LEADERĀ®: Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT01179048
Collaborator
(none)
9,341
428
2
63.5
21.8
0.3

Study Details

Study Description

Brief Summary

This trial is conducted in Africa, Asia, Europe, and North and South America. The aim of this trial is to determine the long term effect of liraglutide on cardiovascular events in subjects with type 2 diabetes.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
9341 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Long-term, Multi-centre, International, Randomised Double-blind, Placebo-controlled Trial to Determine Liraglutide Effects on Cardiovascular Events
Actual Study Start Date :
Aug 31, 2010
Actual Primary Completion Date :
Dec 17, 2015
Actual Study Completion Date :
Dec 17, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Liraglutide

Drug: liraglutide
Maximum dose of 1.8 mg liraglutide, injected subcutaneously (under the skin) once daily. Administered in addition to the subject's standard treatment

Placebo Comparator: Placebo

Drug: placebo
Maximum dose of 1.8 mg placebo, injected subcutaneously (under the skin) once daily. Administered in addition to the subject's standard treatment

Outcome Measures

Primary Outcome Measures

  1. Time From Randomisation to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome) [from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)]

    Time from randomisation to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite cardiovascular outcome). The percentage of subjects experiencing a first event of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite cardiovascular outcome) is presented.

Secondary Outcome Measures

  1. Time From Rand. to First Occurrence of an Expanded Composite Cardiovascular Outcome Defined as Either Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke, Revascularisation, Hospitalisation for Unstable Angina or for Heart Failure. [from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)]

    Time from randomisation to first occurrence of an expanded composite cardiovascular outcome defined as either cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation, hospitalisation for unstable angina or for heart failure. The percentage of subjects experiencing first occurrence of an expanded composite cardiovascular outcome defined as either cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation, hospitalisation for unstable angina or for heart failure is presented.

  2. Time From Randomisation to All Cause Death [from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)]

    Time from randomisation to all cause death. The percentage of subjects with a death by any cause (all-cause death) is presented.

  3. Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome [from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)]

    Time from randomisation to each individual component of the expanded composite cardiovascular outcome. The percentage of subjects experiencing each of the individual component of the expanded composite cardiovascular outcome (defined as either cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation, hospitalisation for unstable angina or heart failure) is presented.

  4. Time From Randomisation to First Occurrence of a Composite Microvascular Outcome [from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)]

    Time from randomisation to first occurrence of a composite microvascular outcome, defined as any one of the following: new onset of persistent macroalbuminuria persistent doubling of serum creatinine need for continuous renal replacement therapy death due to renal disease need for retinal photocoagulation or treatment with intravitreal agents vitreous haemorrhage diabetes-related blindness The percentage of subjects experiencing a first occurrence of a composite microvascular outcome is presented.

  5. Time From Randomisation to Each Individual Component of the Composite Microvascular Outcome and to the Retinopathy and Nephropathy Composite Outcomes Separately. [from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)]

    Time from randomisation to each individual component of the composite microvascular outcome and to the retinopathy and nephropathy composite outcomes separately. The percentage of subjects experiencing each individual component of the composite microvascular outcome are presented.

Eligibility Criteria

Criteria

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

Inclusion Criteria: - Type 2 diabetes - Age min. 50 years at screening and concomitant cardiovascular, cerebrovascular or peripheral vascular disease or chronic renal failure or chronic heart failure OR age min. 60 years at screening and other specified risk factors of cardiovascular disease - HbA1c: 7.0% or above - Anti-diabetic drug naive or treated with one or more oral anti-diabetic drugs (OADs) or treated with human NPH insulin or long-acting insulin analogue or premixed insulin, alone or in combination with OAD(s) Exclusion Criteria: - Type 1 diabetes - Use of a glucagon-like peptide-1 (GLP-1) receptor agonist (exenatide, liraglutide or other) or pramlintide or any dipeptidyl peptidase 4 (DPP-4) inhibitor within the 3 months prior to screening (trial start) - Use of insulin other than human NPH insulin or long-acting insulin analogue or premixed insulin within 3 months prior to screening. Short-term use of other insulin during this period in connection with intercurrent illness is allowed, at Investigator's discretion

Contacts and Locations

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373 Novo Nordisk Investigational Site Madrid Spain 28040
374 Novo Nordisk Investigational Site Mora De Ebre Spain 43740
375 Novo Nordisk Investigational Site Mostoles - Madrid - Spain 28935
376 Novo Nordisk Investigational Site Palma de Mallorca Spain 07198
377 Novo Nordisk Investigational Site Pozuelo de Alarcon Spain 28223
378 Novo Nordisk Investigational Site Sevilla Spain 41003
379 Novo Nordisk Investigational Site Sevilla Spain 41014
380 Novo Nordisk Investigational Site Valladolid Spain 47005
381 Novo Nordisk Investigational Site Gƶteborg Sweden 413 45
382 Novo Nordisk Investigational Site Malmƶ Sweden 205 02
383 Novo Nordisk Investigational Site Stockholm Sweden 111 57
384 Novo Nordisk Investigational Site Stockholm Sweden 113 24
385 Novo Nordisk Investigational Site Stockholm Sweden 141 86
386 Novo Nordisk Investigational Site Ɩrebro Sweden 701 85
387 Novo Nordisk Investigational Site Changhua City Taiwan 500
388 Novo Nordisk Investigational Site Kaoshiung Taiwan 807
389 Novo Nordisk Investigational Site Tainan city Taiwan 710
390 Novo Nordisk Investigational Site Taoyuan Taiwan 333
391 Novo Nordisk Investigational Site Ankara Turkey 06100
392 Novo Nordisk Investigational Site Ankara Turkey 06500
393 Novo Nordisk Investigational Site Antalya Turkey 07058
394 Novo Nordisk Investigational Site Bursa Turkey 16059
395 Novo Nordisk Investigational Site Gaziantep Turkey 27070
396 Novo Nordisk Investigational Site Istanbul Turkey 34096
397 Novo Nordisk Investigational Site Istanbul Turkey 34098
398 Novo Nordisk Investigational Site Istanbul Turkey 34360
399 Novo Nordisk Investigational Site Istanbul Turkey 34371
400 Novo Nordisk Investigational Site Istanbul Turkey 34390
401 Novo Nordisk Investigational Site Istanbul Turkey 34722
402 Novo Nordisk Investigational Site Istanbul Turkey 34890
403 Novo Nordisk Investigational Site Istanbul Turkey
404 Novo Nordisk Investigational Site Izmir Turkey 35100
405 Novo Nordisk Investigational Site Izmir Turkey 35340
406 Novo Nordisk Investigational Site Kayseri Turkey 38039
407 Novo Nordisk Investigational Site Dubai United Arab Emirates 4545
408 Novo Nordisk Investigational Site Dubai United Arab Emirates 7272
409 Novo Nordisk Investigational Site Aberdeen United Kingdom AB25 1LD
410 Novo Nordisk Investigational Site Birmingham United Kingdom B9 5SS
411 Novo Nordisk Investigational Site Bristol United Kingdom BS10 5NB
412 Novo Nordisk Investigational Site Coventry United Kingdom CV2 2DX
413 Novo Nordisk Investigational Site Devon United Kingdom EX2 5DW
414 Novo Nordisk Investigational Site Dundee United Kingdom DD1 9SY
415 Novo Nordisk Investigational Site Edinburgh United Kingdom EH16 4SA
416 Novo Nordisk Investigational Site Glasgow United Kingdom G31 2ER
417 Novo Nordisk Investigational Site Guildford United Kingdom GU2 7XX
418 Novo Nordisk Investigational Site Hull United Kingdom HU3 2RW
419 Novo Nordisk Investigational Site Livington United Kingdom EH54 6PP
420 Novo Nordisk Investigational Site London United Kingdom W2 1NY
421 Novo Nordisk Investigational Site Manchester United Kingdom M6 8HD
422 Novo Nordisk Investigational Site Norwich United Kingdom NR4 7TJ
423 Novo Nordisk Investigational Site Nuneaton United Kingdom CV10 7DJ
424 Novo Nordisk Investigational Site Plymouth United Kingdom PL6 8BQ
425 Novo Nordisk Investigational Site St Helens United Kingdom WA9 3DA
426 Novo Nordisk Investigational Site Swansea United Kingdom SA6 6NL
427 Novo Nordisk Investigational Site Torquay United Kingdom TQ2 7AA
428 Novo Nordisk Investigational Site West Midlands United Kingdom B71 4HJ

Sponsors and Collaborators

  • Novo Nordisk A/S

Investigators

  • Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01179048
Other Study ID Numbers:
  • EX2211-3748
  • 2009-012201-19
  • U1111-1113-7090
  • CTR20130003
First Posted:
Aug 10, 2010
Last Update Posted:
Jul 17, 2019
Last Verified:
Jul 1, 2019
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details 410 sites in 32 countries across the 4 regions recruited subjects. Number of sites that recruited subjects is given in parenthesis. Europe (143), North America (135) (US, Canada) , Asia (33) (China, Taiwan, Korea, India) and Rest of the world (99) (Brazil, Mexico, Australia, South Africa, Turkey, Russian Federation, United Arab Emirates).
Pre-assignment Detail All subjects received placebo (0.6 mg/day) during the open labeled run-in period of 2-3 weeks and were instructed on how to administer the trial product. During this period the subjects demonstrated that they could adhere to the injection regimen in the trial.
Arm/Group Title Liraglutide Placebo
Arm/Group Description Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months. Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
Period Title: Overall Study
STARTED 4668 4672
COMPLETED 4529 4513
NOT COMPLETED 139 159

Baseline Characteristics

Arm/Group Title Liraglutide Placebo Total
Arm/Group Description Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months. Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months. Total of all reporting groups
Overall Participants 4668 4672 9340
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
64.2
(7.2)
64.4
(7.2)
64.3
(7.2)
Age, Customized (Number) [Number]
Between 18 and 64 years
2512
53.8%
2499
53.5%
5011
53.7%
Between 65 to 84 years
2139
45.8%
2148
46%
4287
45.9%
85 years and over
17
0.4%
25
0.5%
42
0.4%
Sex: Female, Male (Count of Participants)
Female
1657
35.5%
1680
36%
3337
35.7%
Male
3011
64.5%
2992
64%
6003
64.3%

Outcome Measures

1. Primary Outcome
Title Time From Randomisation to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome)
Description Time from randomisation to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite cardiovascular outcome). The percentage of subjects experiencing a first event of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite cardiovascular outcome) is presented.
Time Frame from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)

Outcome Measure Data

Analysis Population Description
All randomised subjects.
Arm/Group Title Liraglutide Placebo
Arm/Group Description Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months. Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
Measure Participants 4668 4672
Number [percentage of subjects]
13.0
14.9
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide, Placebo
Comments The primary endpoint was evaluated using the Cox regression model to estimate the hazard ratio (HR) (liraglutide/placebo) and the 2-sided 95% confidence interval (CI) including treatment group as factor. Non-inferiority of liraglutide versus placebo was considered confirmed, if the upper limit of the two-sided 95% CI for the hazard ratio was below 1.3 or if the p-value for the one-sided test of H0: HR >=1.3 against Ha: HR <1.3 was less than 2.5% (or equivalent to 5% in two-sided test).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority of liraglutide versus placebo was considered confirmed, if the upper limit of the two-sided 95% CI for the hazard ratio was below 1.3 or if the p-value for the one-sided test of H0: HR >=1.3 against Ha: HR <1.3 was less than 2.5% (or equivalent to 5% in two-sided test). If non-inferiority was established for the primary outcome, a test for superiority was to be performed.
Statistical Test of Hypothesis p-Value <0.001
Comments p-value is reported for one-sided (Ī±-level 0.025) test for non-inferiority (hazard ratio >=1.3).
Method Regression, Cox
Comments
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.868
Confidence Interval (2-Sided) 95%
0.778 to 0.968
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Liraglutide, Placebo
Comments If non-inferiority was established for the primary outcome, a test for superiority was performed. Superiority of liraglutide versus placebo was considered confirmed, if the upper limit of the two-sided 95% CI for the hazard ratio was below 1.0 or equivalent if the p-value for the one-sided test of H0: HR >=1.0 against Ha: HR <1.0 was less than 2.5% (or equivalent to 5% in two-sided test).
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.005
Comments p-value is reported for one-sided (Ī±-level 0.025) test for superiority (hazard ratio>=1.0).
Method Regression, Cox
Comments
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.868
Confidence Interval (2-Sided) 95%
0.778 to 0.968
Parameter Dispersion Type:
Value:
Estimation Comments
2. Secondary Outcome
Title Time From Rand. to First Occurrence of an Expanded Composite Cardiovascular Outcome Defined as Either Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke, Revascularisation, Hospitalisation for Unstable Angina or for Heart Failure.
Description Time from randomisation to first occurrence of an expanded composite cardiovascular outcome defined as either cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation, hospitalisation for unstable angina or for heart failure. The percentage of subjects experiencing first occurrence of an expanded composite cardiovascular outcome defined as either cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation, hospitalisation for unstable angina or for heart failure is presented.
Time Frame from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)

Outcome Measure Data

Analysis Population Description
All randomised subjects.
Arm/Group Title Liraglutide Placebo
Arm/Group Description Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months. Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
Measure Participants 4668 4672
Number [percentage of subjects]
20.3
22.7
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide, Placebo
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.881
Confidence Interval (2-Sided) 95%
0.807 to 0.962
Parameter Dispersion Type:
Value:
Estimation Comments
3. Secondary Outcome
Title Time From Randomisation to All Cause Death
Description Time from randomisation to all cause death. The percentage of subjects with a death by any cause (all-cause death) is presented.
Time Frame from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)

Outcome Measure Data

Analysis Population Description
All randomised subjects
Arm/Group Title Liraglutide Placebo
Arm/Group Description Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months. Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
Measure Participants 4668 4672
Number [percentage of subjects]
8.2
9.6
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide, Placebo
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.847
Confidence Interval (2-Sided) 95%
0.739 to 0.971
Parameter Dispersion Type:
Value:
Estimation Comments
4. Secondary Outcome
Title Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome
Description Time from randomisation to each individual component of the expanded composite cardiovascular outcome. The percentage of subjects experiencing each of the individual component of the expanded composite cardiovascular outcome (defined as either cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation, hospitalisation for unstable angina or heart failure) is presented.
Time Frame from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)

Outcome Measure Data

Analysis Population Description
All the randomised subjects.
Arm/Group Title Liraglutide Placebo
Arm/Group Description Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months. Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
Measure Participants 4668 4672
Cardiovascular death
4.7
6.0
Non-fatal stroke
3.4
3.8
Non-fatal myocardial infarction
6.0
6.8
Unstable angina pectoris (hospitalisation)
2.6
2.7
Coronary revascularisation
8.7
9.4
Heart failure (hospitalisation)
4.7
5.3
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide, Placebo
Comments Analysis for percentage of subjects experiencing cardiovascular death was done by Cox regression model with treatment as fixed factor.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.783
Confidence Interval (2-Sided) 95%
0.656 to 0.934
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Liraglutide, Placebo
Comments Analysis for percentage of subjects experiencing non-fatal stroke was done by Cox regression model with treatment as fixed factor
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.894
Confidence Interval (2-Sided) 95%
0.721 to 1.107
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Liraglutide, Placebo
Comments Analysis for percentage of subjects experiencing non-fatal myocardial infarction was done by Cox regression model with treatment as fixed factor
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.878
Confidence Interval (2-Sided) 95%
0.747 to 1.031
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Liraglutide, Placebo
Comments Analysis for percentage of subjects experiencing hospitalisation for unstable angina pectoris was done by Cox regression model with treatment as fixed factor
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.980
Confidence Interval (2-Sided) 95%
0.763 to 1.258
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Liraglutide, Placebo
Comments Analysis for percentage of subjects experiencing coronary revascularisation was done by Cox regression model with treatment as fixed factor
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.912
Confidence Interval (2-Sided) 95%
0.797 to 1.044
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Liraglutide, Placebo
Comments Analysis for percentage of subjects experiencing hospitalisation for heart failure was done by Cox regression model with treatment as fixed factor
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.872
Confidence Interval (2-Sided) 95%
0.727 to 1.046
Parameter Dispersion Type:
Value:
Estimation Comments
5. Secondary Outcome
Title Time From Randomisation to First Occurrence of a Composite Microvascular Outcome
Description Time from randomisation to first occurrence of a composite microvascular outcome, defined as any one of the following: new onset of persistent macroalbuminuria persistent doubling of serum creatinine need for continuous renal replacement therapy death due to renal disease need for retinal photocoagulation or treatment with intravitreal agents vitreous haemorrhage diabetes-related blindness The percentage of subjects experiencing a first occurrence of a composite microvascular outcome is presented.
Time Frame from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)

Outcome Measure Data

Analysis Population Description
All randomised subjects.
Arm/Group Title Liraglutide Placebo
Arm/Group Description Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months. Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
Measure Participants 4668 4672
Number [Percentage of subjects]
7.6
8.9
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide, Placebo
Comments Analysis for percentage of subjects experiencing a first microvascular event was done by Cox regression model with treatment as fixed factor.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.841
Confidence Interval (2-Sided) 95%
0.730 to 0.969
Parameter Dispersion Type:
Value:
Estimation Comments
6. Secondary Outcome
Title Time From Randomisation to Each Individual Component of the Composite Microvascular Outcome and to the Retinopathy and Nephropathy Composite Outcomes Separately.
Description Time from randomisation to each individual component of the composite microvascular outcome and to the retinopathy and nephropathy composite outcomes separately. The percentage of subjects experiencing each individual component of the composite microvascular outcome are presented.
Time Frame from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)

