Analyses were using adjudicated events, i.e. CV death events, and adjudication of these outcomes by the Endpoint Adjudication Committee (EAC) were done in a blinded fashion. Event rate was estimated based on the time to the first occurrence of the event.
Time Frame Approximately 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized.
Arm/Group Title Placebo Canagliflozin (Experimental)
Hide Arm/Group Description:
Participants received one capsule of matching placebo orally once daily for the duration of the study or until early discontinuation from treatment.
Participants received canagliflozin (JNJ-28431754) 100 milligram (mg) once daily during the first 13 weeks, then the dose was increased to 300 mg once daily (if the participant required additional glycemic control, provided the 100-mg dose was well tolerated).
Overall Number of Participants Analyzed 2905 2907
Measure Type: Number
Unit of Measure: Events per 1000 patient-years
11.60 10.06
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Canagliflozin (Experimental)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.4067
Comments [Not Specified]
Method Stratified Cox proportional hazard
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.86
Confidence Interval (2-Sided) 95%
0.61 to 1.22
Estimation Comments [Not Specified]
Time Frame Approximately 3 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. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
 
Arm/Group Title Placebo (Placebo) Canagliflozin (Experimental)
Hide Arm/Group Description Participants received one capsule of matching placebo orally once daily for the duration of the study or until early discontinuation from treatment. Participants received canagliflozin (JNJ-28431754) 100 milligram (mg) once daily during the first 13 weeks, then the dose was increased to 300 mg once daily (if the participant required additional glycemic control, provided the 100-mg dose was well tolerated).
All-Cause Mortality
Placebo (Placebo) Canagliflozin (Experimental)
Affected / at Risk (%) Affected / at Risk (%)
Total   71/2903 (2.45%)   68/2904 (2.34%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo (Placebo) Canagliflozin (Experimental)
Affected / at Risk (%) Affected / at Risk (%)
Total   775/2903 (26.70%)   714/2904 (24.59%) 
Blood and lymphatic system disorders     
Anaemia * 1  6/2903 (0.21%)  10/2904 (0.34%) 
Febrile Neutropenia * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Iron Deficiency Anaemia * 1  2/2903 (0.07%)  1/2904 (0.03%) 
Polycythaemia * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Thrombocytopenia * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Cardiac disorders     
Acute Coronary Syndrome * 1  11/2903 (0.38%)  4/2904 (0.14%) 
Acute Left Ventricular Failure * 1  1/2903 (0.03%)  1/2904 (0.03%) 
Acute Myocardial Infarction * 1  26/2903 (0.90%)  32/2904 (1.10%) 
Adams-Stokes Syndrome * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Angina Pectoris * 1  33/2903 (1.14%)  22/2904 (0.76%) 
Angina Unstable * 1  42/2903 (1.45%)  42/2904 (1.45%) 
Aortic Valve Disease * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Aortic Valve Incompetence * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Arrhythmia * 1  1/2903 (0.03%)  2/2904 (0.07%) 
Arteriosclerosis Coronary Artery * 1  5/2903 (0.17%)  3/2904 (0.10%) 
Atrial Fibrillation * 1  18/2903 (0.62%)  14/2904 (0.48%) 
Atrial Flutter * 1  7/2903 (0.24%)  5/2904 (0.17%) 
Atrial Tachycardia * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Atrioventricular Block Complete * 1  1/2903 (0.03%)  3/2904 (0.10%) 
Atrioventricular Block Second Degree * 1  1/2903 (0.03%)  2/2904 (0.07%) 
Bradycardia * 1  1/2903 (0.03%)  2/2904 (0.07%) 
Cardiac Arrest * 1  9/2903 (0.31%)  5/2904 (0.17%) 
Cardiac Disorder * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Cardiac Failure * 1  41/2903 (1.41%)  19/2904 (0.65%) 
Cardiac Failure Acute * 1  3/2903 (0.10%)  2/2904 (0.07%) 
Cardiac Failure Chronic * 1  3/2903 (0.10%)  4/2904 (0.14%) 
Cardiac Failure Congestive * 1  18/2903 (0.62%)  11/2904 (0.38%) 
Cardiac Valve Disease * 1  2/2903 (0.07%)  0/2904 (0.00%) 
Cardio-Respiratory Arrest * 1  1/2903 (0.03%)  1/2904 (0.03%) 
Cardiogenic Shock * 1  2/2903 (0.07%)  0/2904 (0.00%) 
Cardiopulmonary Failure * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Conduction Disorder * 1  2/2903 (0.07%)  0/2904 (0.00%) 
Congestive Cardiomyopathy * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Coronary Artery Disease * 1  29/2903 (1.00%)  34/2904 (1.17%) 
Coronary Artery Insufficiency * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Coronary Artery Occlusion * 1  3/2903 (0.10%)  4/2904 (0.14%) 
Coronary Artery Stenosis * 1  8/2903 (0.28%)  5/2904 (0.17%) 
Diabetic Cardiomyopathy * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Ischaemic Cardiomyopathy * 1  4/2903 (0.14%)  1/2904 (0.03%) 
Left Ventricular Dysfunction * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Left Ventricular Failure * 1  1/2903 (0.03%)  1/2904 (0.03%) 
Mitral Valve Stenosis * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Myocardial Fibrosis * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Myocardial Infarction * 1  24/2903 (0.83%)  31/2904 (1.07%) 
Myocardial Ischaemia * 1  9/2903 (0.31%)  7/2904 (0.24%) 
Pericardial Effusion * 1  0/2903 (0.00%)  2/2904 (0.07%) 
Pericarditis * 1  3/2903 (0.10%)  0/2904 (0.00%) 
Prinzmetal Angina * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Right Ventricular Failure * 1  2/2903 (0.07%)  0/2904 (0.00%) 
Sinus Bradycardia * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Sinus Node Dysfunction * 1  4/2903 (0.14%)  0/2904 (0.00%) 
Supraventricular Tachycardia * 1  1/2903 (0.03%)  1/2904 (0.03%) 