Outcome Measure Data

Analysis Population Description
All randomised subjects
Arm/Group Title Liraglutide Placebo
Arm/Group Description Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months. Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
Measure Participants 4668 4672
Nephropathy composite
5.7
7.2
New onset of persistent macroalbuminuria
3.4
4.6
Persistent doubling of serum creatinine
1.9
2.1
Need for continuous renal-replacement therapy
1.2
1.4
Death due to renal disease
0.2
0.1
Retinopathy composite
2.3
2.0
Treatment with photocoagulation/intravitreal agent
2.1
1.8
Development of diabetes-related blindness
0.0
0.02
Vitreous haemorrhage
0.7
0.5
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide, Placebo
Comments Analysis for percentage of subjects experiencing a composite nephropathy event was done by Cox regression model with treatment as fixed factor.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.782
Confidence Interval (2-Sided) 95%
0.666 to 0.918
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Liraglutide, Placebo
Comments Analysis for percentage of subjects experiencing a new onset of persistant macroalbuminaria event was done by Cox regression model with treatment as fixed factor.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.738
Confidence Interval (2-Sided) 95%
0.602 to 0.905
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Liraglutide, Placebo
Comments Analysis for percentage of subjects experiencing persistent doubling of serum creatinine was done by Cox regression model with treatment as fixed factor.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.890
Confidence Interval (2-Sided) 95%
0.667 to 1.189
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Liraglutide, Placebo
Comments Analysis for percentage of subjects experiencing a need for continuous renal-replacement therapy was done by Cox regression model with treatment as fixed factor.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.869
Confidence Interval (2-Sided) 95%
0.607 to 1.244
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Liraglutide, Placebo
Comments Analysis for percentage of subjects experiencing death due to renal disease was done by Cox regression model with treatment as fixed factor.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.593
Confidence Interval (2-Sided) 95%
0.521 to 4.869
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Liraglutide, Placebo
Comments Analysis for percentage of subjects experiencing composite retinopathy was done by Cox regression model with treatment as fixed factor.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.149
Confidence Interval (2-Sided) 95%
0.869 to 1.519
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Liraglutide, Placebo
Comments Analysis for percentage of subjects experiencing treatment with photocoagulation or intravitreal agents was done by Cox regression model with treatment as fixed factor.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.159
Confidence Interval (2-Sided) 95%
0.869 to 1.546
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Liraglutide, Placebo
Comments Analysis for percentage of subjects experiencing development of diabetes-related blindness was done by Cox regression model with treatment as fixed factor.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.335
Confidence Interval (2-Sided) 95%
0.004 to 30.847
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Liraglutide, Placebo
Comments Analysis for percentage of subjects experiencing vitreous haemorrhage was done by Cox regression model with treatment as fixed factor.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.454
Confidence Interval (2-Sided) 95%
0.845 to 2.502
Parameter Dispersion Type:
Value:
Estimation Comments

Adverse Events

Time Frame Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; up to month 60+30 days of post-treatment follow-up).
Adverse Event Reporting Description Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
Arm/Group Title Liraglutide Placebo
Arm/Group Description Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months. Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
All Cause Mortality
Liraglutide Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN)
Serious Adverse Events
Liraglutide Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 2320/4668 (49.7%) 2354/4672 (50.4%)
Blood and lymphatic system disorders
Anaemia 31/4668 (0.7%) 32 21/4672 (0.4%) 22
Anaemia macrocytic 1/4668 (0%) 1 0/4672 (0%) 0
Anaemia megaloblastic 2/4668 (0%) 2 1/4672 (0%) 1
Anaemia vitamin B12 deficiency 1/4668 (0%) 1 0/4672 (0%) 0
Coagulopathy 1/4668 (0%) 1 1/4672 (0%) 1
Haemolytic anaemia 1/4668 (0%) 1 1/4672 (0%) 1
Haemorrhagic anaemia 1/4668 (0%) 1 4/4672 (0.1%) 5
Hypochromic anaemia 0/4668 (0%) 0 1/4672 (0%) 1
Immune thrombocytopenic purpura 1/4668 (0%) 1 0/4672 (0%) 0
Iron deficiency anaemia 9/4668 (0.2%) 9 13/4672 (0.3%) 13
Leukocytosis 1/4668 (0%) 1 0/4672 (0%) 0
Leukopenia 1/4668 (0%) 1 0/4672 (0%) 0
Lymphadenopathy 1/4668 (0%) 1 0/4672 (0%) 0
Microcytic anaemia 1/4668 (0%) 1 0/4672 (0%) 0
Neutropenia 0/4668 (0%) 0 1/4672 (0%) 1
Normochromic normocytic anaemia 1/4668 (0%) 1 0/4672 (0%) 0
Pancytopenia 1/4668 (0%) 1 0/4672 (0%) 0
Paratracheal lymphadenopathy 1/4668 (0%) 1 0/4672 (0%) 0
Polycythaemia 1/4668 (0%) 1 0/4672 (0%) 0
Splenic embolism 0/4668 (0%) 0 1/4672 (0%) 1
Splenic infarction 2/4668 (0%) 2 1/4672 (0%) 1
Splenomegaly 2/4668 (0%) 2 0/4672 (0%) 0
Thrombocytopenia 1/4668 (0%) 1 1/4672 (0%) 1
Cardiac disorders
Acute coronary syndrome 37/4668 (0.8%) 41 54/4672 (1.2%) 59
Acute left ventricular failure 2/4668 (0%) 2 7/4672 (0.1%) 7
Acute myocardial infarction 155/4668 (3.3%) 176 187/4672 (4%) 211
Adams-Stokes syndrome 2/4668 (0%) 2 0/4672 (0%) 0
Angina pectoris 93/4668 (2%) 105 93/4672 (2%) 106
Angina unstable 144/4668 (3.1%) 179 151/4672 (3.2%) 180
Aortic valve calcification 1/4668 (0%) 1 0/4672 (0%) 0
Aortic valve incompetence 0/4668 (0%) 0 2/4672 (0%) 2
Aortic valve sclerosis 0/4668 (0%) 0 1/4672 (0%) 1
Aortic valve stenosis 6/4668 (0.1%) 6 10/4672 (0.2%) 10
Arrhythmia 10/4668 (0.2%) 11 5/4672 (0.1%) 5
Arrhythmia supraventricular 1/4668 (0%) 1 0/4672 (0%) 0
Arteriosclerosis coronary artery 7/4668 (0.1%) 7 12/4672 (0.3%) 12
Atrial fibrillation 89/4668 (1.9%) 113 97/4672 (2.1%) 112
Atrial flutter 17/4668 (0.4%) 20 16/4672 (0.3%) 18
Atrial tachycardia 1/4668 (0%) 1 4/4672 (0.1%) 4
Atrioventricular block 1/4668 (0%) 1 4/4672 (0.1%) 4
Atrioventricular block complete 10/4668 (0.2%) 10 9/4672 (0.2%) 9
Atrioventricular block first degree 1/4668 (0%) 1 0/4672 (0%) 0
Atrioventricular block second degree 5/4668 (0.1%) 5 4/4672 (0.1%) 4
Atrioventricular dissociation 1/4668 (0%) 1 1/4672 (0%) 1
Bradyarrhythmia 0/4668 (0%) 0 1/4672 (0%) 1
Bradycardia 11/4668 (0.2%) 11 11/4672 (0.2%) 11
Bundle branch block left 2/4668 (0%) 2 2/4672 (0%) 2
Bundle branch block right 0/4668 (0%) 0 1/4672 (0%) 1
Cardiac aneurysm 1/4668 (0%) 1 1/4672 (0%) 1
Cardiac arrest 20/4668 (0.4%) 20 31/4672 (0.7%) 31
Cardiac discomfort 1/4668 (0%) 1 1/4672 (0%) 1
Cardiac disorder 1/4668 (0%) 2 1/4672 (0%) 1
Cardiac failure 115/4668 (2.5%) 138 137/4672 (2.9%) 201
Cardiac failure acute 9/4668 (0.2%) 11 11/4672 (0.2%) 12
Cardiac failure chronic 28/4668 (0.6%) 28 25/4672 (0.5%) 29
Cardiac failure congestive 121/4668 (2.6%) 180 129/4672 (2.8%) 176
Cardiac valve disease 0/4668 (0%) 0 1/4672 (0%) 1
Cardiac ventricular thrombosis 2/4668 (0%) 2 3/4672 (0.1%) 3
Cardio-respiratory arrest 15/4668 (0.3%) 15 13/4672 (0.3%) 15
Cardiogenic shock 4/4668 (0.1%) 4 11/4672 (0.2%) 11
Cardiomegaly 0/4668 (0%) 0 2/4672 (0%) 2
Cardiomyopathy 2/4668 (0%) 2 3/4672 (0.1%) 4
Cardiopulmonary failure 3/4668 (0.1%) 3 6/4672 (0.1%) 6
Cardiorenal syndrome 0/4668 (0%) 0 2/4672 (0%) 2
Cardiovascular disorder 1/4668 (0%) 1 2/4672 (0%) 2
Cardiovascular insufficiency 2/4668 (0%) 2 0/4672 (0%) 0
Chordae tendinae rupture 0/4668 (0%) 0 1/4672 (0%) 1
Congestive cardiomyopathy 2/4668 (0%) 2 3/4672 (0.1%) 3
Cor pulmonale 0/4668 (0%) 0 1/4672 (0%) 2
Cor pulmonale acute 0/4668 (0%) 0 1/4672 (0%) 1
Cor pulmonale chronic 1/4668 (0%) 1 0/4672 (0%) 0
Coronary artery disease 73/4668 (1.6%) 77 87/4672 (1.9%) 89
Coronary artery insufficiency 2/4668 (0%) 2 2/4672 (0%) 2
Coronary artery occlusion 16/4668 (0.3%) 16 10/4672 (0.2%) 10
Coronary artery stenosis 20/4668 (0.4%) 20 35/4672 (0.7%) 36
Coronary ostial stenosis 1/4668 (0%) 1 0/4672 (0%) 0
Dilatation atrial 0/4668 (0%) 0 1/4672 (0%) 1
Extrasystoles 1/4668 (0%) 1 0/4672 (0%) 0
Hypertensive cardiomyopathy 2/4668 (0%) 2 0/4672 (0%) 0
Hypertensive heart disease 2/4668 (0%) 2 3/4672 (0.1%) 3
Ischaemic cardiomyopathy 3/4668 (0.1%) 3 9/4672 (0.2%) 9
Left ventricular dysfunction 5/4668 (0.1%) 5 10/4672 (0.2%) 10
Left ventricular failure 3/4668 (0.1%) 3 7/4672 (0.1%) 7
Left ventricular hypertrophy 3/4668 (0.1%) 3 3/4672 (0.1%) 3
Microvascular coronary artery disease 0/4668 (0%) 0 1/4672 (0%) 1
Mitral valve calcification 0/4668 (0%) 0 1/4672 (0%) 1
Mitral valve incompetence 3/4668 (0.1%) 3 10/4672 (0.2%) 10
Mitral valve stenosis 1/4668 (0%) 1 1/4672 (0%) 1
Myocardial fibrosis 2/4668 (0%) 2 0/4672 (0%) 0
Myocardial infarction 68/4668 (1.5%) 71 84/4672 (1.8%) 89
Myocardial ischaemia 27/4668 (0.6%) 27 33/4672 (0.7%) 35
Myocarditis 0/4668 (0%) 0 1/4672 (0%) 1
Nodal rhythm 0/4668 (0%) 0 1/4672 (0%) 1
Palpitations 3/4668 (0.1%) 3 4/4672 (0.1%) 4
Pericardial cyst 0/4668 (0%) 0 1/4672 (0%) 1
Pericardial effusion 1/4668 (0%) 1 3/4672 (0.1%) 3
Pericardial haemorrhage 1/4668 (0%) 1 0/4672 (0%) 0
Pericarditis 1/4668 (0%) 1 5/4672 (0.1%) 5
Pericarditis uraemic 1/4668 (0%) 1 1/4672 (0%) 1
Pneumopericardium 1/4668 (0%) 1 0/4672 (0%) 0
Postural orthostatic tachycardia syndrome 1/4668 (0%) 1 0/4672 (0%) 0
Rhythm idioventricular 0/4668 (0%) 0 1/4672 (0%) 1
Right ventricular failure 0/4668 (0%) 0 2/4672 (0%) 2
Silent myocardial infarction 1/4668 (0%) 1 1/4672 (0%) 1
Sinus arrest 2/4668 (0%) 2 0/4672 (0%) 0
Sinus bradycardia 0/4668 (0%) 0 6/4672 (0.1%) 6
Sinus node dysfunction 10/4668 (0.2%) 10 9/4672 (0.2%) 9
Sinus tachycardia 2/4668 (0%) 2 1/4672 (0%) 1
Stress cardiomyopathy 0/4668 (0%) 0 2/4672 (0%) 2
Supraventricular extrasystoles 1/4668 (0%) 1 1/4672 (0%) 1
Supraventricular tachycardia 9/4668 (0.2%) 9 7/4672 (0.1%) 9
Systolic dysfunction 0/4668 (0%) 0 1/4672 (0%) 1
Tachyarrhythmia 1/4668 (0%) 1 0/4672 (0%) 0
Tachycardia 4/4668 (0.1%) 4 3/4672 (0.1%) 3
Tricuspid valve incompetence 0/4668 (0%) 0 4/4672 (0.1%) 4
Ventricular arrhythmia 3/4668 (0.1%) 3 0/4672 (0%) 0
Ventricular dyssynchrony 1/4668 (0%) 1 0/4672 (0%) 0
Ventricular extrasystoles 5/4668 (0.1%) 5 3/4672 (0.1%) 3
Ventricular fibrillation 4/4668 (0.1%) 4 6/4672 (0.1%) 6
Ventricular hypokinesia 1/4668 (0%) 1 0/4672 (0%) 0
Ventricular tachyarrhythmia 0/4668 (0%) 0 1/4672 (0%) 1
Ventricular tachycardia 18/4668 (0.4%) 29 8/4672 (0.2%) 11
Wolff-Parkinson-White syndrome 1/4668 (0%) 1 0/4672 (0%) 0
Congenital, familial and genetic disorders
Arteriovenous malformation 1/4668 (0%) 1 0/4672 (0%) 0
Atrial septal defect 1/4668 (0%) 1 0/4672 (0%) 0
Buried penis syndrome 0/4668 (0%) 0 1/4672 (0%) 1
Coarctation of the aorta 1/4668 (0%) 1 0/4672 (0%) 0
Congenital cystic kidney disease 0/4668 (0%) 0 1/4672 (0%) 1
Dermoid cyst 1/4668 (0%) 1 0/4672 (0%) 0
Hamartoma 1/4668 (0%) 1 0/4672 (0%) 0
Hydrocele 1/4668 (0%) 1 1/4672 (0%) 1
Hypertrophic cardiomyopathy 0/4668 (0%) 0 1/4672 (0%) 1
Intracranial lipoma 0/4668 (0%) 0 1/4672 (0%) 1
Pancreas divisum 1/4668 (0%) 1 0/4672 (0%) 0
Phimosis 0/4668 (0%) 0 1/4672 (0%) 1
Tracheo-oesophageal fistula 1/4668 (0%) 1 0/4672 (0%) 0
Ear and labyrinth disorders
Aural polyp 0/4668 (0%) 0 1/4672 (0%) 1
Deafness bilateral 1/4668 (0%) 1 0/4672 (0%) 0
Deafness unilateral 0/4668 (0%) 0 1/4672 (0%) 1
Eustachian tube dysfunction 1/4668 (0%) 1 0/4672 (0%) 0
Hypoacusis 2/4668 (0%) 2 0/4672 (0%) 0
Sudden hearing loss 1/4668 (0%) 1 0/4672 (0%) 0
Vertigo 6/4668 (0.1%) 6 10/4672 (0.2%) 10
Vertigo positional 3/4668 (0.1%) 3 1/4672 (0%) 1
Vestibular disorder 1/4668 (0%) 1 0/4672 (0%) 0
Endocrine disorders
Autoimmune thyroiditis 1/4668 (0%) 1 0/4672 (0%) 0
Cushing's syndrome 1/4668 (0%) 1 0/4672 (0%) 0
Goitre 8/4668 (0.2%) 8 5/4672 (0.1%) 5
Hypercorticoidism 1/4668 (0%) 1 0/4672 (0%) 0
Hyperparathyroidism primary 1/4668 (0%) 1 1/4672 (0%) 1
Hyperthyroidism 2/4668 (0%) 2 1/4672 (0%) 1
Hypoaldosteronism 0/4668 (0%) 0 1/4672 (0%) 1
Hypothyroidism 6/4668 (0.1%) 6 0/4672 (0%) 0
Thyroid C-cell hyperplasia 1/4668 (0%) 1 0/4672 (0%) 0
Thyroiditis 1/4668 (0%) 1 0/4672 (0%) 0
Thyroiditis subacute 1/4668 (0%) 1 0/4672 (0%) 0
Toxic nodular goitre 1/4668 (0%) 1 1/4672 (0%) 1
Eye disorders
Amaurosis 2/4668 (0%) 2 0/4672 (0%) 0
Angle closure glaucoma 0/4668 (0%) 0 1/4672 (0%) 1
Aphakia 1/4668 (0%) 1 0/4672 (0%) 0
Autoimmune uveitis 1/4668 (0%) 1 0/4672 (0%) 0
Blepharitis 1/4668 (0%) 1 0/4672 (0%) 0
Blindness unilateral 2/4668 (0%) 2 0/4672 (0%) 0
Cataract 24/4668 (0.5%) 29 32/4672 (0.7%) 35
Corneal erosion 0/4668 (0%) 0 1/4672 (0%) 1
Diabetic blindness 1/4668 (0%) 1 1/4672 (0%) 1
Diabetic retinal oedema 1/4668 (0%) 1 0/4672 (0%) 0
Diabetic retinopathy 9/4668 (0.2%) 9 15/4672 (0.3%) 15
Diplopia 1/4668 (0%) 1 0/4672 (0%) 0
Eye haemorrhage 0/4668 (0%) 0 1/4672 (0%) 1
Eyelid ptosis 1/4668 (0%) 1 0/4672 (0%) 0
Glaucoma 1/4668 (0%) 1 3/4672 (0.1%) 3
Iridocyclitis 1/4668 (0%) 1 0/4672 (0%) 0
Iritis 0/4668 (0%) 0 1/4672 (0%) 1
Macular fibrosis 2/4668 (0%) 2 4/4672 (0.1%) 4
Macular oedema 1/4668 (0%) 1 1/4672 (0%) 1
Macular rupture 1/4668 (0%) 1 0/4672 (0%) 0
Open angle glaucoma 1/4668 (0%) 1 1/4672 (0%) 1
Optic ischaemic neuropathy 1/4668 (0%) 1 3/4672 (0.1%) 3
Optic nerve infarction 0/4668 (0%) 0 1/4672 (0%) 1
Papilloedema 1/4668 (0%) 1 0/4672 (0%) 0
Retinal aneurysm 1/4668 (0%) 1 0/4672 (0%) 0
Retinal artery embolism 0/4668 (0%) 0 1/4672 (0%) 1
Retinal artery occlusion 2/4668 (0%) 2 1/4672 (0%) 1
Retinal degeneration 1/4668 (0%) 1 1/4672 (0%) 1
Retinal detachment 2/4668 (0%) 2 0/4672 (0%) 0
Retinal haemorrhage 0/4668 (0%) 0 1/4672 (0%) 1
Retinal infarction 2/4668 (0%) 2 0/4672 (0%) 0
Retinal vascular occlusion 0/4668 (0%) 0 1/4672 (0%) 1
Retinal vein occlusion 3/4668 (0.1%) 4 0/4672 (0%) 0
Retinal vein thrombosis 1/4668 (0%) 1 0/4672 (0%) 0
Retinopathy 2/4668 (0%) 2 4/4672 (0.1%) 5
Retinopathy haemorrhagic 1/4668 (0%) 1 0/4672 (0%) 0
Retinopathy proliferative 0/4668 (0%) 0 1/4672 (0%) 1
Ulcerative keratitis 1/4668 (0%) 1 0/4672 (0%) 0
Vision blurred 1/4668 (0%) 1 3/4672 (0.1%) 3
Visual impairment 1/4668 (0%) 1 0/4672 (0%) 0
Vitreous adhesions 2/4668 (0%) 2 0/4672 (0%) 0
Vitreous haemorrhage 6/4668 (0.1%) 6 5/4672 (0.1%) 5
Gastrointestinal disorders
Abdominal discomfort 2/4668 (0%) 2 0/4672 (0%) 0
Abdominal distension 0/4668 (0%) 0 3/4672 (0.1%) 3
Abdominal hernia 2/4668 (0%) 2 5/4672 (0.1%) 5
Abdominal incarcerated hernia 0/4668 (0%) 0 1/4672 (0%) 1
Abdominal mass 1/4668 (0%) 1 0/4672 (0%) 0
Abdominal pain 20/4668 (0.4%) 20 15/4672 (0.3%) 16
Abdominal pain lower 2/4668 (0%) 2 2/4672 (0%) 2
Abdominal pain upper 5/4668 (0.1%) 6 4/4672 (0.1%) 4
Abdominal strangulated hernia 0/4668 (0%) 0 1/4672 (0%) 1
Acid peptic disease 0/4668 (0%) 0 1/4672 (0%) 1
Acquired oesophageal web 0/4668 (0%) 0 1/4672 (0%) 1
Anal fistula 1/4668 (0%) 1 2/4672 (0%) 2
Anal skin tags 0/4668 (0%) 0 1/4672 (0%) 1
Ascites 2/4668 (0%) 2 1/4672 (0%) 1
Barrett's oesophagus 2/4668 (0%) 2 5/4672 (0.1%) 5
Cardiospasm 0/4668 (0%) 0 1/4672 (0%) 1
Change of bowel habit 0/4668 (0%) 0 1/4672 (0%) 1
Chronic gastritis 0/4668 (0%) 0 4/4672 (0.1%) 4