Tachycardia * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Tricuspid Valve Incompetence * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Ventricular Arrhythmia * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Ventricular Asystole * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Ventricular Extrasystoles * 1  1/2903 (0.03%)  1/2904 (0.03%) 
Ventricular Fibrillation * 1  0/2903 (0.00%)  2/2904 (0.07%) 
Ventricular Tachycardia * 1  2/2903 (0.07%)  1/2904 (0.03%) 
Ear and labyrinth disorders     
Haematotympanum * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Hypoacusis * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Vertigo * 1  2/2903 (0.07%)  1/2904 (0.03%) 
Endocrine disorders     
Basedow's Disease * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Hyperparathyroidism * 1  2/2903 (0.07%)  0/2904 (0.00%) 
Hyperparathyroidism Primary * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Hyperthyroidism * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Eye disorders     
Amaurosis Fugax * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Cataract * 1  3/2903 (0.10%)  10/2904 (0.34%) 
Diabetic Retinopathy * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Diplopia * 1  1/2903 (0.03%)  2/2904 (0.07%) 
Eye Haemorrhage * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Eye Pain * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Eyelid Ptosis * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Glaucoma * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Macular Fibrosis * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Retinal Artery Occlusion * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Retinal Detachment * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Retinopathy * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Gastrointestinal disorders     
Abdominal Hernia * 1  3/2903 (0.10%)  0/2904 (0.00%) 
Abdominal Pain * 1  5/2903 (0.17%)  2/2904 (0.07%) 
Abdominal Pain Lower * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Abdominal Pain Upper * 1  2/2903 (0.07%)  0/2904 (0.00%) 
Anal Fistula * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Ascites * 1  1/2903 (0.03%)  1/2904 (0.03%) 
Barrett's Oesophagus * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Bowel Movement Irregularity * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Colitis * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Colitis Ischaemic * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Colitis Microscopic * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Colitis Ulcerative * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Colonic Pseudo-Obstruction * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Constipation * 1  1/2903 (0.03%)  1/2904 (0.03%) 
Diarrhoea * 1  4/2903 (0.14%)  1/2904 (0.03%) 
Diverticular Perforation * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Diverticulum * 1  0/2903 (0.00%)  2/2904 (0.07%) 
Diverticulum Intestinal * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Duodenal Ulcer * 1  1/2903 (0.03%)  1/2904 (0.03%) 
Duodenal Ulcer Haemorrhage * 1  2/2903 (0.07%)  0/2904 (0.00%) 
Duodenal Ulcer Perforation * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Enterocolitis * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Food Poisoning * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Gastric Polyps * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Gastroduodenitis * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Gastrointestinal Haemorrhage * 1  3/2903 (0.10%)  3/2904 (0.10%) 
Haematemesis * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Ileus * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Impaired Gastric Emptying * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Inguinal Hernia * 1  4/2903 (0.14%)  2/2904 (0.07%) 
Intestinal Haemorrhage * 1  2/2903 (0.07%)  0/2904 (0.00%) 
Intestinal Ischaemia * 1  3/2903 (0.10%)  0/2904 (0.00%) 
Intestinal Obstruction * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Intestinal Ulcer Perforation * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Large Intestine Perforation * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Lower Gastrointestinal Haemorrhage * 1  1/2903 (0.03%)  1/2904 (0.03%) 
Melaena * 1  0/2903 (0.00%)  2/2904 (0.07%) 
Mesenteric Arterial Occlusion * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Mesenteric Vein Thrombosis * 1  2/2903 (0.07%)  0/2904 (0.00%) 
Oesophageal Obstruction * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Pancreatitis * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Pancreatitis Acute * 1  2/2903 (0.07%)  3/2904 (0.10%) 
Peptic Ulcer * 1  1/2903 (0.03%)  2/2904 (0.07%) 
Pneumoperitoneum * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Rectal Tenesmus * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Salivary Gland Calculus * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Salivary Gland Fistula * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Small Intestinal Obstruction * 1  0/2903 (0.00%)  2/2904 (0.07%) 
Swollen Tongue * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Tooth Disorder * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Umbilical Hernia * 1  1/2903 (0.03%)  6/2904 (0.21%) 
Upper Gastrointestinal Haemorrhage * 1  2/2903 (0.07%)  3/2904 (0.10%) 
Volvulus * 1  1/2903 (0.03%)  0/2904 (0.00%) 
General disorders     
Adverse Drug Reaction * 1  1/2903 (0.03%)  1/2904 (0.03%) 
Cardiac Death * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Chest Discomfort * 1  2/2903 (0.07%)  0/2904 (0.00%) 
Chest Pain * 1  17/2903 (0.59%)  22/2904 (0.76%) 
Complication Associated with Device * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Cyst * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Death * 1  7/2903 (0.24%)  5/2904 (0.17%) 
Drug Intolerance * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Gait Disturbance * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Generalised Oedema * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Impaired Healing * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Malaise * 1  1/2903 (0.03%)  1/2904 (0.03%) 
Non-Cardiac Chest Pain * 1  7/2903 (0.24%)  9/2904 (0.31%) 
Oedema Peripheral * 1  2/2903 (0.07%)  0/2904 (0.00%) 
Peripheral Swelling * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Pyrexia * 1  3/2903 (0.10%)  2/2904 (0.07%) 
Sudden Cardiac Death * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Sudden Death * 1  6/2903 (0.21%)  6/2904 (0.21%) 
Vascular Stent Restenosis * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Vascular Stent Thrombosis * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Hepatobiliary disorders     
Bile Duct Stone * 1  2/2903 (0.07%)  0/2904 (0.00%) 
Biliary Colic * 1  1/2903 (0.03%)  1/2904 (0.03%) 
Cholangitis * 1  0/2903 (0.00%)  2/2904 (0.07%) 
Cholangitis Acute * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Cholecystitis * 1  3/2903 (0.10%)  3/2904 (0.10%) 
Cholecystitis Acute * 1  1/2903 (0.03%)  2/2904 (0.07%) 
Cholelithiasis * 1  7/2903 (0.24%)  5/2904 (0.17%) 
Cholelithiasis Obstructive * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Gallbladder Polyp * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Haemobilia * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Hepatic Cirrhosis * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Hepatic Lesion * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Hydrocholecystis * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Jaundice Cholestatic * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Liver Injury * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Non-Alcoholic Steatohepatitis * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Immune system disorders     
Anaphylactic Reaction * 1  2/2903 (0.07%)  0/2904 (0.00%) 
Drug Hypersensitivity * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Sarcoidosis * 1  1/2903 (0.03%)  1/2904 (0.03%) 
Infections and infestations     
Abscess * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Abscess Limb * 1  2/2903 (0.07%)  1/2904 (0.03%) 
Abscess Neck * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Appendicitis * 1  2/2903 (0.07%)  6/2904 (0.21%) 
Arthritis Bacterial * 1  1/2903 (0.03%)  1/2904 (0.03%) 
Bronchitis * 1  3/2903 (0.10%)  0/2904 (0.00%) 
Campylobacter Gastroenteritis * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Carbuncle * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Cellulitis * 1  11/2903 (0.38%)  9/2904 (0.31%) 
Cellulitis Staphylococcal * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Cellulitis Streptococcal * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Cholecystitis Infective * 1  1/2903 (0.03%)  1/2904 (0.03%) 
Colonic Abscess * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Device Related Infection * 1  1/2903 (0.03%)  2/2904 (0.07%) 
Diabetic Foot Infection * 1  4/2903 (0.14%)  3/2904 (0.10%) 
Diabetic Gangrene * 1  2/2903 (0.07%)  0/2904 (0.00%) 
Diverticulitis * 1  3/2903 (0.10%)  3/2904 (0.10%) 
Ear Infection * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Empyema * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Endocarditis * 1  0/2903 (0.00%)  2/2904 (0.07%) 
Epididymitis * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Erysipelas * 1  5/2903 (0.17%)  0/2904 (0.00%) 
Escherichia Infection * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Escherichia Sepsis * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Escherichia Urinary Tract Infection * 1  1/2903 (0.03%)  2/2904 (0.07%) 
Eye Infection * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Gangrene * 1  2/2903 (0.07%)  5/2904 (0.17%) 
Gastroenteritis * 1  9/2903 (0.31%)  8/2904 (0.28%) 
Gastroenteritis Viral * 1  1/2903 (0.03%)  2/2904 (0.07%) 
Genital Infection Fungal * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Hepatitis B * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Herpes Zoster * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Hiv Infection * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Infected Dermal Cyst * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Infected Skin Ulcer * 1  1/2903 (0.03%)  3/2904 (0.10%) 
Infection * 1  1/2903 (0.03%)  1/2904 (0.03%) 
Infective Exacerbation of Chronic Obstructive Airways Disease * 1  2/2903 (0.07%)  1/2904 (0.03%) 
Influenza * 1  1/2903 (0.03%)  5/2904 (0.17%) 
Intervertebral Discitis * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Laryngitis * 1  0/2903 (0.00%)  2/2904 (0.07%) 
Localised Infection * 1  6/2903 (0.21%)  5/2904 (0.17%) 
Lower Respiratory Tract Infection * 1  6/2903 (0.21%)  1/2904 (0.03%) 
Lung Abscess * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Mastoiditis * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Orchitis * 1  2/2903 (0.07%)  0/2904 (0.00%) 
Osteomyelitis * 1  5/2903 (0.17%)  6/2904 (0.21%) 
Osteomyelitis Chronic * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Otitis Media Acute * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Parasitic Gastroenteritis * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Paronychia * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Pelvic Abscess * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Penile Abscess * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Perinephric Abscess * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Peritonsillar Abscess * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Pharyngotonsillitis * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Pneumococcal Sepsis * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Pneumonia * 1  31/2903 (1.07%)  26/2904 (0.90%) 
Pneumonia Legionella * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Pneumonia Pneumococcal * 1  2/2903 (0.07%)  0/2904 (0.00%) 