Colitis 9/4668 (0.2%) 9 4/4672 (0.1%) 4
Colitis ischaemic 1/4668 (0%) 1 1/4672 (0%) 1
Colitis ulcerative 2/4668 (0%) 2 1/4672 (0%) 1
Colonic pseudo-obstruction 1/4668 (0%) 1 0/4672 (0%) 0
Constipation 11/4668 (0.2%) 11 7/4672 (0.1%) 7
Crohn's disease 1/4668 (0%) 1 1/4672 (0%) 1
Diarrhoea 14/4668 (0.3%) 14 11/4672 (0.2%) 11
Diverticular perforation 2/4668 (0%) 2 4/4672 (0.1%) 4
Diverticulitis intestinal haemorrhagic 0/4668 (0%) 0 1/4672 (0%) 1
Diverticulum 2/4668 (0%) 2 7/4672 (0.1%) 7
Diverticulum intestinal 3/4668 (0.1%) 3 1/4672 (0%) 1
Diverticulum intestinal haemorrhagic 2/4668 (0%) 2 1/4672 (0%) 2
Duodenal perforation 0/4668 (0%) 0 1/4672 (0%) 1
Duodenal polyp 0/4668 (0%) 0 1/4672 (0%) 1
Duodenal ulcer 8/4668 (0.2%) 8 6/4672 (0.1%) 6
Duodenal ulcer haemorrhage 3/4668 (0.1%) 3 5/4672 (0.1%) 5
Duodenal ulcer perforation 2/4668 (0%) 2 0/4672 (0%) 0
Duodenitis 4/4668 (0.1%) 4 2/4672 (0%) 2
Dyspepsia 1/4668 (0%) 1 3/4672 (0.1%) 3
Dysphagia 1/4668 (0%) 1 2/4672 (0%) 2
Enteritis 1/4668 (0%) 1 3/4672 (0.1%) 3
Enterocolitis 2/4668 (0%) 2 2/4672 (0%) 2
Enterocutaneous fistula 1/4668 (0%) 1 1/4672 (0%) 1
Enterovesical fistula 1/4668 (0%) 1 1/4672 (0%) 1
Epigastric discomfort 0/4668 (0%) 0 1/4672 (0%) 1
Erosive oesophagitis 2/4668 (0%) 2 1/4672 (0%) 1
Faecal incontinence 1/4668 (0%) 1 0/4672 (0%) 0
Faecalith 1/4668 (0%) 1 0/4672 (0%) 0
Faecaloma 0/4668 (0%) 0 1/4672 (0%) 1
Food poisoning 1/4668 (0%) 1 1/4672 (0%) 1
Gastric antral vascular ectasia 0/4668 (0%) 0 1/4672 (0%) 1
Gastric haemorrhage 0/4668 (0%) 0 1/4672 (0%) 1
Gastric polyps 2/4668 (0%) 2 3/4672 (0.1%) 3
Gastric ulcer 4/4668 (0.1%) 4 6/4672 (0.1%) 6
Gastric ulcer haemorrhage 5/4668 (0.1%) 5 0/4672 (0%) 0
Gastric ulcer perforation 1/4668 (0%) 1 0/4672 (0%) 0
Gastritis 15/4668 (0.3%) 16 13/4672 (0.3%) 14
Gastritis erosive 4/4668 (0.1%) 4 10/4672 (0.2%) 10
Gastritis haemorrhagic 2/4668 (0%) 3 0/4672 (0%) 0
Gastroduodenitis 1/4668 (0%) 3 0/4672 (0%) 0
Gastrointestinal angiodysplasia 0/4668 (0%) 0 2/4672 (0%) 3
Gastrointestinal disorder 1/4668 (0%) 1 1/4672 (0%) 1
Gastrointestinal haemorrhage 14/4668 (0.3%) 17 21/4672 (0.4%) 27
Gastrointestinal hypomotility 1/4668 (0%) 3 0/4672 (0%) 0
Gastrointestinal necrosis 1/4668 (0%) 1 1/4672 (0%) 1
Gastrointestinal polyp haemorrhage 0/4668 (0%) 0 1/4672 (0%) 1
Gastrointestinal ulcer haemorrhage 2/4668 (0%) 2 0/4672 (0%) 0
Gastrooesophageal reflux disease 11/4668 (0.2%) 11 12/4672 (0.3%) 12
Haematemesis 1/4668 (0%) 1 0/4672 (0%) 0
Haematochezia 1/4668 (0%) 1 5/4672 (0.1%) 5
Haemorrhoidal haemorrhage 2/4668 (0%) 2 1/4672 (0%) 1
Haemorrhoids 3/4668 (0.1%) 3 4/4672 (0.1%) 4
Hiatus hernia 0/4668 (0%) 0 6/4672 (0.1%) 6
Ileus 4/4668 (0.1%) 4 7/4672 (0.1%) 7
Ileus paralytic 1/4668 (0%) 1 2/4672 (0%) 2
Impaired gastric emptying 5/4668 (0.1%) 6 1/4672 (0%) 1
Incarcerated hiatus hernia 0/4668 (0%) 0 1/4672 (0%) 1
Incarcerated inguinal hernia 0/4668 (0%) 0 2/4672 (0%) 2
Incarcerated umbilical hernia 0/4668 (0%) 0 1/4672 (0%) 1
Inflammatory bowel disease 0/4668 (0%) 0 1/4672 (0%) 1
Inguinal hernia 12/4668 (0.3%) 15 14/4672 (0.3%) 14
Intestinal infarction 1/4668 (0%) 1 1/4672 (0%) 1
Intestinal ischaemia 3/4668 (0.1%) 3 2/4672 (0%) 2
Intestinal obstruction 2/4668 (0%) 2 7/4672 (0.1%) 9
Intestinal polyp 0/4668 (0%) 0 2/4672 (0%) 2
Irritable bowel syndrome 0/4668 (0%) 0 2/4672 (0%) 3
Large intestinal ulcer 0/4668 (0%) 0 1/4672 (0%) 1
Large intestine perforation 1/4668 (0%) 1 0/4672 (0%) 0
Large intestine polyp 16/4668 (0.3%) 16 13/4672 (0.3%) 18
Lower gastrointestinal haemorrhage 3/4668 (0.1%) 3 1/4672 (0%) 1
Mallory-Weiss syndrome 2/4668 (0%) 2 1/4672 (0%) 1
Mechanical ileus 0/4668 (0%) 0 2/4672 (0%) 2
Melaena 1/4668 (0%) 1 1/4672 (0%) 1
Mesenteric artery embolism 1/4668 (0%) 1 0/4672 (0%) 0
Nausea 8/4668 (0.2%) 9 9/4672 (0.2%) 9
Obstruction gastric 1/4668 (0%) 1 0/4672 (0%) 0
Oedematous pancreatitis 0/4668 (0%) 0 1/4672 (0%) 1
Oesophageal achalasia 0/4668 (0%) 0 1/4672 (0%) 1
Oesophageal varices haemorrhage 2/4668 (0%) 2 0/4672 (0%) 0
Oesophagitis 1/4668 (0%) 1 1/4672 (0%) 1
Oesophagitis ulcerative 1/4668 (0%) 1 0/4672 (0%) 0
Pancreatic cyst 2/4668 (0%) 2 2/4672 (0%) 2
Pancreatic disorder 1/4668 (0%) 1 2/4672 (0%) 2
Pancreatic mass 2/4668 (0%) 2 0/4672 (0%) 0
Pancreatic pseudocyst 1/4668 (0%) 3 0/4672 (0%) 0
Pancreatitis 18/4668 (0.4%) 20 10/4672 (0.2%) 11
Pancreatitis acute 14/4668 (0.3%) 14 19/4672 (0.4%) 22
Pancreatitis chronic 2/4668 (0%) 2 2/4672 (0%) 2
Pancreatitis relapsing 1/4668 (0%) 1 1/4672 (0%) 1
Peptic ulcer 3/4668 (0.1%) 3 4/4672 (0.1%) 4
Peritoneal adhesions 1/4668 (0%) 1 0/4672 (0%) 0
Peritoneal haematoma 0/4668 (0%) 0 1/4672 (0%) 1
Proctitis ulcerative 1/4668 (0%) 1 0/4672 (0%) 0
Reactive gastropathy 0/4668 (0%) 0 1/4672 (0%) 1
Rectal haemorrhage 6/4668 (0.1%) 7 5/4672 (0.1%) 6
Rectal polyp 3/4668 (0.1%) 3 2/4672 (0%) 2
Rectal prolapse 1/4668 (0%) 1 1/4672 (0%) 1
Reflux gastritis 2/4668 (0%) 2 0/4672 (0%) 0
Retroperitoneal haematoma 1/4668 (0%) 1 0/4672 (0%) 0
Retroperitoneal haemorrhage 1/4668 (0%) 1 1/4672 (0%) 1
Retroperitoneal mass 0/4668 (0%) 0 1/4672 (0%) 1
Salivary gland mass 1/4668 (0%) 1 0/4672 (0%) 0
Short-bowel syndrome 0/4668 (0%) 0 1/4672 (0%) 1
Small intestinal obstruction 10/4668 (0.2%) 12 5/4672 (0.1%) 23
Swollen tongue 1/4668 (0%) 1 0/4672 (0%) 0
Tooth socket haemorrhage 0/4668 (0%) 0 1/4672 (0%) 1
Umbilical hernia 6/4668 (0.1%) 6 4/4672 (0.1%) 4
Upper gastrointestinal haemorrhage 6/4668 (0.1%) 6 8/4672 (0.2%) 8
Volvulus 1/4668 (0%) 8 0/4672 (0%) 0
Vomiting 17/4668 (0.4%) 20 11/4672 (0.2%) 11
General disorders
Adhesion 1/4668 (0%) 1 0/4672 (0%) 0
Adverse drug reaction 1/4668 (0%) 1 1/4672 (0%) 1
Asthenia 9/4668 (0.2%) 10 4/4672 (0.1%) 4
Cardiac death 4/4668 (0.1%) 4 6/4672 (0.1%) 6
Catheter site haemorrhage 1/4668 (0%) 1 0/4672 (0%) 0
Chest discomfort 3/4668 (0.1%) 3 6/4672 (0.1%) 6
Chest pain 53/4668 (1.1%) 56 49/4672 (1%) 52
Chills 1/4668 (0%) 1 0/4672 (0%) 0
Cyst 1/4668 (0%) 1 1/4672 (0%) 1
Death 55/4668 (1.2%) 55 47/4672 (1%) 47
Decreased activity 0/4668 (0%) 0 1/4672 (0%) 1
Device battery issue 0/4668 (0%) 0 1/4672 (0%) 1
Device dislocation 2/4668 (0%) 3 4/4672 (0.1%) 5
Device leakage 0/4668 (0%) 0 1/4672 (0%) 1
Device malfunction 2/4668 (0%) 2 5/4672 (0.1%) 5
Device occlusion 2/4668 (0%) 3 3/4672 (0.1%) 3
Drowning 1/4668 (0%) 1 0/4672 (0%) 0
Drug interaction 1/4668 (0%) 1 0/4672 (0%) 0
Drug withdrawal syndrome 0/4668 (0%) 0 1/4672 (0%) 1
Fatigue 2/4668 (0%) 2 1/4672 (0%) 1
Gait disturbance 0/4668 (0%) 0 2/4672 (0%) 2
General physical health deterioration 1/4668 (0%) 1 3/4672 (0.1%) 3
Generalised oedema 2/4668 (0%) 2 2/4672 (0%) 2
Granuloma 1/4668 (0%) 1 1/4672 (0%) 1
Hernia 2/4668 (0%) 2 0/4672 (0%) 0
Hypothermia 0/4668 (0%) 0 1/4672 (0%) 1
Ill-defined disorder 0/4668 (0%) 0 1/4672 (0%) 1
Impaired healing 4/4668 (0.1%) 4 2/4672 (0%) 2
Incarcerated hernia 2/4668 (0%) 2 1/4672 (0%) 1
Inflammation 0/4668 (0%) 0 1/4672 (0%) 1
Local swelling 1/4668 (0%) 1 0/4672 (0%) 0
Malaise 0/4668 (0%) 0 3/4672 (0.1%) 3
Mass 1/4668 (0%) 1 0/4672 (0%) 0
Medical device complication 2/4668 (0%) 2 0/4672 (0%) 0
Metaplasia 0/4668 (0%) 0 1/4672 (0%) 1
Mucosal inflammation 1/4668 (0%) 1 0/4672 (0%) 0
Multi-organ failure 7/4668 (0.1%) 7 9/4672 (0.2%) 9
Necrosis 0/4668 (0%) 0 1/4672 (0%) 1
Non-cardiac chest pain 45/4668 (1%) 52 63/4672 (1.3%) 73
Oedema 2/4668 (0%) 2 0/4672 (0%) 0
Oedema peripheral 6/4668 (0.1%) 6 9/4672 (0.2%) 10
Pain 2/4668 (0%) 2 3/4672 (0.1%) 3
Peripheral swelling 0/4668 (0%) 0 3/4672 (0.1%) 3
Polyp 0/4668 (0%) 0 1/4672 (0%) 1
Pyrexia 5/4668 (0.1%) 6 6/4672 (0.1%) 6
Stent-graft endoleak 0/4668 (0%) 0 1/4672 (0%) 1
Sudden cardiac death 4/4668 (0.1%) 4 6/4672 (0.1%) 6
Sudden death 11/4668 (0.2%) 11 17/4672 (0.4%) 17
Systemic inflammatory response syndrome 2/4668 (0%) 2 2/4672 (0%) 2
Thrombosis in device 1/4668 (0%) 2 1/4672 (0%) 1
Hepatobiliary disorders
Autoimmune hepatitis 0/4668 (0%) 0 1/4672 (0%) 1
Bile duct stenosis 0/4668 (0%) 0 1/4672 (0%) 5
Bile duct stone 3/4668 (0.1%) 3 1/4672 (0%) 2
Biliary cirrhosis 0/4668 (0%) 0 1/4672 (0%) 1
Biliary colic 5/4668 (0.1%) 5 2/4672 (0%) 3
Biliary fistula 1/4668 (0%) 1 0/4672 (0%) 0
Cholangitis 2/4668 (0%) 3 4/4672 (0.1%) 4
Cholangitis acute 4/4668 (0.1%) 4 0/4672 (0%) 0
Cholecystitis 11/4668 (0.2%) 11 12/4672 (0.3%) 12
Cholecystitis acute 35/4668 (0.7%) 35 18/4672 (0.4%) 19
Cholecystitis chronic 8/4668 (0.2%) 8 5/4672 (0.1%) 5
Cholelithiasis 44/4668 (0.9%) 45 30/4672 (0.6%) 30
Cholestasis 1/4668 (0%) 1 0/4672 (0%) 0
Chronic hepatic failure 0/4668 (0%) 0 2/4672 (0%) 2
Chronic hepatitis 0/4668 (0%) 0 1/4672 (0%) 1
Cirrhosis alcoholic 1/4668 (0%) 1 0/4672 (0%) 0
Cryptogenic cirrhosis 1/4668 (0%) 1 0/4672 (0%) 0
Drug-induced liver injury 0/4668 (0%) 0 1/4672 (0%) 1
Gallbladder disorder 1/4668 (0%) 1 1/4672 (0%) 2
Gallbladder perforation 1/4668 (0%) 1 0/4672 (0%) 0
Gallbladder polyp 2/4668 (0%) 2 1/4672 (0%) 1
Hepatic cirrhosis 4/4668 (0.1%) 4 6/4672 (0.1%) 6
Hepatic cyst 1/4668 (0%) 1 1/4672 (0%) 1
Hepatic failure 2/4668 (0%) 2 0/4672 (0%) 0
Hepatic lesion 0/4668 (0%) 0 1/4672 (0%) 1
Hepatic steatosis 3/4668 (0.1%) 3 0/4672 (0%) 0
Hepatitis acute 1/4668 (0%) 1 0/4672 (0%) 0
Hepatomegaly 1/4668 (0%) 1 0/4672 (0%) 0
Hepatorenal syndrome 1/4668 (0%) 1 0/4672 (0%) 0
Ischaemic hepatitis 0/4668 (0%) 0 1/4672 (0%) 1
Jaundice 1/4668 (0%) 1 0/4672 (0%) 0
Jaundice cholestatic 1/4668 (0%) 1 2/4672 (0%) 2
Liver disorder 1/4668 (0%) 1 1/4672 (0%) 1
Portal hypertension 1/4668 (0%) 1 1/4672 (0%) 1
Portal vein thrombosis 2/4668 (0%) 2 1/4672 (0%) 1
Immune system disorders
Amyloidosis 0/4668 (0%) 0 1/4672 (0%) 1
Anaphylactic reaction 2/4668 (0%) 2 1/4672 (0%) 1
Contrast media allergy 3/4668 (0.1%) 3 0/4672 (0%) 0
Drug hypersensitivity 4/4668 (0.1%) 4 1/4672 (0%) 1
Hypersensitivity 1/4668 (0%) 1 2/4672 (0%) 2
Sarcoidosis 2/4668 (0%) 2 0/4672 (0%) 0
Infections and infestations
Abdominal abscess 2/4668 (0%) 2 0/4672 (0%) 0
Abdominal wall abscess 1/4668 (0%) 2 4/4672 (0.1%) 5
Abscess 0/4668 (0%) 0 1/4672 (0%) 1
Abscess limb 5/4668 (0.1%) 5 6/4672 (0.1%) 6
Abscess neck 1/4668 (0%) 2 2/4672 (0%) 2
Abscess of salivary gland 1/4668 (0%) 1 0/4672 (0%) 0
Acute hepatitis B 1/4668 (0%) 1 0/4672 (0%) 0
Acute sinusitis 1/4668 (0%) 1 0/4672 (0%) 0
Anal abscess 1/4668 (0%) 1 1/4672 (0%) 1
Appendicitis 8/4668 (0.2%) 8 11/4672 (0.2%) 11
Appendicitis perforated 0/4668 (0%) 0 1/4672 (0%) 1
Arteriosclerotic gangrene 0/4668 (0%) 0 1/4672 (0%) 1
Arthritis bacterial 2/4668 (0%) 2 3/4672 (0.1%) 4
Arthritis infective 1/4668 (0%) 1 0/4672 (0%) 0
Atypical pneumonia 1/4668 (0%) 1 0/4672 (0%) 0
Bacteraemia 5/4668 (0.1%) 5 6/4672 (0.1%) 6
Bacterial food poisoning 0/4668 (0%) 0 1/4672 (0%) 1
Bacterial infection 0/4668 (0%) 0 1/4672 (0%) 1
Bacterial sepsis 1/4668 (0%) 1 2/4672 (0%) 2
Biliary sepsis 0/4668 (0%) 0 1/4672 (0%) 1
Biliary tract infection 0/4668 (0%) 0 1/4672 (0%) 1
Breast abscess 0/4668 (0%) 0 2/4672 (0%) 3
Bronchiolitis 0/4668 (0%) 0 1/4672 (0%) 1
Bronchitis 15/4668 (0.3%) 15 24/4672 (0.5%) 25
Bronchopneumonia 11/4668 (0.2%) 13 19/4672 (0.4%) 21
Campylobacter gastroenteritis 1/4668 (0%) 1 1/4672 (0%) 1
Carbuncle 2/4668 (0%) 2 0/4672 (0%) 0
Cardiac valve abscess 1/4668 (0%) 1 0/4672 (0%) 0
Cellulitis 37/4668 (0.8%) 50 54/4672 (1.2%) 61
Cellulitis gangrenous 0/4668 (0%) 0 1/4672 (0%) 1
Cellulitis of male external genital organ 1/4668 (0%) 1 0/4672 (0%) 0
Cervicitis 1/4668 (0%) 1 0/4672 (0%) 0
Cholecystitis infective 3/4668 (0.1%) 3 1/4672 (0%) 1
Cholera 0/4668 (0%) 0 1/4672 (0%) 1
Citrobacter sepsis 0/4668 (0%) 0 1/4672 (0%) 1
Clostridium colitis 1/4668 (0%) 1 0/4672 (0%) 0
Clostridium difficile colitis 6/4668 (0.1%) 6 3/4672 (0.1%) 3
Clostridium difficile infection 1/4668 (0%) 1 1/4672 (0%) 1
Cystitis 7/4668 (0.1%) 7 1/4672 (0%) 1
Dacryocystitis 0/4668 (0%) 0 1/4672 (0%) 1