Post Procedural Infection * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Post Procedural Sepsis * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Postoperative Wound Infection * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Pulmonary Sepsis * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Pulmonary Tuberculosis * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Pyelonephritis * 1  2/2903 (0.07%)  5/2904 (0.17%) 
Pyelonephritis Acute * 1  3/2903 (0.10%)  1/2904 (0.03%) 
Respiratory Tract Infection * 1  13/2903 (0.45%)  5/2904 (0.17%) 
Scrotal Abscess * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Scrotal Infection * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Sepsis * 1  9/2903 (0.31%)  4/2904 (0.14%) 
Septic Shock * 1  6/2903 (0.21%)  4/2904 (0.14%) 
Sinusitis * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Soft Tissue Infection * 1  0/2903 (0.00%)  2/2904 (0.07%) 
Staphylococcal Infection * 1  2/2903 (0.07%)  0/2904 (0.00%) 
Staphylococcal Sepsis * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Stenotrophomonas Infection * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Subcutaneous Abscess * 1  2/2903 (0.07%)  0/2904 (0.00%) 
Tooth Abscess * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Tooth Infection * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Tracheobronchitis * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Upper Respiratory Tract Infection * 1  2/2903 (0.07%)  2/2904 (0.07%) 
Urinary Tract Infection * 1  13/2903 (0.45%)  11/2904 (0.38%) 
Urinary Tract Infection Enterococcal * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Urosepsis * 1  1/2903 (0.03%)  1/2904 (0.03%) 
Wound Infection * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Injury, poisoning and procedural complications     
Ankle Fracture * 1  2/2903 (0.07%)  0/2904 (0.00%) 
Arterial Bypass Stenosis * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Carotid Artery Restenosis * 1  0/2903 (0.00%)  2/2904 (0.07%) 
Cataract Operation Complication * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Clavicle Fracture * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Concussion * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Contusion * 1  3/2903 (0.10%)  1/2904 (0.03%) 
Craniocerebral Injury * 1  0/2903 (0.00%)  2/2904 (0.07%) 
Epiphyseal Fracture * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Eye Injury * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Facial Bones Fracture * 1  1/2903 (0.03%)  3/2904 (0.10%) 
Fall * 1  4/2903 (0.14%)  5/2904 (0.17%) 
Femoral Neck Fracture * 1  2/2903 (0.07%)  0/2904 (0.00%) 
Femur Fracture * 1  6/2903 (0.21%)  4/2904 (0.14%) 
Fibula Fracture * 1  1/2903 (0.03%)  2/2904 (0.07%) 
Foot Fracture * 1  1/2903 (0.03%)  1/2904 (0.03%) 
Fractured Coccyx * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Hand Fracture * 1  1/2903 (0.03%)  2/2904 (0.07%) 
Head Injury * 1  2/2903 (0.07%)  0/2904 (0.00%) 
Hip Fracture * 1  5/2903 (0.17%)  3/2904 (0.10%) 
Humerus Fracture * 1  2/2903 (0.07%)  3/2904 (0.10%) 
Jaw Fracture * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Joint Dislocation * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Laceration * 1  0/2903 (0.00%)  2/2904 (0.07%) 
Ligament Sprain * 1  2/2903 (0.07%)  0/2904 (0.00%) 
Limb Crushing Injury * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Limb Injury * 1  2/2903 (0.07%)  5/2904 (0.17%) 
Lumbar Vertebral Fracture * 1  1/2903 (0.03%)  1/2904 (0.03%) 
Meniscus Injury * 1  0/2903 (0.00%)  2/2904 (0.07%) 
Patella Fracture * 1  2/2903 (0.07%)  1/2904 (0.03%) 
Pneumocephalus * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Post Laminectomy Syndrome * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Post Procedural Haematoma * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Post Procedural Haematuria * 1  0/2903 (0.00%)  2/2904 (0.07%) 
Post Procedural Haemorrhage * 1  1/2903 (0.03%)  2/2904 (0.07%) 
Postoperative Hernia * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Postoperative Respiratory Failure * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Procedural Headache * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Procedural Pain * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Pubis Fracture * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Radius Fracture * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Rib Fracture * 1  4/2903 (0.14%)  4/2904 (0.14%) 
Road Traffic Accident * 1  0/2903 (0.00%)  2/2904 (0.07%) 
Spinal Fracture * 1  0/2903 (0.00%)  2/2904 (0.07%) 
Subarachnoid Haemorrhage * 1  2/2903 (0.07%)  0/2904 (0.00%) 
Subdural Haematoma * 1  1/2903 (0.03%)  1/2904 (0.03%) 
Suture Related Complication * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Tendon Injury * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Tendon Rupture * 1  2/2903 (0.07%)  0/2904 (0.00%) 
Thermal Burn * 1  1/2903 (0.03%)  2/2904 (0.07%) 
Thoracic Vertebral Fracture * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Tibia Fracture * 1  1/2903 (0.03%)  4/2904 (0.14%) 
Toxicity to Various Agents * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Traumatic Fracture * 1  0/2903 (0.00%)  2/2904 (0.07%) 
Traumatic Ulcer * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Ulna Fracture * 1  1/2903 (0.03%)  2/2904 (0.07%) 
Upper Limb Fracture * 1  2/2903 (0.07%)  1/2904 (0.03%) 
Vascular Graft Stenosis * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Wound * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Wound Dehiscence * 1  1/2903 (0.03%)  1/2904 (0.03%) 
Wound Necrosis * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Wrist Fracture * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Investigations     
Arteriogram Coronary * 1  2/2903 (0.07%)  0/2904 (0.00%) 