Dengue fever 0/4668 (0%) 0 1/4672 (0%) 1
Device related infection 5/4668 (0.1%) 5 3/4672 (0.1%) 5
Device related sepsis 1/4668 (0%) 1 1/4672 (0%) 1
Diabetic foot infection 11/4668 (0.2%) 12 9/4672 (0.2%) 11
Diabetic gangrene 1/4668 (0%) 1 2/4672 (0%) 2
Diarrhoea infectious 2/4668 (0%) 2 0/4672 (0%) 0
Diverticulitis 7/4668 (0.1%) 8 13/4672 (0.3%) 13
Dysentery 1/4668 (0%) 1 0/4672 (0%) 0
Ear infection 1/4668 (0%) 1 1/4672 (0%) 1
Endocarditis 3/4668 (0.1%) 3 4/4672 (0.1%) 4
Endocarditis enterococcal 0/4668 (0%) 0 1/4672 (0%) 1
Endocarditis staphylococcal 0/4668 (0%) 0 2/4672 (0%) 2
Endophthalmitis 1/4668 (0%) 1 0/4672 (0%) 0
Enterobacter pneumonia 1/4668 (0%) 1 0/4672 (0%) 0
Enterococcal infection 1/4668 (0%) 1 0/4672 (0%) 0
Epididymitis 1/4668 (0%) 1 1/4672 (0%) 1
Epididymitis ureaplasmal 0/4668 (0%) 0 1/4672 (0%) 1
Erysipelas 10/4668 (0.2%) 11 14/4672 (0.3%) 16
Escherichia bacteraemia 1/4668 (0%) 1 0/4672 (0%) 0
Escherichia pyelonephritis 1/4668 (0%) 1 1/4672 (0%) 1
Escherichia urinary tract infection 1/4668 (0%) 1 0/4672 (0%) 0
Extradural abscess 2/4668 (0%) 2 1/4672 (0%) 1
Eye infection 1/4668 (0%) 1 0/4672 (0%) 0
Gallbladder abscess 0/4668 (0%) 0 1/4672 (0%) 1
Gallbladder empyema 0/4668 (0%) 0 1/4672 (0%) 1
Gangrene 10/4668 (0.2%) 13 12/4672 (0.3%) 14
Gas gangrene 0/4668 (0%) 0 1/4672 (0%) 1
Gastritis bacterial 0/4668 (0%) 0 1/4672 (0%) 1
Gastroenteritis 33/4668 (0.7%) 34 31/4672 (0.7%) 31
Gastroenteritis bacterial 0/4668 (0%) 0 1/4672 (0%) 1
Gastroenteritis norovirus 1/4668 (0%) 1 0/4672 (0%) 0
Gastroenteritis salmonella 1/4668 (0%) 1 0/4672 (0%) 0
Gastroenteritis viral 9/4668 (0.2%) 9 4/4672 (0.1%) 4
Gastrointestinal viral infection 0/4668 (0%) 0 1/4672 (0%) 1
Gingivitis 0/4668 (0%) 0 1/4672 (0%) 1
Groin abscess 0/4668 (0%) 0 1/4672 (0%) 1
Haematoma infection 1/4668 (0%) 2 0/4672 (0%) 0
Helicobacter gastritis 3/4668 (0.1%) 3 1/4672 (0%) 1
Helicobacter infection 1/4668 (0%) 1 0/4672 (0%) 0
Herpes virus infection 0/4668 (0%) 0 1/4672 (0%) 1
Herpes zoster 1/4668 (0%) 1 2/4672 (0%) 2
Human ehrlichiosis 1/4668 (0%) 1 0/4672 (0%) 0
Ileal gangrene 0/4668 (0%) 0 1/4672 (0%) 1
Incision site infection 1/4668 (0%) 1 1/4672 (0%) 1
Infected bites 1/4668 (0%) 1 2/4672 (0%) 2
Infected dermal cyst 1/4668 (0%) 1 1/4672 (0%) 1
Infected skin ulcer 0/4668 (0%) 0 4/4672 (0.1%) 5
Infection 2/4668 (0%) 2 7/4672 (0.1%) 7
Infectious colitis 1/4668 (0%) 1 1/4672 (0%) 1
Infectious pleural effusion 1/4668 (0%) 1 0/4672 (0%) 0
Infective exacerbation of bronchiectasis 0/4668 (0%) 0 1/4672 (0%) 1
Infective exacerbation of chronic obstructive airways disease 2/4668 (0%) 4 1/4672 (0%) 1
Influenza 3/4668 (0.1%) 3 8/4672 (0.2%) 8
Intervertebral discitis 2/4668 (0%) 2 0/4672 (0%) 0
Kidney infection 2/4668 (0%) 2 0/4672 (0%) 0
Klebsiella bacteraemia 0/4668 (0%) 0 1/4672 (0%) 1
Klebsiella sepsis 1/4668 (0%) 1 0/4672 (0%) 0
Laryngitis 1/4668 (0%) 1 1/4672 (0%) 1
Legionella infection 0/4668 (0%) 0 1/4672 (0%) 1
Liver abscess 2/4668 (0%) 2 2/4672 (0%) 2
Lobar pneumonia 15/4668 (0.3%) 16 15/4672 (0.3%) 15
Localised infection 7/4668 (0.1%) 9 8/4672 (0.2%) 8
Lower respiratory tract infection 15/4668 (0.3%) 16 15/4672 (0.3%) 15
Lung infection 2/4668 (0%) 2 5/4672 (0.1%) 5
Mastitis 0/4668 (0%) 0 1/4672 (0%) 1
Mastoiditis 1/4668 (0%) 1 1/4672 (0%) 1
Mediastinitis 0/4668 (0%) 0 1/4672 (0%) 1
Meningitis 1/4668 (0%) 1 2/4672 (0%) 2
Meningitis pneumococcal 1/4668 (0%) 1 0/4672 (0%) 0
Metapneumovirus infection 0/4668 (0%) 0 1/4672 (0%) 1
Nasopharyngitis 1/4668 (0%) 2 0/4672 (0%) 0
Necrotising fasciitis 4/4668 (0.1%) 4 0/4672 (0%) 0
Neutropenic sepsis 1/4668 (0%) 2 0/4672 (0%) 0
Oesophageal candidiasis 1/4668 (0%) 1 0/4672 (0%) 0
Oral candidiasis 1/4668 (0%) 1 1/4672 (0%) 1
Orchitis 2/4668 (0%) 2 2/4672 (0%) 2
Osteomyelitis 21/4668 (0.4%) 27 23/4672 (0.5%) 30
Osteomyelitis acute 1/4668 (0%) 1 0/4672 (0%) 0
Osteomyelitis chronic 0/4668 (0%) 0 2/4672 (0%) 3
Otitis externa 1/4668 (0%) 1 1/4672 (0%) 1
Otitis media 2/4668 (0%) 2 0/4672 (0%) 0
Otitis media chronic 1/4668 (0%) 1 0/4672 (0%) 0
Pancreas infection 0/4668 (0%) 0 1/4672 (0%) 1
Parainfluenzae virus infection 1/4668 (0%) 1 0/4672 (0%) 0
Parotitis 0/4668 (0%) 0 1/4672 (0%) 1
Penile infection 0/4668 (0%) 0 1/4672 (0%) 1
Perichondritis 1/4668 (0%) 1 0/4672 (0%) 0
Peritonitis 5/4668 (0.1%) 6 6/4672 (0.1%) 9
Peritonitis bacterial 3/4668 (0.1%) 3 1/4672 (0%) 1
Peritonsillar abscess 0/4668 (0%) 0 1/4672 (0%) 1
Pharyngitis 1/4668 (0%) 1 1/4672 (0%) 1
Pilonidal cyst 1/4668 (0%) 1 0/4672 (0%) 0
Plasmodium falciparum infection 1/4668 (0%) 1 0/4672 (0%) 0
Pneumococcal sepsis 1/4668 (0%) 1 2/4672 (0%) 2
Pneumonia 133/4668 (2.8%) 154 141/4672 (3%) 157
Pneumonia bacterial 1/4668 (0%) 1 3/4672 (0.1%) 3
Pneumonia influenzal 2/4668 (0%) 2 1/4672 (0%) 1
Pneumonia legionella 1/4668 (0%) 1 0/4672 (0%) 0
Pneumonia pneumococcal 0/4668 (0%) 0 1/4672 (0%) 1
Pneumonia pseudomonal 0/4668 (0%) 0 1/4672 (0%) 1
Pneumonia staphylococcal 1/4668 (0%) 1 2/4672 (0%) 2
Pneumonia viral 2/4668 (0%) 2 0/4672 (0%) 0
Post procedural cellulitis 1/4668 (0%) 1 0/4672 (0%) 0
Post procedural infection 6/4668 (0.1%) 6 3/4672 (0.1%) 3
Post procedural sepsis 1/4668 (0%) 1 0/4672 (0%) 0
Postoperative abscess 0/4668 (0%) 0 1/4672 (0%) 1
Postoperative wound infection 9/4668 (0.2%) 9 6/4672 (0.1%) 6
Prostatic abscess 0/4668 (0%) 0 1/4672 (0%) 1
Pseudomembranous colitis 0/4668 (0%) 0 2/4672 (0%) 2
Psoas abscess 0/4668 (0%) 0 1/4672 (0%) 1
Pulmonary mycosis 0/4668 (0%) 0 1/4672 (0%) 1
Pulmonary sepsis 2/4668 (0%) 2 3/4672 (0.1%) 3
Pulmonary tuberculosis 1/4668 (0%) 1 1/4672 (0%) 1
Pyelonephritis 9/4668 (0.2%) 9 10/4672 (0.2%) 12
Pyelonephritis acute 6/4668 (0.1%) 9 6/4672 (0.1%) 6
Pyuria 1/4668 (0%) 1 0/4672 (0%) 0
Rectal abscess 1/4668 (0%) 1 0/4672 (0%) 0
Respiratory syncytial virus infection 1/4668 (0%) 1 0/4672 (0%) 0
Respiratory tract infection 2/4668 (0%) 2 7/4672 (0.1%) 10
Respiratory tract infection viral 1/4668 (0%) 1 1/4672 (0%) 1
Salmonella sepsis 1/4668 (0%) 1 0/4672 (0%) 0
Salmonellosis 1/4668 (0%) 1 0/4672 (0%) 0
Scrotal abscess 3/4668 (0.1%) 3 0/4672 (0%) 0
Sepsis 48/4668 (1%) 50 34/4672 (0.7%) 36
Sepsis syndrome 0/4668 (0%) 0 1/4672 (0%) 1
Septic shock 8/4668 (0.2%) 9 13/4672 (0.3%) 13
Sinusitis 1/4668 (0%) 1 0/4672 (0%) 0
Soft tissue infection 3/4668 (0.1%) 3 0/4672 (0%) 0
Staphylococcal bacteraemia 1/4668 (0%) 1 1/4672 (0%) 1
Staphylococcal infection 2/4668 (0%) 2 5/4672 (0.1%) 5
Staphylococcal sepsis 4/4668 (0.1%) 4 0/4672 (0%) 0
Staphylococcal skin infection 1/4668 (0%) 1 0/4672 (0%) 0
Streptococcal bacteraemia 2/4668 (0%) 2 0/4672 (0%) 0
Streptococcal infection 0/4668 (0%) 0 1/4672 (0%) 1
Subcutaneous abscess 2/4668 (0%) 2 0/4672 (0%) 0
Testicular abscess 1/4668 (0%) 1 0/4672 (0%) 0
Tonsillitis 1/4668 (0%) 1 0/4672 (0%) 0
Tooth abscess 0/4668 (0%) 0 5/4672 (0.1%) 5
Tooth infection 0/4668 (0%) 0 1/4672 (0%) 1
Tracheitis 0/4668 (0%) 0 2/4672 (0%) 3
Tracheobronchitis 0/4668 (0%) 0 3/4672 (0.1%) 4
Tuberculosis 0/4668 (0%) 0 1/4672 (0%) 1
Tuberculosis of genitourinary system 1/4668 (0%) 1 0/4672 (0%) 0
Upper respiratory tract infection 4/4668 (0.1%) 4 3/4672 (0.1%) 3
Urinary tract infection 47/4668 (1%) 51 71/4672 (1.5%) 79
Urinary tract infection bacterial 0/4668 (0%) 0 3/4672 (0.1%) 3
Urosepsis 8/4668 (0.2%) 8 17/4672 (0.4%) 19
Vaginal abscess 1/4668 (0%) 1 0/4672 (0%) 0
Vestibular neuronitis 1/4668 (0%) 1 3/4672 (0.1%) 3
Viral infection 5/4668 (0.1%) 5 2/4672 (0%) 2
Viral myocarditis 1/4668 (0%) 1 0/4672 (0%) 0
Viral pharyngitis 1/4668 (0%) 1 0/4672 (0%) 0
Viral sinusitis 1/4668 (0%) 1 0/4672 (0%) 0
Viral upper respiratory tract infection 2/4668 (0%) 2 0/4672 (0%) 0
Wound infection 6/4668 (0.1%) 6 0/4672 (0%) 0
Wound infection staphylococcal 1/4668 (0%) 1 1/4672 (0%) 1
Wound sepsis 0/4668 (0%) 0 1/4672 (0%) 1
Zygomycosis 0/4668 (0%) 0 1/4672 (0%) 1
Injury, poisoning and procedural complications
Abdominal wound dehiscence 1/4668 (0%) 1 0/4672 (0%) 0
Accident 2/4668 (0%) 2 0/4672 (0%) 0
Accidental overdose 5/4668 (0.1%) 5 1/4672 (0%) 1
Acetabulum fracture 0/4668 (0%) 0 1/4672 (0%) 1
Afferent loop syndrome 1/4668 (0%) 1 0/4672 (0%) 0
Anaemia postoperative 1/4668 (0%) 1 0/4672 (0%) 0
Anastomotic ulcer 0/4668 (0%) 0 1/4672 (0%) 1
Ankle fracture 2/4668 (0%) 2 5/4672 (0.1%) 6
Arterial restenosis 1/4668 (0%) 1 0/4672 (0%) 0
Arteriovenous fistula site complication 1/4668 (0%) 1 1/4672 (0%) 4
Arteriovenous fistula thrombosis 1/4668 (0%) 1 0/4672 (0%) 0
Asbestosis 1/4668 (0%) 1 0/4672 (0%) 0
Bladder injury 1/4668 (0%) 1 0/4672 (0%) 0
Brain herniation 0/4668 (0%) 0 1/4672 (0%) 1
Burns second degree 1/4668 (0%) 1 0/4672 (0%) 0
Carbon monoxide poisoning 1/4668 (0%) 1 0/4672 (0%) 0
Cardiac valve replacement complication 1/4668 (0%) 1 0/4672 (0%) 0
Cardiac valve rupture 0/4668 (0%) 0 1/4672 (0%) 1
Carotid artery restenosis 0/4668 (0%) 0 2/4672 (0%) 2
Cataract operation complication 0/4668 (0%) 0 1/4672 (0%) 1
Cataract traumatic 1/4668 (0%) 1 0/4672 (0%) 0
Cervical vertebral fracture 1/4668 (0%) 1 1/4672 (0%) 1
Chest injury 1/4668 (0%) 1 1/4672 (0%) 1
Complications of transplanted kidney 0/4668 (0%) 0 1/4672 (0%) 1
Concussion 1/4668 (0%) 1 5/4672 (0.1%) 5
Contusion 2/4668 (0%) 2 2/4672 (0%) 2
Coronary artery reocclusion 0/4668 (0%) 0 1/4672 (0%) 1
Coronary artery restenosis 5/4668 (0.1%) 5 10/4672 (0.2%) 10
Coronary vascular graft occlusion 1/4668 (0%) 1 3/4672 (0.1%) 3
Craniocerebral injury 1/4668 (0%) 1 1/4672 (0%) 1
Delayed recovery from anaesthesia 1/4668 (0%) 1 0/4672 (0%) 0
Dialysis related complication 1/4668 (0%) 1 0/4672 (0%) 0
Electric shock 1/4668 (0%) 1 0/4672 (0%) 0
Facial bones fracture 0/4668 (0%) 0 1/4672 (0%) 1
Fall 84/4668 (1.8%) 94 81/4672 (1.7%) 83
Fat embolism 0/4668 (0%) 0 1/4672 (0%) 1
Femoral neck fracture 3/4668 (0.1%) 3 4/4672 (0.1%) 4
Femur fracture 6/4668 (0.1%) 6 6/4672 (0.1%) 6
Fibula fracture 2/4668 (0%) 2 1/4672 (0%) 1
Foot fracture 1/4668 (0%) 1 4/4672 (0.1%) 4
Forearm fracture 0/4668 (0%) 0 1/4672 (0%) 1
Fracture displacement 1/4668 (0%) 1 0/4672 (0%) 0
Frostbite 1/4668 (0%) 1 0/4672 (0%) 0
Gun shot wound 0/4668 (0%) 0 1/4672 (0%) 1
Hand fracture 1/4668 (0%) 1 1/4672 (0%) 1
Head injury 4/4668 (0.1%) 4 4/4672 (0.1%) 4
Heat exhaustion 1/4668 (0%) 1 0/4672 (0%) 0
Hip fracture 5/4668 (0.1%) 6 4/4672 (0.1%) 4
Human bite 1/4668 (0%) 1 0/4672 (0%) 0
Humerus fracture 1/4668 (0%) 1 3/4672 (0.1%) 4
Incisional hernia 4/4668 (0.1%) 4 3/4672 (0.1%) 3
Incorrect dose administered 2/4668 (0%) 2 1/4672 (0%) 1
Inflammation of wound 1/4668 (0%) 1 0/4672 (0%) 0
Injury 1/4668 (0%) 1 2/4672 (0%) 2
Intentional overdose 2/4668 (0%) 2 0/4672 (0%) 0
Jaw fracture 0/4668 (0%) 0 2/4672 (0%) 2
Joint dislocation 4/4668 (0.1%) 5 2/4672 (0%) 6
Joint injury 2/4668 (0%) 2 2/4672 (0%) 3
Laceration 1/4668 (0%) 1 0/4672 (0%) 0
Ligament rupture 2/4668 (0%) 2 1/4672 (0%) 1
Ligament sprain 2/4668 (0%) 2 0/4672 (0%) 0
Limb injury 1/4668 (0%) 1 1/4672 (0%) 1
Limb traumatic amputation 1/4668 (0%) 1 0/4672 (0%) 0
Lower limb fracture 1/4668 (0%) 1 3/4672 (0.1%) 3
Lumbar vertebral fracture 1/4668 (0%) 1 1/4672 (0%) 1
Meniscus injury 3/4668 (0.1%) 3 4/4672 (0.1%) 4
Multiple fractures 0/4668 (0%) 0 1/4672 (0%) 1
Muscle rupture 0/4668 (0%) 0 1/4672 (0%) 1
Muscle strain 0/4668 (0%) 0 1/4672 (0%) 1
Overdose 2/4668 (0%) 2 0/4672 (0%) 0
Peripheral arterial reocclusion 1/4668 (0%) 1 0/4672 (0%) 0
Peripheral artery restenosis 0/4668 (0%) 0 3/4672 (0.1%) 4
Post laminectomy syndrome 1/4668 (0%) 1 0/4672 (0%) 0
Post procedural fistula 0/4668 (0%) 0 1/4672 (0%) 1
Post procedural haematoma 3/4668 (0.1%) 3 0/4672 (0%) 0
Post procedural haematuria 1/4668 (0%) 1 1/4672 (0%) 1
Post procedural haemorrhage 2/4668 (0%) 2 3/4672 (0.1%) 4
Post procedural hypothyroidism 0/4668 (0%) 0 1/4672 (0%) 1
Post procedural myocardial infarction 0/4668 (0%) 0 6/4672 (0.1%) 6
Post procedural pulmonary embolism 1/4668 (0%) 1 0/4672 (0%) 0
Post procedural stroke 0/4668 (0%) 0 1/4672 (0%) 1
Post-traumatic pain 1/4668 (0%) 1 0/4672 (0%) 0
Postoperative fever 1/4668 (0%) 1 0/4672 (0%) 0
Postoperative hernia 1/4668 (0%) 1 0/4672 (0%) 0
Postoperative respiratory failure 2/4668 (0%) 2 1/4672 (0%) 1
Postoperative thoracic procedure complication 2/4668 (0%) 3 0/4672 (0%) 0
Postoperative thrombosis 1/4668 (0%) 1 0/4672 (0%) 0
Postoperative wound complication 3/4668 (0.1%) 3 1/4672 (0%) 1
Procedural haemorrhage 1/4668 (0%) 1 0/4672 (0%) 0
Procedural hypotension 1/4668 (0%) 1 0/4672 (0%) 0
Procedural intestinal perforation 0/4668 (0%) 0 1/4672 (0%) 1
Procedural pain 2/4668 (0%) 2 1/4672 (0%) 1
Radiation pneumonitis 0/4668 (0%) 0 1/4672 (0%) 1
Radius fracture 0/4668 (0%) 0 2/4672 (0%) 2
Respiratory fume inhalation disorder 0/4668 (0%) 0 1/4672 (0%) 1
Rib fracture 2/4668 (0%) 2 4/4672 (0.1%) 4
Road traffic accident 20/4668 (0.4%) 23 16/4672 (0.3%) 16
Scapula fracture 1/4668 (0%) 1 0/4672 (0%) 0
Seroma 1/4668 (0%) 1 0/4672 (0%) 0
Shunt occlusion 0/4668 (0%) 0 1/4672 (0%) 1
Skeletal injury 0/4668 (0%) 0 1/4672 (0%) 1
Soft tissue injury 1/4668 (0%) 1 0/4672 (0%) 0
Spinal compression fracture 0/4668 (0%) 0 3/4672 (0.1%) 3
Spinal cord injury thoracic 0/4668 (0%) 0 1/4672 (0%) 1
Spinal fracture 0/4668 (0%) 0 1/4672 (0%) 1
Splenic rupture 0/4668 (0%) 0 1/4672 (0%) 1
Stab wound 0/4668 (0%) 0 1/4672 (0%) 1
Sternal fracture 0/4668 (0%) 0 1/4672 (0%) 1
Subcutaneous haematoma 1/4668 (0%) 1 0/4672 (0%) 0
Subdural haematoma 5/4668 (0.1%) 6 10/4672 (0.2%) 10
Subdural haemorrhage 1/4668 (0%) 2 0/4672 (0%) 0
Tendon rupture 3/4668 (0.1%) 3 4/4672 (0.1%) 4
Thermal burn 2/4668 (0%) 2 0/4672 (0%) 0
Tibia fracture 1/4668 (0%) 1 2/4672 (0%) 2
Toxicity to various agents 4/4668 (0.1%) 4 1/4672 (0%) 1
Tracheostomy malfunction 1/4668 (0%) 1 0/4672 (0%) 0
Traumatic arthritis 1/4668 (0%) 1 1/4672 (0%) 1
Traumatic arthrosis 0/4668 (0%) 0 1/4672 (0%) 1
Traumatic haematoma 1/4668 (0%) 1 0/4672 (0%) 0
Traumatic intracranial haemorrhage 0/4668 (0%) 0 1/4672 (0%) 1
Traumatic ulcer 0/4668 (0%) 0 1/4672 (0%) 1
Ulna fracture 2/4668 (0%) 2 1/4672 (0%) 1
Urinary retention postoperative 0/4668 (0%) 0 1/4672 (0%) 1
Vascular graft occlusion 3/4668 (0.1%) 3 6/4672 (0.1%) 7
Vascular graft thrombosis 2/4668 (0%) 3 2/4672 (0%) 2
Vascular pseudoaneurysm 1/4668 (0%) 1 1/4672 (0%) 1
Wound 1/4668 (0%) 4 2/4672 (0%) 2
Wound decomposition 1/4668 (0%) 1 0/4672 (0%) 0
Wound dehiscence 0/4668 (0%) 0 1/4672 (0%) 1
Wound haemorrhage 1/4668 (0%) 1 0/4672 (0%) 0
Wound necrosis 0/4668 (0%) 0 1/4672 (0%) 1
Wrist fracture 1/4668 (0%) 1 0/4672 (0%) 0
Wrong drug administered 1/4668 (0%) 1 0/4672 (0%) 0
Investigations
Ammonia increased 0/4668 (0%) 0 1/4672 (0%) 1
Amylase increased 5/4668 (0.1%) 5 2/4672 (0%) 2
Angiogram peripheral 1/4668 (0%) 1 0/4672 (0%) 0
Arteriogram coronary 0/4668 (0%) 0 7/4672 (0.1%) 7
Blood alcohol increased 0/4668 (0%) 0 1/4672 (0%) 1
Blood calcitonin increased 0/4668 (0%) 0 3/4672 (0.1%) 3
Blood creatine phosphokinase increased 1/4668 (0%) 1 0/4672 (0%) 0
Blood creatinine increased 6/4668 (0.1%) 6 3/4672 (0.1%) 3
Blood glucose fluctuation 1/4668 (0%) 1 1/4672 (0%) 1
Blood glucose increased 8/4668 (0.2%) 8 8/4672 (0.2%) 11
Blood iron decreased 1/4668 (0%) 1 0/4672 (0%) 0
Blood magnesium decreased 1/4668 (0%) 1 0/4672 (0%) 0
Blood potassium decreased 0/4668 (0%) 0 1/4672 (0%) 1
Blood potassium increased 2/4668 (0%) 2 1/4672 (0%) 1
Blood pressure decreased 1/4668 (0%) 1 0/4672 (0%) 0
Blood pressure increased 1/4668 (0%) 1 3/4672 (0.1%) 3
Blood pressure systolic increased 0/4668 (0%) 0 1/4672 (0%) 1
Blood urea increased 1/4668 (0%) 1 1/4672 (0%) 1
Blood urine present 0/4668 (0%) 0 1/4672 (0%) 1
Cardiac murmur 1/4668 (0%) 1 0/4672 (0%) 0
Cardiac stress test abnormal 0/4668 (0%) 0 1/4672 (0%) 1
Cardiovascular evaluation 2/4668 (0%) 2 2/4672 (0%) 2
Catheterisation cardiac 2/4668 (0%) 2 2/4672 (0%) 2
Colonoscopy 0/4668 (0%) 0 1/4672 (0%) 1
Colonoscopy normal 0/4668 (0%) 0 1/4672 (0%) 1
Culture urine positive 1/4668 (0%) 1 0/4672 (0%) 0
ECG signs of myocardial ischaemia 1/4668 (0%) 1 1/4672 (0%) 1
Ejection fraction decreased 1/4668 (0%) 1 2/4672 (0%) 2
Electrocardiogram QT prolonged 1/4668 (0%) 1 3/4672 (0.1%) 3
Gamma-glutamyltransferase increased 1/4668 (0%) 1 0/4672 (0%) 0
Glomerular filtration rate decreased 1/4668 (0%) 1 0/4672 (0%) 0
Glycosylated haemoglobin increased 1/4668 (0%) 1 1/4672 (0%) 1
Haemoglobin decreased 0/4668 (0%) 0 1/4672 (0%) 1
Heart rate decreased 0/4668 (0%) 0 1/4672 (0%) 1
Heart rate increased 0/4668 (0%) 0 1/4672 (0%) 1
Hepatic enzyme increased 0/4668 (0%) 0 1/4672 (0%) 1
Imaging procedure 1/4668 (0%) 1 0/4672 (0%) 0
Inflammatory marker increased 0/4668 (0%) 0 2/4672 (0%) 2
International normalised ratio decreased 1/4668 (0%) 1 0/4672 (0%) 0
International normalised ratio increased 3/4668 (0.1%) 3 6/4672 (0.1%) 6
Left ventricular end-diastolic pressure increased 0/4668 (0%) 0 1/4672 (0%) 1
Lipase increased 11/4668 (0.2%) 11 3/4672 (0.1%) 3
Liver function test abnormal 1/4668 (0%) 1 0/4672 (0%) 0
Myocardial necrosis marker increased 0/4668 (0%) 0 1/4672 (0%) 1
Pancreatic enzymes increased 1/4668 (0%) 1 0/4672 (0%) 0
Prostatic specific antigen increased 1/4668 (0%) 1 1/4672 (0%) 1
Red blood cell sedimentation rate increased 0/4668 (0%) 0 1/4672 (0%) 1
Renal function test 1/4668 (0%) 1 0/4672 (0%) 0
Serum ferritin decreased 1/4668 (0%) 1 0/4672 (0%) 0
Transplant evaluation 0/4668 (0%) 0 1/4672 (0%) 1
Troponin increased 0/4668 (0%) 0 1/4672 (0%) 1
Urine albumin/creatinine ratio increased 1/4668 (0%) 1 0/4672 (0%) 0
Weight decreased 1/4668 (0%) 1 3/4672 (0.1%) 3
Weight increased 0/4668 (0%) 0 1/4672 (0%) 1
Metabolism and nutrition disorders
Cachexia 1/4668 (0%) 1 0/4672 (0%) 0
Cell death 1/4668 (0%) 1 0/4672 (0%) 0
Decreased appetite 4/4668 (0.1%) 4 1/4672 (0%) 1
Dehydration 30/4668 (0.6%) 30 22/4672 (0.5%) 22
Diabetes mellitus 3/4668 (0.1%) 3 11/4672 (0.2%) 12
Diabetes mellitus inadequate control 25/4668 (0.5%) 28 43/4672 (0.9%) 47
Diabetic complication 0/4668 (0%) 0 1/4672 (0%) 1
Diabetic ketoacidosis 11/4668 (0.2%) 12 7/4672 (0.1%) 8
Dyslipidaemia 1/4668 (0%) 1 0/4672 (0%) 0
Electrolyte imbalance 1/4668 (0%) 1 0/4672 (0%) 0
Failure to thrive 3/4668 (0.1%) 4 0/4672 (0%) 0
Fluid overload 8/4668 (0.2%) 8 4/4672 (0.1%) 6
Fluid retention 0/4668 (0%) 0 1/4672 (0%) 1
Gout 4/4668 (0.1%) 8 6/4672 (0.1%) 6
Hypercalcaemia 1/4668 (0%) 1 0/4672 (0%) 0
Hyperglycaemia 34/4668 (0.7%) 35 49/4672 (1%) 52
Hyperkalaemia 9/4668 (0.2%) 10 15/4672 (0.3%) 15
Hyperlipidaemia 0/4668 (0%) 0 2/4672 (0%) 2
Hyperosmolar hyperglycaemic state 3/4668 (0.1%) 3 6/4672 (0.1%) 6
Hypervolaemia 2/4668 (0%) 2 0/4672 (0%) 0
Hypocalcaemia 0/4668 (0%) 0 1/4672 (0%) 1
Hypoglycaemia 44/4668 (0.9%) 60 75/4672 (1.6%) 92
Hypokalaemia 7/4668 (0.1%) 8 7/4672 (0.1%) 7
Hypomagnesaemia 0/4668 (0%) 0 2/4672 (0%) 2
Hyponatraemia 4/4668 (0.1%) 4 6/4672 (0.1%) 6
Hypovolaemia 1/4668 (0%) 1 3/4672 (0.1%) 3
Insulin-requiring type 2 diabetes mellitus 1/4668 (0%) 1 0/4672 (0%) 0
Iron deficiency 1/4668 (0%) 1 3/4672 (0.1%) 3
Ketoacidosis 1/4668 (0%) 1 0/4672 (0%) 0
Lactic acidosis 2/4668 (0%) 2 0/4672 (0%) 0
Malnutrition 1/4668 (0%) 1 0/4672 (0%) 0
Metabolic acidosis 1/4668 (0%) 1 2/4672 (0%) 2
Metabolic disorder 1/4668 (0%) 1 1/4672 (0%) 1
Metabolic syndrome 0/4668 (0%) 0 1/4672 (0%) 3
Obesity 8/4668 (0.2%) 8 11/4672 (0.2%) 11
Type 2 diabetes mellitus 1/4668 (0%) 1 0/4672 (0%) 0
Vitamin B12 deficiency 1/4668 (0%) 1 0/4672 (0%) 0
Musculoskeletal and connective tissue disorders
Acquired claw toe 1/4668 (0%) 1 0/4672 (0%) 0
Arthralgia 10/4668 (0.2%) 10 13/4672 (0.3%) 14
Arthritis 16/4668 (0.3%) 17 5/4672 (0.1%) 5
Arthritis reactive 0/4668 (0%) 0 1/4672 (0%) 1
Arthropathy 1/4668 (0%) 1 0/4672 (0%) 0
Back disorder 0/4668 (0%) 0 1/4672 (0%) 1
Back pain 14/4668 (0.3%) 14 20/4672 (0.4%) 21
Bursitis 3/4668 (0.1%) 3 1/4672 (0%) 1
Cervical spinal stenosis 2/4668 (0%) 2 3/4672 (0.1%) 3
Compartment syndrome 0/4668 (0%) 0 2/4672 (0%) 2
Costochondritis 2/4668 (0%) 2 1/4672 (0%) 1
Diastasis recti abdominis 0/4668 (0%) 0 1/4672 (0%) 1
Dupuytren's contracture 4/4668 (0.1%) 4 0/4672 (0%) 0
Fibromyalgia 3/4668 (0.1%) 3 0/4672 (0%) 0
Foot deformity 1/4668 (0%) 1 2/4672 (0%) 2
Fracture nonunion 0/4668 (0%) 0 1/4672 (0%) 1
Gouty arthritis 2/4668 (0%) 2 1/4672 (0%) 1
Groin pain 0/4668 (0%) 0 1/4672 (0%) 1
Haemarthrosis 1/4668 (0%) 1 1/4672 (0%) 1
Intervertebral disc degeneration 4/4668 (0.1%) 4 4/4672 (0.1%) 4
Intervertebral disc disorder 1/4668 (0%) 1 0/4672 (0%) 0
Intervertebral disc displacement 1/4668 (0%) 1 0/4672 (0%) 0
Intervertebral disc protrusion 13/4668 (0.3%) 14 23/4672 (0.5%) 27
Joint swelling 1/4668 (0%) 1 0/4672 (0%) 0
Lumbar spinal stenosis 11/4668 (0.2%) 12 9/4672 (0.2%) 9
Meniscal degeneration 1/4668 (0%) 1 0/4672 (0%) 0
Mobility decreased 1/4668 (0%) 1 1/4672 (0%) 1
Muscle haemorrhage 0/4668 (0%) 0 1/4672 (0%) 1
Muscle spasms 0/4668 (0%) 0 1/4672 (0%) 1
Muscular weakness 2/4668 (0%) 2 1/4672 (0%) 1
Musculoskeletal chest pain 7/4668 (0.1%) 7 9/4672 (0.2%) 9
Musculoskeletal pain 5/4668 (0.1%) 5 2/4672 (0%) 2
Myositis 0/4668 (0%) 0 1/4672 (0%) 1
Neck pain 0/4668 (0%) 0 1/4672 (0%) 1
Neuropathic arthropathy 1/4668 (0%) 1 1/4672 (0%) 1
Osteitis deformans 0/4668 (0%) 0 1/4672 (0%) 1
Osteoarthritis 75/4668 (1.6%) 80 64/4672 (1.4%) 69
Osteochondrosis 1/4668 (0%) 1 2/4672 (0%) 2
Osteolysis 1/4668 (0%) 1 0/4672 (0%) 0
Osteonecrosis 0/4668 (0%) 0 3/4672 (0.1%) 3
Osteoporotic fracture 0/4668 (0%) 0 1/4672 (0%) 1
Pain in extremity 7/4668 (0.1%) 7 1/4672 (0%) 1
Pathological fracture 0/4668 (0%) 0 1/4672 (0%) 1
Periarthritis 5/4668 (0.1%) 5 0/4672 (0%) 0
Polyarthritis 2/4668 (0%) 2 0/4672 (0%) 0
Polymyalgia rheumatica 1/4668 (0%) 1 4/4672 (0.1%) 4
Rhabdomyolysis 1/4668 (0%) 1 1/4672 (0%) 1
Rheumatoid arthritis 2/4668 (0%) 2 1/4672 (0%) 1
Rotator cuff syndrome 5/4668 (0.1%) 5 7/4672 (0.1%) 7
Sacroiliitis 1/4668 (0%) 1 0/4672 (0%) 0
Spinal column stenosis 7/4668 (0.1%) 7 10/4672 (0.2%) 10
Spinal instability 1/4668 (0%) 1 0/4672 (0%) 0
Spinal osteoarthritis 9/4668 (0.2%) 9 8/4672 (0.2%) 8
Spinal pain 1/4668 (0%) 1 0/4672 (0%) 0
Spondylolisthesis 3/4668 (0.1%) 3 1/4672 (0%) 1
Synovial cyst 2/4668 (0%) 2 1/4672 (0%) 1
Synovitis 0/4668 (0%) 0 1/4672 (0%) 1
Tendonitis 3/4668 (0.1%) 3 0/4672 (0%) 0
Trigger finger 1/4668 (0%) 1 1/4672 (0%) 1
Ulnocarpal abutment syndrome 0/4668 (0%) 0 1/4672 (0%) 1
Vertebral foraminal stenosis 0/4668 (0%) 0 3/4672 (0.1%) 4
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia 2/4668 (0%) 2 2/4672 (0%) 2
Adenocarcinoma 0/4668 (0%) 0 3/4672 (0.1%) 3
Adenocarcinoma gastric 3/4668 (0.1%) 3 3/4672 (0.1%) 3
Adenocarcinoma of colon 14/4668 (0.3%) 15 11/4672 (0.2%) 11
Adenocarcinoma of the cervix 1/4668 (0%) 1 0/4672 (0%) 0
Adenocarcinoma pancreas 4/4668 (0.1%) 4 1/4672 (0%) 1
Adrenal adenoma 2/4668 (0%) 2 2/4672 (0%) 2
Adrenal neoplasm 2/4668 (0%) 2 2/4672 (0%) 2
Anal squamous cell carcinoma 0/4668 (0%) 0 1/4672 (0%) 1
Angiomyolipoma 0/4668 (0%) 0 1/4672 (0%) 1
B-cell lymphoma 2/4668 (0%) 2 2/4672 (0%) 2
B-cell unclassifiable lymphoma low grade 0/4668 (0%) 0 1/4672 (0%) 1
Basal cell carcinoma 14/4668 (0.3%) 17 7/4672 (0.1%) 7
Basosquamous carcinoma 1/4668 (0%) 1 1/4672 (0%) 1
Benign anorectal neoplasm 1/4668 (0%) 1 0/4672 (0%) 0
Benign breast neoplasm 1/4668 (0%) 1 0/4672 (0%) 0
Benign neoplasm of bladder 1/4668 (0%) 1 0/4672 (0%) 0
Benign neoplasm of prostate 1/4668 (0%) 1 0/4672 (0%) 0
Benign neoplasm of thyroid gland 0/4668 (0%) 0 1/4672 (0%) 1
Benign ovarian tumour 1/4668 (0%) 1 0/4672 (0%) 0
Benign soft tissue neoplasm 1/4668 (0%) 1 0/4672 (0%) 0
Biliary adenoma 0/4668 (0%) 0 1/4672 (0%) 1
Bladder cancer 3/4668 (0.1%) 3 5/4672 (0.1%) 5