Blood Creatinine Increased * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Blood Glucose Increased * 1  3/2903 (0.10%)  0/2904 (0.00%) 
Ejection Fraction Decreased * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Electrocardiogram QT Prolonged * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Electrocardiogram St-T Change * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Electrocardiogram T Wave Inversion * 1  0/2903 (0.00%)  1/2904 (0.03%) 
International Normalised Ratio Increased * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Liver Function Test Increased * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Platelet Count Decreased * 1  1/2903 (0.03%)  0/2904 (0.00%) 
White Blood Cell Count Decreased * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Metabolism and nutrition disorders     
Acidosis * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Cachexia * 1  1/2903 (0.03%)  1/2904 (0.03%) 
Dehydration * 1  2/2903 (0.07%)  3/2904 (0.10%) 
Diabetes Mellitus * 1  18/2903 (0.62%)  5/2904 (0.17%) 
Diabetes Mellitus Inadequate Control * 1  12/2903 (0.41%)  6/2904 (0.21%) 
Diabetic Complication * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Diabetic Ketoacidosis * 1  2/2903 (0.07%)  5/2904 (0.17%) 
Electrolyte Imbalance * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Fluid Overload * 1  2/2903 (0.07%)  1/2904 (0.03%) 
Gout * 1  1/2903 (0.03%)  1/2904 (0.03%) 
Hyperglycaemia * 1  11/2903 (0.38%)  5/2904 (0.17%) 
Hyperkalaemia * 1  5/2903 (0.17%)  2/2904 (0.07%) 
Hyperosmolar Hyperglycaemic State * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Hypertriglyceridaemia * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Hypoglycaemia * 1  9/2903 (0.31%)  6/2904 (0.21%) 
Hypokalaemia * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Hyponatraemia * 1  4/2903 (0.14%)  3/2904 (0.10%) 
Hypovolaemia * 1  2/2903 (0.07%)  1/2904 (0.03%) 
Lactic Acidosis * 1  0/2903 (0.00%)  2/2904 (0.07%) 
Metabolic Acidosis * 1  1/2903 (0.03%)  1/2904 (0.03%) 
Obesity * 1  3/2903 (0.10%)  2/2904 (0.07%) 
Type 2 Diabetes Mellitus * 1  1/2903 (0.03%)  1/2904 (0.03%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  3/2903 (0.10%)  4/2904 (0.14%) 
Arthritis * 1  2/2903 (0.07%)  2/2904 (0.07%) 
Arthropathy * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Back Pain * 1  11/2903 (0.38%)  2/2904 (0.07%) 
Bursitis * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Cervical Spinal Stenosis * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Costochondritis * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Dactylitis * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Dupuytren's Contracture * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Extremity Contracture * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Foot Deformity * 1  0/2903 (0.00%)  2/2904 (0.07%) 
Intervertebral Disc Compression * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Intervertebral Disc Disorder * 1  1/2903 (0.03%)  1/2904 (0.03%) 
Intervertebral Disc Protrusion * 1  5/2903 (0.17%)  7/2904 (0.24%) 
Knee Deformity * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Lumbar Spinal Stenosis * 1  4/2903 (0.14%)  1/2904 (0.03%) 
Muscular Weakness * 1  2/2903 (0.07%)  2/2904 (0.07%) 
Musculoskeletal Chest Pain * 1  2/2903 (0.07%)  2/2904 (0.07%) 
Musculoskeletal Pain * 1  2/2903 (0.07%)  2/2904 (0.07%) 
Osteitis * 1  1/2903 (0.03%)  2/2904 (0.07%) 
Osteoarthritis * 1  16/2903 (0.55%)  13/2904 (0.45%) 
Osteonecrosis * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Pathological Fracture * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Plantar Fasciitis * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Polymyalgia Rheumatica * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Rhabdomyolysis * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Rotator Cuff Syndrome * 1  1/2903 (0.03%)  4/2904 (0.14%) 
Sacroiliitis * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Spinal Column Stenosis * 1  1/2903 (0.03%)  1/2904 (0.03%) 
Spinal Osteoarthritis * 1  4/2903 (0.14%)  1/2904 (0.03%) 
Spinal Pain * 1  3/2903 (0.10%)  3/2904 (0.10%) 
Spondylolisthesis * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Synovial Cyst * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Tendonitis * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Tenosynovitis * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Tenosynovitis Stenosans * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Trigger Finger * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute Myeloid Leukaemia * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Adenocarcinoma Gastric * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Adenocarcinoma of Colon * 1  3/2903 (0.10%)  1/2904 (0.03%) 
Adenosquamous Cell Lung Cancer * 1  1/2903 (0.03%)  0/2904 (0.00%) 
B-Cell Lymphoma * 1  2/2903 (0.07%)  0/2904 (0.00%) 
Basal Cell Carcinoma * 1  2/2903 (0.07%)  2/2904 (0.07%) 
Benign Lung Neoplasm * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Benign Neoplasm * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Benign Neoplasm of Thyroid Gland * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Bile Duct Cancer * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Bladder Cancer * 1  4/2903 (0.14%)  4/2904 (0.14%) 
Bladder Cancer Recurrent * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Bladder Transitional Cell Carcinoma * 1  2/2903 (0.07%)  1/2904 (0.03%) 
Bowen's Disease * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Breast Adenoma * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Breast Cancer * 1  2/2903 (0.07%)  3/2904 (0.10%) 