Bladder cancer recurrent 1/4668 (0%) 1 1/4672 (0%) 1
Bladder cancer stage 0, with cancer in situ 1/4668 (0%) 1 0/4672 (0%) 0
Bladder cancer stage III 0/4668 (0%) 0 1/4672 (0%) 1
Bladder neoplasm 1/4668 (0%) 1 3/4672 (0.1%) 3
Bladder squamous cell carcinoma stage unspecified 1/4668 (0%) 1 0/4672 (0%) 0
Bladder transitional cell carcinoma 4/4668 (0.1%) 4 5/4672 (0.1%) 5
Bladder transitional cell carcinoma recurrent 1/4668 (0%) 1 0/4672 (0%) 0
Bladder transitional cell carcinoma stage III 0/4668 (0%) 0 1/4672 (0%) 1
Blepharal papilloma 0/4668 (0%) 0 1/4672 (0%) 1
Bone neoplasm 1/4668 (0%) 1 0/4672 (0%) 0
Bowen's disease 1/4668 (0%) 1 2/4672 (0%) 2
Brain neoplasm 1/4668 (0%) 1 1/4672 (0%) 1
Breast cancer 6/4668 (0.1%) 6 6/4672 (0.1%) 6
Breast cancer female 1/4668 (0%) 1 0/4672 (0%) 0
Breast cancer in situ 1/4668 (0%) 1 0/4672 (0%) 0
Breast cancer metastatic 1/4668 (0%) 1 1/4672 (0%) 1
Bronchial carcinoma 3/4668 (0.1%) 3 2/4672 (0%) 2
Carcinoid tumour of the small bowel 0/4668 (0%) 0 1/4672 (0%) 1
Carcinoid tumour pulmonary 1/4668 (0%) 1 0/4672 (0%) 0
Central nervous system lymphoma 1/4668 (0%) 1 0/4672 (0%) 0
Cerebellar tumour 0/4668 (0%) 0 1/4672 (0%) 1
Cerebral haemangioma 0/4668 (0%) 0 1/4672 (0%) 1
Cholangiocarcinoma 5/4668 (0.1%) 5 3/4672 (0.1%) 3
Cholesteatoma 1/4668 (0%) 1 0/4672 (0%) 0
Cholesterol granuloma 1/4668 (0%) 1 0/4672 (0%) 0
Chondrosarcoma metastatic 0/4668 (0%) 0 1/4672 (0%) 1
Chondrosarcoma recurrent 1/4668 (0%) 1 0/4672 (0%) 0
Chronic lymphocytic leukaemia 1/4668 (0%) 1 3/4672 (0.1%) 3
Chronic lymphocytic leukaemia stage 1 0/4668 (0%) 0 1/4672 (0%) 1
Chronic myeloid leukaemia 1/4668 (0%) 1 1/4672 (0%) 1
Chronic myelomonocytic leukaemia 0/4668 (0%) 0 1/4672 (0%) 1
Clear cell renal cell carcinoma 6/4668 (0.1%) 6 3/4672 (0.1%) 3
Colon adenoma 13/4668 (0.3%) 14 16/4672 (0.3%) 18
Colon cancer 3/4668 (0.1%) 3 6/4672 (0.1%) 6
Colon cancer metastatic 3/4668 (0.1%) 3 1/4672 (0%) 1
Colon cancer stage 0 1/4668 (0%) 1 0/4672 (0%) 0
Colorectal adenocarcinoma 0/4668 (0%) 0 1/4672 (0%) 1
Colorectal cancer 0/4668 (0%) 0 1/4672 (0%) 1
Diffuse large B-cell lymphoma 1/4668 (0%) 1 0/4672 (0%) 0
Endometrial adenocarcinoma 0/4668 (0%) 0 2/4672 (0%) 2
Extranodal marginal zone B-cell lymphoma (MALT type) 1/4668 (0%) 1 0/4672 (0%) 0
Follicle centre lymphoma, follicular grade I, II, III stage I 0/4668 (0%) 0 1/4672 (0%) 1
Follicle centre lymphoma, follicular grade I, II, III stage IV 1/4668 (0%) 1 0/4672 (0%) 0
Gallbladder adenocarcinoma 1/4668 (0%) 1 0/4672 (0%) 0
Gastric cancer 0/4668 (0%) 0 1/4672 (0%) 1
Gastric cancer stage III 0/4668 (0%) 0 1/4672 (0%) 1
Gastrointestinal stromal tumour 0/4668 (0%) 0 2/4672 (0%) 2
Gastrointestinal tract adenoma 1/4668 (0%) 1 2/4672 (0%) 2
Giant cell tumour of tendon sheath 1/4668 (0%) 1 0/4672 (0%) 0
Glioblastoma 2/4668 (0%) 2 1/4672 (0%) 1
Glioblastoma multiforme 2/4668 (0%) 2 0/4672 (0%) 0
Glomus tumour 1/4668 (0%) 1 0/4672 (0%) 0
Haemangioma 1/4668 (0%) 1 1/4672 (0%) 1
Haemangioma of bone 0/4668 (0%) 0 1/4672 (0%) 2
Haemangioma of spleen 0/4668 (0%) 0 1/4672 (0%) 1
Hairy cell leukaemia 0/4668 (0%) 0 1/4672 (0%) 1
Hepatic cancer 3/4668 (0.1%) 3 1/4672 (0%) 1
Hepatic cancer metastatic 1/4668 (0%) 1 1/4672 (0%) 1
Hepatocellular carcinoma 5/4668 (0.1%) 5 4/4672 (0.1%) 4
Hypopharyngeal cancer 0/4668 (0%) 0 1/4672 (0%) 1
Intraductal papillary mucinous neoplasm 1/4668 (0%) 1 2/4672 (0%) 2
Intraductal proliferative breast lesion 2/4668 (0%) 2 3/4672 (0.1%) 3
Invasive breast carcinoma 0/4668 (0%) 0 1/4672 (0%) 1
Invasive ductal breast carcinoma 11/4668 (0.2%) 11 9/4672 (0.2%) 9
Invasive lobular breast carcinoma 1/4668 (0%) 1 2/4672 (0%) 2
Keratoacanthoma 0/4668 (0%) 0 1/4672 (0%) 1
Large cell lung cancer 1/4668 (0%) 1 0/4672 (0%) 0
Large granular lymphocytosis 0/4668 (0%) 0 1/4672 (0%) 1
Large intestine benign neoplasm 1/4668 (0%) 2 1/4672 (0%) 1
Laryngeal cancer 1/4668 (0%) 1 1/4672 (0%) 1
Laryngeal cancer stage I 1/4668 (0%) 1 0/4672 (0%) 0
Laryngeal squamous cell carcinoma 1/4668 (0%) 1 1/4672 (0%) 1
Lip squamous cell carcinoma 0/4668 (0%) 0 1/4672 (0%) 1
Lipoma 2/4668 (0%) 2 1/4672 (0%) 1
Liposarcoma 0/4668 (0%) 0 1/4672 (0%) 1
Liposarcoma metastatic 1/4668 (0%) 1 0/4672 (0%) 0
Lung adenocarcinoma 6/4668 (0.1%) 6 3/4672 (0.1%) 3
Lung adenocarcinoma metastatic 1/4668 (0%) 1 3/4672 (0.1%) 3
Lung adenocarcinoma stage IV 0/4668 (0%) 0 1/4672 (0%) 1
Lung cancer metastatic 3/4668 (0.1%) 3 2/4672 (0%) 2
Lung carcinoma cell type unspecified stage III 1/4668 (0%) 1 0/4672 (0%) 0
Lung neoplasm 2/4668 (0%) 2 0/4672 (0%) 0
Lung neoplasm malignant 2/4668 (0%) 2 9/4672 (0.2%) 10
Lung squamous cell carcinoma stage III 0/4668 (0%) 0 2/4672 (0%) 2
Lung squamous cell carcinoma stage IV 1/4668 (0%) 1 0/4672 (0%) 0
Malignant glioma 1/4668 (0%) 1 0/4672 (0%) 0
Malignant melanoma 8/4668 (0.2%) 8 6/4672 (0.1%) 6
Malignant melanoma in situ 2/4668 (0%) 2 0/4672 (0%) 0
Malignant neoplasm of pleura 0/4668 (0%) 0 1/4672 (0%) 1
Medullary thyroid cancer 0/4668 (0%) 0 1/4672 (0%) 1
Melanocytic naevus 2/4668 (0%) 2 0/4672 (0%) 0
Meningioma 2/4668 (0%) 2 2/4672 (0%) 2
Meningioma benign 0/4668 (0%) 0 1/4672 (0%) 1
Mesothelioma malignant 1/4668 (0%) 1 0/4672 (0%) 0
Metastases to bone 2/4668 (0%) 2 1/4672 (0%) 1
Metastases to central nervous system 2/4668 (0%) 2 2/4672 (0%) 2
Metastases to liver 5/4668 (0.1%) 6 4/4672 (0.1%) 4
Metastases to lung 3/4668 (0.1%) 3 2/4672 (0%) 2
Metastases to lymph nodes 1/4668 (0%) 1 0/4672 (0%) 0
Metastases to peritoneum 1/4668 (0%) 1 2/4672 (0%) 2
Metastases to spine 0/4668 (0%) 0 1/4672 (0%) 1
Metastatic bronchial carcinoma 0/4668 (0%) 0 1/4672 (0%) 1
Metastatic malignant melanoma 2/4668 (0%) 2 2/4672 (0%) 2
Metastatic neoplasm 2/4668 (0%) 2 0/4672 (0%) 0
Metastatic renal cell carcinoma 1/4668 (0%) 1 1/4672 (0%) 1
Metastatic squamous cell carcinoma 0/4668 (0%) 0 2/4672 (0%) 2
Mucinous breast carcinoma 1/4668 (0%) 1 1/4672 (0%) 1
Myelodysplastic syndrome 0/4668 (0%) 0 2/4672 (0%) 2
Myxofibrosarcoma 0/4668 (0%) 0 1/4672 (0%) 1
Neoplasm 1/4668 (0%) 1 0/4672 (0%) 0
Neoplasm of appendix 1/4668 (0%) 1 0/4672 (0%) 0
Neoplasm skin 2/4668 (0%) 2 0/4672 (0%) 0
Neuroendocrine carcinoma of the skin 0/4668 (0%) 0 1/4672 (0%) 1
Non-Hodgkin's lymphoma 3/4668 (0.1%) 3 2/4672 (0%) 2
Non-Hodgkin's lymphoma recurrent 1/4668 (0%) 1 0/4672 (0%) 0
Non-Hodgkin's lymphoma stage III 0/4668 (0%) 0 1/4672 (0%) 1
Non-small cell lung cancer 4/4668 (0.1%) 4 2/4672 (0%) 2
Non-small cell lung cancer metastatic 1/4668 (0%) 1 1/4672 (0%) 1
Non-small cell lung cancer stage I 0/4668 (0%) 0 1/4672 (0%) 1
Oesophageal adenocarcinoma 3/4668 (0.1%) 3 0/4672 (0%) 0
Oesophageal adenocarcinoma metastatic 1/4668 (0%) 1 1/4672 (0%) 1
Oesophageal cancer metastatic 0/4668 (0%) 0 1/4672 (0%) 1
Oesophageal squamous cell carcinoma 0/4668 (0%) 0 3/4672 (0.1%) 3
Oesophageal squamous cell carcinoma stage IV 0/4668 (0%) 0 1/4672 (0%) 1
Oropharyngeal cancer stage IV 1/4668 (0%) 1 0/4672 (0%) 0
Ovarian adenoma 0/4668 (0%) 0 1/4672 (0%) 1
Ovarian cancer 2/4668 (0%) 2 0/4672 (0%) 0
Ovarian cancer metastatic 0/4668 (0%) 0 1/4672 (0%) 1
Ovarian epithelial cancer 0/4668 (0%) 0 1/4672 (0%) 1
Ovarian epithelial cancer metastatic 0/4668 (0%) 0 1/4672 (0%) 1
Pancreatic carcinoma 4/4668 (0.1%) 4 7/4672 (0.1%) 7
Pancreatic carcinoma metastatic 2/4668 (0%) 2 2/4672 (0%) 2
Pancreatic carcinoma stage IV 1/4668 (0%) 1 0/4672 (0%) 0
Pancreatic neoplasm 2/4668 (0%) 2 0/4672 (0%) 0
Papillary cystadenoma lymphomatosum 1/4668 (0%) 1 2/4672 (0%) 2
Papillary serous endometrial carcinoma 0/4668 (0%) 0 1/4672 (0%) 1
Papillary thyroid cancer 4/4668 (0.1%) 5 3/4672 (0.1%) 3
Parathyroid tumour benign 3/4668 (0.1%) 3 2/4672 (0%) 2
Pelvic neoplasm 1/4668 (0%) 1 0/4672 (0%) 0
Phyllodes tumour 0/4668 (0%) 0 1/4672 (0%) 1
Pituitary tumour benign 1/4668 (0%) 1 0/4672 (0%) 0
Plasma cell myeloma 3/4668 (0.1%) 3 5/4672 (0.1%) 5
Plasmacytoma 0/4668 (0%) 0 1/4672 (0%) 1
Pleural mesothelioma 1/4668 (0%) 1 0/4672 (0%) 0
Prostate cancer 24/4668 (0.5%) 24 39/4672 (0.8%) 39
Prostate cancer metastatic 2/4668 (0%) 2 4/4672 (0.1%) 4
Prostate cancer recurrent 1/4668 (0%) 1 0/4672 (0%) 0
Prostate cancer stage II 0/4668 (0%) 0 1/4672 (0%) 1
Rectal adenocarcinoma 6/4668 (0.1%) 6 3/4672 (0.1%) 3
Rectal adenoma 1/4668 (0%) 1 2/4672 (0%) 2
Rectal cancer 4/4668 (0.1%) 4 3/4672 (0.1%) 3
Rectal cancer metastatic 1/4668 (0%) 1 1/4672 (0%) 1
Rectal cancer stage II 1/4668 (0%) 1 0/4672 (0%) 0
Renal cancer 1/4668 (0%) 1 2/4672 (0%) 2
Renal cancer metastatic 1/4668 (0%) 1 0/4672 (0%) 0
Renal cancer recurrent 1/4668 (0%) 1 0/4672 (0%) 0
Renal cell carcinoma 2/4668 (0%) 2 5/4672 (0.1%) 5
Renal cell carcinoma stage II 1/4668 (0%) 1 0/4672 (0%) 0
Renal neoplasm 1/4668 (0%) 1 2/4672 (0%) 2
Salivary gland neoplasm 1/4668 (0%) 1 0/4672 (0%) 0
Seborrhoeic keratosis 2/4668 (0%) 2 1/4672 (0%) 1
Skin cancer 1/4668 (0%) 1 0/4672 (0%) 0
Small cell lung cancer 2/4668 (0%) 2 2/4672 (0%) 2
Small cell lung cancer metastatic 3/4668 (0.1%) 3 1/4672 (0%) 1
Small intestine carcinoma 1/4668 (0%) 1 0/4672 (0%) 0
Small intestine carcinoma metastatic 1/4668 (0%) 1 0/4672 (0%) 0
Squamous cell carcinoma 4/4668 (0.1%) 4 2/4672 (0%) 2
Squamous cell carcinoma of lung 1/4668 (0%) 1 5/4672 (0.1%) 5
Squamous cell carcinoma of skin 7/4668 (0.1%) 8 2/4672 (0%) 2
Squamous cell carcinoma of the cervix 4/4668 (0.1%) 5 0/4672 (0%) 0
Squamous cell carcinoma of the oral cavity 1/4668 (0%) 1 1/4672 (0%) 1
Squamous cell carcinoma of the tongue 1/4668 (0%) 1 1/4672 (0%) 1
Squamous cell carcinoma of the vulva 1/4668 (0%) 1 1/4672 (0%) 1
Thyroid adenoma 0/4668 (0%) 0 2/4672 (0%) 2
Thyroid cancer 0/4668 (0%) 0 1/4672 (0%) 1
Thyroid neoplasm 4/4668 (0.1%) 4 3/4672 (0.1%) 3
Tonsil cancer 1/4668 (0%) 1 0/4672 (0%) 0
Transitional cell carcinoma 8/4668 (0.2%) 8 3/4672 (0.1%) 3
Transitional cell carcinoma metastatic 1/4668 (0%) 1 0/4672 (0%) 0
Urinary tract neoplasm 1/4668 (0%) 1 0/4672 (0%) 0
Uterine leiomyoma 2/4668 (0%) 2 3/4672 (0.1%) 3
Uterine leiomyosarcoma 0/4668 (0%) 0 1/4672 (0%) 1
Vocal cord neoplasm 1/4668 (0%) 1 0/4672 (0%) 0
Vulval neoplasm 0/4668 (0%) 0 1/4672 (0%) 1
Nervous system disorders
Altered state of consciousness 0/4668 (0%) 0 1/4672 (0%) 1
Ataxia 2/4668 (0%) 2 1/4672 (0%) 1
Autonomic nervous system imbalance 1/4668 (0%) 1 0/4672 (0%) 0
Basal ganglia haemorrhage 1/4668 (0%) 1 1/4672 (0%) 1
Basal ganglia stroke 1/4668 (0%) 1 0/4672 (0%) 0
Brain injury 0/4668 (0%) 0 2/4672 (0%) 2
Brain oedema 0/4668 (0%) 0 1/4672 (0%) 1
Brain stem infarction 1/4668 (0%) 1 1/4672 (0%) 1
Carotid arteriosclerosis 1/4668 (0%) 1 1/4672 (0%) 1
Carotid artery aneurysm 2/4668 (0%) 2 0/4672 (0%) 0
Carotid artery disease 0/4668 (0%) 0 1/4672 (0%) 1
Carotid artery occlusion 3/4668 (0.1%) 3 2/4672 (0%) 2
Carotid artery stenosis 28/4668 (0.6%) 30 16/4672 (0.3%) 18
Carpal tunnel syndrome 6/4668 (0.1%) 7 4/4672 (0.1%) 4
Cauda equina syndrome 0/4668 (0%) 0 1/4672 (0%) 1
Cerebellar haematoma 0/4668 (0%) 0 1/4672 (0%) 1
Cerebellar infarction 1/4668 (0%) 1 2/4672 (0%) 2
Cerebellar ischaemia 1/4668 (0%) 1 0/4672 (0%) 0
Cerebral haematoma 0/4668 (0%) 0 1/4672 (0%) 1
Cerebral haemorrhage 4/4668 (0.1%) 4 5/4672 (0.1%) 5
Cerebral hypoperfusion 1/4668 (0%) 1 0/4672 (0%) 0
Cerebral infarction 14/4668 (0.3%) 14 20/4672 (0.4%) 21
Cerebral ischaemia 3/4668 (0.1%) 3 3/4672 (0.1%) 3
Cerebral small vessel ischaemic disease 3/4668 (0.1%) 3 0/4672 (0%) 0
Cerebrovascular accident 52/4668 (1.1%) 56 65/4672 (1.4%) 68
Cerebrovascular insufficiency 0/4668 (0%) 0 2/4672 (0%) 2
Cervical myelopathy 1/4668 (0%) 1 0/4672 (0%) 0
Cervical radiculopathy 1/4668 (0%) 1 1/4672 (0%) 1
Chronic inflammatory demyelinating polyradiculoneuropathy 0/4668 (0%) 0 1/4672 (0%) 1
Cognitive disorder 4/4668 (0.1%) 4 3/4672 (0.1%) 4
Coma 0/4668 (0%) 0 2/4672 (0%) 3