Breast Cancer Metastatic * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Breast Cancer Stage Ii * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Breast Cancer Stage Iii * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Cerebral Hygroma * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Cholangiocarcinoma * 1  2/2903 (0.07%)  1/2904 (0.03%) 
Chronic Myeloid Leukaemia * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Colon Adenoma * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Colon Cancer * 1  0/2903 (0.00%)  4/2904 (0.14%) 
Colon Cancer Metastatic * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Colorectal Adenocarcinoma * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Colorectal Cancer * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Diffuse Large B-Cell Lymphoma * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Gastric Cancer * 1  1/2903 (0.03%)  2/2904 (0.07%) 
Glioblastoma * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Hodgkin's Disease * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Invasive Ductal Breast Carcinoma * 1  2/2903 (0.07%)  0/2904 (0.00%) 
Large Cell Lung Cancer * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Laryngeal Cancer * 1  1/2903 (0.03%)  1/2904 (0.03%) 
Lipoma * 1  2/2903 (0.07%)  0/2904 (0.00%) 
Lung Adenocarcinoma * 1  2/2903 (0.07%)  4/2904 (0.14%) 
Lung Adenocarcinoma Metastatic * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Lung Cancer Metastatic * 1  1/2903 (0.03%)  1/2904 (0.03%) 
Lung Neoplasm Malignant * 1  6/2903 (0.21%)  6/2904 (0.21%) 
Lymphoma * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Malignant Melanoma * 1  0/2903 (0.00%)  3/2904 (0.10%) 
Malignant Melanoma in Situ * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Malignant Neoplasm of Unknown Primary Site * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Mediastinum Neoplasm * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Meningioma Benign * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Metastases to Central Nervous System * 1  0/2903 (0.00%)  2/2904 (0.07%) 
Metastases to Liver * 1  1/2903 (0.03%)  1/2904 (0.03%) 
Neuroendocrine Carcinoma Metastatic * 1  1/2903 (0.03%)  1/2904 (0.03%) 
Neuroendocrine Tumour * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Non-Hodgkin's Lymphoma * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Non-Small Cell Lung Cancer * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Oesophageal Squamous Cell Carcinoma * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Ovarian Cancer Metastatic * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Pancreatic Carcinoma * 1  6/2903 (0.21%)  1/2904 (0.03%) 
Papillary Cystadenoma Lymphomatosum * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Papillary Thyroid Cancer * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Plasma Cell Myeloma * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Prostate Cancer * 1  8/2903 (0.28%)  0/2904 (0.00%) 
Prostate Cancer Metastatic * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Rectal Cancer * 1  3/2903 (0.10%)  0/2904 (0.00%) 
Renal Cancer * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Schwannoma * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Serous Cystadenocarcinoma of Pancreas * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Small Cell Lung Cancer Metastatic * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Squamous Cell Carcinoma * 1  1/2903 (0.03%)  1/2904 (0.03%) 
Squamous Cell Carcinoma of Lung * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Squamous Cell Carcinoma of Skin * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Squamous Cell Carcinoma of the Oral Cavity * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Squamous Cell Carcinoma of the Tongue * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Tongue Neoplasm Malignant Stage Unspecified * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Ureteric Cancer * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Uterine Cancer * 1  2/2903 (0.07%)  1/2904 (0.03%) 
Uterine Leiomyoma * 1  1/2903 (0.03%)  1/2904 (0.03%) 
Nervous system disorders     
Basilar Artery Occlusion * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Brain Injury * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Brain Stem Infarction * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Brain Stem Stroke * 1  0/2903 (0.00%)  2/2904 (0.07%) 
Carotid Arteriosclerosis * 1  2/2903 (0.07%)  0/2904 (0.00%) 
Carotid Artery Occlusion * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Carotid Artery Stenosis * 1  7/2903 (0.24%)  9/2904 (0.31%) 
Carpal Tunnel Syndrome * 1  1/2903 (0.03%)  1/2904 (0.03%) 
Cerebellar Infarction * 1  1/2903 (0.03%)  1/2904 (0.03%) 
Cerebral Haematoma * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Cerebral Haemorrhage * 1  1/2903 (0.03%)  3/2904 (0.10%) 
Cerebral Infarction * 1  5/2903 (0.17%)  4/2904 (0.14%) 
Cerebral Ischaemia * 1  1/2903 (0.03%)  1/2904 (0.03%) 
Cerebrovascular Accident * 1  37/2903 (1.27%)  15/2904 (0.52%) 
Cervicobrachial Syndrome * 1  1/2903 (0.03%)  1/2904 (0.03%) 
Cognitive Disorder * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Diabetic Mononeuropathy * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Diabetic Neuropathy * 1  1/2903 (0.03%)  2/2904 (0.07%) 
Dizziness Postural * 1  2/2903 (0.07%)  2/2904 (0.07%) 
Embolic Stroke * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Epilepsy * 1  1/2903 (0.03%)  2/2904 (0.07%) 
Facial Nerve Disorder * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Generalised Tonic-Clonic Seizure * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Haemorrhagic Stroke * 1  4/2903 (0.14%)  2/2904 (0.07%) 
Headache * 1  1/2903 (0.03%)  2/2904 (0.07%) 
Hemiparesis * 1  0/2903 (0.00%)  2/2904 (0.07%) 
Hydrocephalus * 1  1/2903 (0.03%)  2/2904 (0.07%) 
Hypertensive Encephalopathy * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Hypoxic-Ischaemic Encephalopathy * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Intraventricular Haemorrhage * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Ischaemic Cerebral Infarction * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Ischaemic Stroke * 1  12/2903 (0.41%)  20/2904 (0.69%) 
Lacunar Infarction * 1  2/2903 (0.07%)  2/2904 (0.07%) 
Lacunar Stroke * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Lethargy * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Loss of Consciousness * 1  0/2903 (0.00%)  2/2904 (0.07%) 
Lumbar Radiculopathy * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Metabolic Encephalopathy * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Migraine * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Myasthenia Gravis * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Myasthenia Gravis Crisis * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Nerve Compression * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Neuralgia * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Paraesthesia * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Peripheral Nerve Paresis * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Presyncope * 1  1/2903 (0.03%)  3/2904 (0.10%) 
Radiculopathy * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Sciatica * 1  2/2903 (0.07%)  0/2904 (0.00%) 
Seizure * 1  2/2903 (0.07%)  0/2904 (0.00%) 
Sensory Loss * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Spinal Cord Compression * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Syncope * 1  8/2903 (0.28%)  10/2904 (0.34%) 
Thalamic Infarction * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Toxic Encephalopathy * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Transient Ischaemic Attack * 1  10/2903 (0.34%)  8/2904 (0.28%) 
Tremor * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Trigeminal Neuralgia * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Vascular Encephalopathy * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Vascular Headache * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Vertebral Artery Occlusion * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Vertebrobasilar Insufficiency * 1  1/2903 (0.03%)  2/2904 (0.07%) 
Vocal Cord Paralysis * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Product Issues     
Device Breakage * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Device Loosening * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Device Malfunction * 1  2/2903 (0.07%)  0/2904 (0.00%) 
Patient-Device Incompatibility * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Psychiatric disorders     
Bipolar Disorder * 1  2/2903 (0.07%)  0/2904 (0.00%) 
Completed Suicide * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Confusional State * 1  2/2903 (0.07%)  1/2904 (0.03%) 
Delirium * 1  2/2903 (0.07%)  0/2904 (0.00%) 
Depression * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Depression Suicidal * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Emotional Disorder * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Major Depression * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Psychotic Disorder * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Suicidal Ideation * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Suicide Attempt * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Renal and urinary disorders     
Acute Kidney Injury * 1  15/2903 (0.52%)  7/2904 (0.24%) 
Bladder Obstruction * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Chronic Kidney Disease * 1  2/2903 (0.07%)  3/2904 (0.10%) 
Diabetic Nephropathy * 1  1/2903 (0.03%)  1/2904 (0.03%) 
Haematuria * 1  1/2903 (0.03%)  3/2904 (0.10%) 
Hydronephrosis * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Ketonuria * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Nephrolithiasis * 1  2/2903 (0.07%)  8/2904 (0.28%) 
Nephropathy * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Nephropathy Toxic * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Nephrotic Syndrome * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Pelvi-Ureteric Obstruction * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Pollakiuria * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Proteinuria * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Renal Colic * 1  0/2903 (0.00%)  2/2904 (0.07%) 
Renal Failure * 1  2/2903 (0.07%)  2/2904 (0.07%) 
Renal Haematoma * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Renal Impairment * 1  2/2903 (0.07%)  1/2904 (0.03%) 
Renal Injury * 1  3/2903 (0.10%)  0/2904 (0.00%) 
Stress Urinary Incontinence * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Tubulointerstitial Nephritis * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Ureterolithiasis * 1  1/2903 (0.03%)  1/2904 (0.03%) 
Urethral Stenosis * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Urinary Incontinence * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Urinary Retention * 1  2/2903 (0.07%)  1/2904 (0.03%) 
Reproductive system and breast disorders     
Balanoposthitis * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Benign Prostatic Hyperplasia * 1  5/2903 (0.17%)  4/2904 (0.14%) 
Endometrial Hyperplasia * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Endometrial Hypertrophy * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Epididymal Disorder * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Erectile Dysfunction * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Fallopian Tube Cyst * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Metrorrhagia * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Peyronie's Disease * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Prostatitis * 1  3/2903 (0.10%)  1/2904 (0.03%) 
Prostatomegaly * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Uterine Polyp * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Uterine Prolapse * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Respiratory, thoracic and mediastinal disorders     
Acute Pulmonary Oedema * 1  5/2903 (0.17%)  0/2904 (0.00%) 
Acute Respiratory Distress Syndrome * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Acute Respiratory Failure * 1  3/2903 (0.10%)  1/2904 (0.03%) 
Asthma * 1  2/2903 (0.07%)  3/2904 (0.10%) 
Asthmatic Crisis * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Atelectasis * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Bronchitis Chronic * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Bronchospasm * 1  2/2903 (0.07%)  1/2904 (0.03%) 
Chronic Obstructive Pulmonary Disease * 1  11/2903 (0.38%)  2/2904 (0.07%) 
Cough * 1  1/2903 (0.03%)  1/2904 (0.03%) 
Dyspnoea * 1  8/2903 (0.28%)  8/2904 (0.28%) 
Epistaxis * 1  0/2903 (0.00%)  3/2904 (0.10%) 
Haemoptysis * 1  2/2903 (0.07%)  0/2904 (0.00%) 
Haemothorax * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Hypoventilation * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Mediastinal Effusion * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Nasal Obstruction * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Pleural Effusion * 1  5/2903 (0.17%)  2/2904 (0.07%) 
Pneumonia Aspiration * 1  2/2903 (0.07%)  0/2904 (0.00%) 
Pneumothorax * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Pulmonary Embolism * 1  5/2903 (0.17%)  6/2904 (0.21%) 
Pulmonary Fibrosis * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Pulmonary Mass * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Pulmonary Oedema * 1  6/2903 (0.21%)  0/2904 (0.00%) 
Pulmonary Sarcoidosis * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Respiratory Acidosis * 1  1/2903 (0.03%)  1/2904 (0.03%) 
Respiratory Alkalosis * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Respiratory Failure * 1  3/2903 (0.10%)  1/2904 (0.03%) 
Sleep Apnoea Syndrome * 1  1/2903 (0.03%)  1/2904 (0.03%) 
Vocal Cord Leukoplakia * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Skin and subcutaneous tissue disorders     
Angioedema * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Dermatitis Allergic * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Diabetic Foot * 1  9/2903 (0.31%)  10/2904 (0.34%) 
Diabetic Ulcer * 1  1/2903 (0.03%)  1/2904 (0.03%) 
Skin Fissures * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Skin Necrosis * 1  0/2903 (0.00%)  2/2904 (0.07%) 
Skin Ulcer * 1  5/2903 (0.17%)  7/2904 (0.24%) 
Urticaria * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Social circumstances     
Penile Prosthesis User * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Victim of Homicide * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Surgical and medical procedures     
Coronary Arterial Stent Insertion * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Hospitalisation * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Stent Placement * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Vascular disorders     
Aortic Aneurysm * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Aortic Arteriosclerosis * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Aortic Stenosis * 1  4/2903 (0.14%)  5/2904 (0.17%) 
Arterial Thrombosis * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Arteriosclerosis * 1  2/2903 (0.07%)  2/2904 (0.07%) 
Circulatory Collapse * 1  1/2903 (0.03%)  1/2904 (0.03%) 
Deep Vein Thrombosis * 1  2/2903 (0.07%)  1/2904 (0.03%) 
Diabetic Vascular Disorder * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Extremity Necrosis * 1  5/2903 (0.17%)  3/2904 (0.10%) 
Haematoma * 1  1/2903 (0.03%)  1/2904 (0.03%) 
Hypertension * 1  4/2903 (0.14%)  1/2904 (0.03%) 
Hypertensive Crisis * 1  6/2903 (0.21%)  1/2904 (0.03%) 
Hypotension * 1  3/2903 (0.10%)  0/2904 (0.00%) 
Hypovolaemic Shock * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Iliac Artery Occlusion * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Intermittent Claudication * 1  3/2903 (0.10%)  4/2904 (0.14%) 
Orthostatic Hypotension * 1  4/2903 (0.14%)  1/2904 (0.03%) 
Peripheral Arterial Occlusive Disease * 1  9/2903 (0.31%)  9/2904 (0.31%) 
Peripheral Artery Occlusion * 1  1/2903 (0.03%)  4/2904 (0.14%) 
Peripheral Artery Stenosis * 1  2/2903 (0.07%)  8/2904 (0.28%) 
Peripheral Artery Thrombosis * 1  1/2903 (0.03%)  0/2904 (0.00%) 
Peripheral Embolism * 1  1/2903 (0.03%)  1/2904 (0.03%) 
Peripheral Ischaemia * 1  5/2903 (0.17%)  7/2904 (0.24%) 
Peripheral Vascular Disorder * 1  4/2903 (0.14%)  9/2904 (0.31%) 
Peripheral Venous Disease * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Poor Peripheral Circulation * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Post Thrombotic Syndrome * 1  0/2903 (0.00%)  1/2904 (0.03%) 
Vascular Insufficiency * 1  0/2903 (0.00%)  1/2904 (0.03%) 
1
Term from vocabulary, MedDRA Version 19.1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Placebo (Placebo) Canagliflozin (Experimental)
Affected / at Risk (%) Affected / at Risk (%)
Total   25/2903 (0.86%)   94/2904 (3.24%) 
Reproductive system and breast disorders     
Balanoposthitis * 1  25/2903 (0.86%)  94/2904 (3.24%) 
1
Term from vocabulary, MedDRA Version 19.1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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: Director Clinical Development
Organization: Janssen Research & Development, LLC
Phone: 844-434-4210
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01989754     History of Changes
Other Study ID Numbers: CR102647
2013-003050-25 ( EudraCT Number )
28431754DIA4003 ( Other Identifier: Janssen Research & Development, LLC )
First Submitted: October 17, 2013
First Posted: November 21, 2013
Results First Submitted: November 19, 2018
Results First Posted: December 11, 2018
Last Update Posted: December 11, 2018