Dementia 3/4668 (0.1%) 3 3/4672 (0.1%) 3
Dementia Alzheimer's type 2/4668 (0%) 2 0/4672 (0%) 0
Dementia with Lewy bodies 0/4668 (0%) 0 1/4672 (0%) 1
Depressed level of consciousness 1/4668 (0%) 1 0/4672 (0%) 0
Diabetic mononeuropathy 0/4668 (0%) 0 1/4672 (0%) 1
Diabetic neuropathy 9/4668 (0.2%) 10 7/4672 (0.1%) 12
Dizziness 12/4668 (0.3%) 12 6/4672 (0.1%) 6
Dysarthria 1/4668 (0%) 1 0/4672 (0%) 0
Dyskinesia 0/4668 (0%) 0 1/4672 (0%) 2
Embolic cerebral infarction 1/4668 (0%) 1 0/4672 (0%) 0
Embolic stroke 5/4668 (0.1%) 6 1/4672 (0%) 1
Encephalopathy 1/4668 (0%) 1 2/4672 (0%) 2
Epilepsy 4/4668 (0.1%) 5 2/4672 (0%) 3
Generalised tonic-clonic seizure 2/4668 (0%) 2 1/4672 (0%) 1
Guillain-Barre syndrome 0/4668 (0%) 0 1/4672 (0%) 1
Haemorrhage intracranial 6/4668 (0.1%) 6 3/4672 (0.1%) 4
Haemorrhagic cerebral infarction 1/4668 (0%) 1 1/4672 (0%) 1
Haemorrhagic stroke 10/4668 (0.2%) 10 13/4672 (0.3%) 13
Headache 2/4668 (0%) 2 7/4672 (0.1%) 7
Hemiparesis 1/4668 (0%) 1 0/4672 (0%) 0
Hemiplegia 1/4668 (0%) 3 1/4672 (0%) 1
Hepatic encephalopathy 3/4668 (0.1%) 3 0/4672 (0%) 0
Hydrocephalus 0/4668 (0%) 0 2/4672 (0%) 2
Hyperaesthesia 1/4668 (0%) 1 0/4672 (0%) 0
Hypertensive encephalopathy 0/4668 (0%) 0 2/4672 (0%) 2
Hypoaesthesia 1/4668 (0%) 1 0/4672 (0%) 0
Hypoglycaemic coma 1/4668 (0%) 1 2/4672 (0%) 2
Hypoglycaemic seizure 2/4668 (0%) 2 0/4672 (0%) 0
Hypoglycaemic unconsciousness 21/4668 (0.4%) 24 28/4672 (0.6%) 28
Hypoxic-ischaemic encephalopathy 2/4668 (0%) 2 4/4672 (0.1%) 5
IIIrd nerve disorder 0/4668 (0%) 0 1/4672 (0%) 1
Intercostal neuralgia 1/4668 (0%) 1 1/4672 (0%) 1
Internal carotid artery kinking 1/4668 (0%) 2 0/4672 (0%) 0
Intracranial aneurysm 1/4668 (0%) 1 0/4672 (0%) 0
Ischaemic cerebral infarction 2/4668 (0%) 3 4/4672 (0.1%) 4
Ischaemic stroke 50/4668 (1.1%) 54 54/4672 (1.2%) 59
Lacunar infarction 6/4668 (0.1%) 7 8/4672 (0.2%) 8
Lethargy 1/4668 (0%) 1 0/4672 (0%) 0
Loss of consciousness 5/4668 (0.1%) 6 7/4672 (0.1%) 7
Lumbar radiculopathy 4/4668 (0.1%) 4 1/4672 (0%) 1
Memory impairment 1/4668 (0%) 1 0/4672 (0%) 0
Metabolic encephalopathy 6/4668 (0.1%) 6 0/4672 (0%) 0
Migraine 0/4668 (0%) 0 4/4672 (0.1%) 4
Mononeuropathy 0/4668 (0%) 0 1/4672 (0%) 1
Multiple system atrophy 1/4668 (0%) 1 0/4672 (0%) 0
Myasthenia gravis 1/4668 (0%) 1 0/4672 (0%) 0
Myelopathy 0/4668 (0%) 0 1/4672 (0%) 1
Nerve compression 0/4668 (0%) 0 2/4672 (0%) 2
Nervous system disorder 0/4668 (0%) 0 2/4672 (0%) 2
Neuralgia 0/4668 (0%) 0 1/4672 (0%) 1
Neuritis cranial 0/4668 (0%) 0 1/4672 (0%) 1
Neuropathy peripheral 3/4668 (0.1%) 3 1/4672 (0%) 1
Normal pressure hydrocephalus 0/4668 (0%) 0 1/4672 (0%) 1
Orthostatic intolerance 1/4668 (0%) 1 0/4672 (0%) 0
Paraplegia 1/4668 (0%) 1 0/4672 (0%) 0
Parkinson's disease 1/4668 (0%) 1 2/4672 (0%) 2
Parkinsonism 1/4668 (0%) 1 1/4672 (0%) 1
Partial seizures 0/4668 (0%) 0 1/4672 (0%) 1
Peripheral nerve lesion 1/4668 (0%) 1 0/4672 (0%) 0
Peroneal nerve palsy 0/4668 (0%) 0 1/4672 (0%) 1
Petit mal epilepsy 1/4668 (0%) 1 0/4672 (0%) 0
Polyneuropathy 2/4668 (0%) 2 2/4672 (0%) 2
Post herpetic neuralgia 0/4668 (0%) 0 1/4672 (0%) 1
Post-traumatic headache 1/4668 (0%) 2 0/4672 (0%) 0
Presyncope 6/4668 (0.1%) 7 6/4672 (0.1%) 6
Radiculopathy 0/4668 (0%) 0 1/4672 (0%) 1
Restless legs syndrome 2/4668 (0%) 2 0/4672 (0%) 0
Reversible ischaemic neurological deficit 0/4668 (0%) 0 1/4672 (0%) 1
Sciatica 4/4668 (0.1%) 4 3/4672 (0.1%) 3
Seizure 7/4668 (0.1%) 7 6/4672 (0.1%) 6
Seizure like phenomena 0/4668 (0%) 0 1/4672 (0%) 1
Serotonin syndrome 1/4668 (0%) 1 0/4672 (0%) 0
Spinal claudication 1/4668 (0%) 1 0/4672 (0%) 0
Status epilepticus 0/4668 (0%) 0 1/4672 (0%) 1
Subarachnoid haemorrhage 4/4668 (0.1%) 4 3/4672 (0.1%) 3
Syncope 39/4668 (0.8%) 43 26/4672 (0.6%) 27
Tension headache 0/4668 (0%) 0 1/4672 (0%) 1
Thalamic infarction 3/4668 (0.1%) 3 0/4672 (0%) 0
Thrombotic cerebral infarction 1/4668 (0%) 1 0/4672 (0%) 0
Thrombotic stroke 3/4668 (0.1%) 3 0/4672 (0%) 0
Toxic encephalopathy 0/4668 (0%) 0 1/4672 (0%) 1
Transient ischaemic attack 52/4668 (1.1%) 57 68/4672 (1.5%) 73
Unresponsive to stimuli 1/4668 (0%) 1 0/4672 (0%) 0
Uraemic encephalopathy 2/4668 (0%) 2 0/4672 (0%) 0
VIIth nerve paralysis 3/4668 (0.1%) 3 5/4672 (0.1%) 6
Vascular dementia 1/4668 (0%) 1 2/4672 (0%) 2
Vertebral artery stenosis 0/4668 (0%) 0 1/4672 (0%) 1
Vertebrobasilar insufficiency 1/4668 (0%) 1 3/4672 (0.1%) 3
Vocal cord paralysis 1/4668 (0%) 1 0/4672 (0%) 0
Psychiatric disorders
Alcohol abuse 1/4668 (0%) 2 1/4672 (0%) 1
Alcoholism 1/4668 (0%) 1 1/4672 (0%) 1
Anxiety 2/4668 (0%) 2 2/4672 (0%) 2
Bipolar disorder 3/4668 (0.1%) 5 2/4672 (0%) 3
Completed suicide 1/4668 (0%) 1 4/4672 (0.1%) 4
Confusional state 0/4668 (0%) 0 9/4672 (0.2%) 9
Delirium 1/4668 (0%) 1 3/4672 (0.1%) 3
Depression 9/4668 (0.2%) 11 7/4672 (0.1%) 7
Disorientation 1/4668 (0%) 2 0/4672 (0%) 0
Major depression 1/4668 (0%) 1 4/4672 (0.1%) 5
Mania 1/4668 (0%) 1 0/4672 (0%) 0
Mental disorder 1/4668 (0%) 2 1/4672 (0%) 1
Mental status changes 3/4668 (0.1%) 3 3/4672 (0.1%) 4
Personality disorder 1/4668 (0%) 1 0/4672 (0%) 0
Somatisation disorder 1/4668 (0%) 1 0/4672 (0%) 0
Suicidal ideation 1/4668 (0%) 1 1/4672 (0%) 1
Suicide attempt 4/4668 (0.1%) 4 2/4672 (0%) 2
Renal and urinary disorders
Acute kidney injury 108/4668 (2.3%) 124 94/4672 (2%) 105
Acute prerenal failure 1/4668 (0%) 1 1/4672 (0%) 1
Azotaemia 3/4668 (0.1%) 3 2/4672 (0%) 2
Bladder diverticulum 0/4668 (0%) 0 1/4672 (0%) 1
Bladder dysplasia 1/4668 (0%) 1 0/4672 (0%) 0
Bladder hypertrophy 0/4668 (0%) 0 2/4672 (0%) 2
Bladder neck obstruction 2/4668 (0%) 2 0/4672 (0%) 0
Bladder outlet obstruction 0/4668 (0%) 0 1/4672 (0%) 1
Bladder prolapse 3/4668 (0.1%) 3 1/4672 (0%) 1
Bladder stenosis 1/4668 (0%) 1 0/4672 (0%) 0
Calculus bladder 1/4668 (0%) 1 0/4672 (0%) 0
Calculus ureteric 10/4668 (0.2%) 10 9/4672 (0.2%) 9
Calculus urinary 2/4668 (0%) 2 2/4672 (0%) 2
Chronic kidney disease 52/4668 (1.1%) 60 52/4672 (1.1%) 55
Diabetic nephropathy 6/4668 (0.1%) 7 11/4672 (0.2%) 11
Dysuria 1/4668 (0%) 1 3/4672 (0.1%) 3
Fibrillary glomerulonephritis 1/4668 (0%) 1 0/4672 (0%) 0
Focal segmental glomerulosclerosis 0/4668 (0%) 0 1/4672 (0%) 1
Glomerulonephritis membranous 1/4668 (0%) 2 0/4672 (0%) 0
Glomerulosclerosis 1/4668 (0%) 1 0/4672 (0%) 0
Haematuria 7/4668 (0.1%) 7 2/4672 (0%) 2
Haemorrhage urinary tract 1/4668 (0%) 2 0/4672 (0%) 0
Hydronephrosis 5/4668 (0.1%) 6 2/4672 (0%) 2
Mesangioproliferative glomerulonephritis 0/4668 (0%) 0 1/4672 (0%) 1
Microalbuminuria 1/4668 (0%) 1 0/4672 (0%) 0
Nephritis 1/4668 (0%) 1 0/4672 (0%) 0
Nephrolithiasis 26/4668 (0.6%) 27 21/4672 (0.4%) 22
Nephropathy 6/4668 (0.1%) 6 13/4672 (0.3%) 15
Nephropathy toxic 1/4668 (0%) 1 2/4672 (0%) 2
Nephrotic syndrome 2/4668 (0%) 2 1/4672 (0%) 1
Nocturia 0/4668 (0%) 0 1/4672 (0%) 1
Obstructive uropathy 2/4668 (0%) 2 0/4672 (0%) 0
Pelvi-ureteric obstruction 1/4668 (0%) 1 0/4672 (0%) 0
Polyuria 0/4668 (0%) 0 1/4672 (0%) 1
Proteinuria 2/4668 (0%) 2 3/4672 (0.1%) 3
Renal artery arteriosclerosis 0/4668 (0%) 0 1/4672 (0%) 1
Renal artery occlusion 0/4668 (0%) 0 1/4672 (0%) 1
Renal artery stenosis 2/4668 (0%) 2 3/4672 (0.1%) 3
Renal colic 3/4668 (0.1%) 3 1/4672 (0%) 1
Renal cyst 5/4668 (0.1%) 5 11/4672 (0.2%) 11
Renal failure 20/4668 (0.4%) 21 31/4672 (0.7%) 33
Renal haemorrhage 2/4668 (0%) 2 0/4672 (0%) 0
Renal impairment 14/4668 (0.3%) 14 10/4672 (0.2%) 10
Renal infarct 1/4668 (0%) 1 0/4672 (0%) 0
Renal injury 0/4668 (0%) 0 1/4672 (0%) 1
Renal pain 1/4668 (0%) 1 0/4672 (0%) 0
Renal tubular necrosis 1/4668 (0%) 1 5/4672 (0.1%) 5
Single functional kidney 1/4668 (0%) 1 0/4672 (0%) 0
Stress urinary incontinence 1/4668 (0%) 1 0/4672 (0%) 0
Tubulointerstitial nephritis 1/4668 (0%) 1 3/4672 (0.1%) 3
Ureteral necrosis 1/4668 (0%) 1 0/4672 (0%) 0
Ureteral polyp 0/4668 (0%) 0 1/4672 (0%) 1
Ureteric obstruction 1/4668 (0%) 1 0/4672 (0%) 0
Ureteric stenosis 1/4668 (0%) 1 0/4672 (0%) 0
Urethral stenosis 4/4668 (0.1%) 4 6/4672 (0.1%) 7
Urinary bladder polyp 0/4668 (0%) 0 2/4672 (0%) 2
Urinary incontinence 2/4668 (0%) 2 1/4672 (0%) 1
Urinary retention 8/4668 (0.2%) 8 12/4672 (0.3%) 13
Urinary tract obstruction 1/4668 (0%) 1 1/4672 (0%) 1
Reproductive system and breast disorders
Acquired phimosis 0/4668 (0%) 0 1/4672 (0%) 1
Benign prostatic hyperplasia 25/4668 (0.5%) 25 23/4672 (0.5%) 23
Breast mass 2/4668 (0%) 2 0/4672 (0%) 0
Cervical dysplasia 1/4668 (0%) 1 0/4672 (0%) 0
Cervical polyp 1/4668 (0%) 1 0/4672 (0%) 0
Cystocele 2/4668 (0%) 2 0/4672 (0%) 0
Endometrial hyperplasia 2/4668 (0%) 2 0/4672 (0%) 0
Erectile dysfunction 3/4668 (0.1%) 3 0/4672 (0%) 0
Genital prolapse 1/4668 (0%) 1 0/4672 (0%) 0
Haematospermia 1/4668 (0%) 1 0/4672 (0%) 0
Ovarian cyst 1/4668 (0%) 1 2/4672 (0%) 2
Peyronie's disease 1/4668 (0%) 1 0/4672 (0%) 0
Postmenopausal haemorrhage 0/4668 (0%) 0 1/4672 (0%) 1
Prostatic dysplasia 1/4668 (0%) 2 0/4672 (0%) 0
Prostatitis 7/4668 (0.1%) 7 2/4672 (0%) 2
Prostatomegaly 3/4668 (0.1%) 3 1/4672 (0%) 1
Testicular cyst 1/4668 (0%) 1 0/4672 (0%) 0
Testicular mass 0/4668 (0%) 0 1/4672 (0%) 1
Testicular necrosis 0/4668 (0%) 0 1/4672 (0%) 1
Uterine polyp 1/4668 (0%) 1 6/4672 (0.1%) 6
Uterine prolapse 3/4668 (0.1%) 3 0/4672 (0%) 0
Vaginal fistula 0/4668 (0%) 0 1/4672 (0%) 1
Vaginal haemorrhage 2/4668 (0%) 2 2/4672 (0%) 2
Vaginal prolapse 0/4668 (0%) 0 1/4672 (0%) 1
Respiratory, thoracic and mediastinal disorders
Acute interstitial pneumonitis 0/4668 (0%) 0 1/4672 (0%) 1
Acute pulmonary oedema 13/4668 (0.3%) 15 10/4672 (0.2%) 13
Acute respiratory distress syndrome 2/4668 (0%) 2 3/4672 (0.1%) 3
Acute respiratory failure 22/4668 (0.5%) 23 18/4672 (0.4%) 21
Asphyxia 0/4668 (0%) 0 2/4672 (0%) 2
Aspiration 1/4668 (0%) 1 1/4672 (0%) 1
Asthma 12/4668 (0.3%) 14 14/4672 (0.3%) 23
Asthmatic crisis 0/4668 (0%) 0 1/4672 (0%) 1
Atelectasis 0/4668 (0%) 0 1/4672 (0%) 1
Bronchial hyperreactivity 1/4668 (0%) 1 1/4672 (0%) 1
Bronchiectasis 0/4668 (0%) 0 2/4672 (0%) 2
Bronchitis chronic 0/4668 (0%) 0 1/4672 (0%) 1
Bronchopneumopathy 1/4668 (0%) 1 0/4672 (0%) 0
Bronchospasm 2/4668 (0%) 6 1/4672 (0%) 1
Chronic obstructive pulmonary disease 50/4668 (1.1%) 68 59/4672 (1.3%) 82
Chronic respiratory failure 0/4668 (0%) 0 1/4672 (0%) 1
Dependence on respirator 0/4668 (0%) 0 1/4672 (0%) 1
Dyspnoea 20/4668 (0.4%) 21 32/4672 (0.7%) 36
Dyspnoea exertional 6/4668 (0.1%) 6 7/4672 (0.1%) 7
Emphysema 1/4668 (0%) 1 3/4672 (0.1%) 3
Epistaxis 8/4668 (0.2%) 8 3/4672 (0.1%) 3
Haemoptysis 3/4668 (0.1%) 3 1/4672 (0%) 1
Haemothorax 0/4668 (0%) 0 1/4672 (0%) 1
Hepatopulmonary syndrome 1/4668 (0%) 1 0/4672 (0%) 0
Hypercapnia 1/4668 (0%) 1 0/4672 (0%) 0
Hypoxia 5/4668 (0.1%) 5 3/4672 (0.1%) 3
Idiopathic pulmonary fibrosis 0/4668 (0%) 0 1/4672 (0%) 1
Interstitial lung disease 3/4668 (0.1%) 3 1/4672 (0%) 1
Laryngeal dysplasia 0/4668 (0%) 0 1/4672 (0%) 1
Laryngeal oedema 1/4668 (0%) 1 1/4672 (0%) 1
Laryngeal stenosis 1/4668 (0%) 1 1/4672 (0%) 1
Lung infiltration 1/4668 (0%) 1 2/4672 (0%) 2
Nasal polyps 0/4668 (0%) 0 2/4672 (0%) 2
Nasal septum deviation 1/4668 (0%) 1 0/4672 (0%) 0
Nasopharyngeal polyp 0/4668 (0%) 0 1/4672 (0%) 1
Non-cardiogenic pulmonary oedema 0/4668 (0%) 0 1/4672 (0%) 1
Obstructive airways disorder 0/4668 (0%) 0 1/4672 (0%) 1
Organising pneumonia 2/4668 (0%) 2 1/4672 (0%) 1
Paranasal cyst 1/4668 (0%) 1 0/4672 (0%) 0
Pharyngeal cyst 0/4668 (0%) 0 1/4672 (0%) 1
Pharyngeal inflammation 0/4668 (0%) 0 1/4672 (0%) 1
Pleural effusion 4/4668 (0.1%) 4 15/4672 (0.3%) 18
Pleurisy 1/4668 (0%) 1 2/4672 (0%) 2
Pleuritic pain 2/4668 (0%) 2 1/4672 (0%) 1
Pneumonia aspiration 7/4668 (0.1%) 7 6/4672 (0.1%) 7
Pneumonitis 0/4668 (0%) 0 1/4672 (0%) 1
Pneumothorax 1/4668 (0%) 1 2/4672 (0%) 2
Pulmonary cavitation 2/4668 (0%) 2 0/4672 (0%) 0
Pulmonary congestion 0/4668 (0%) 0 2/4672 (0%) 2
Pulmonary embolism 21/4668 (0.4%) 21 24/4672 (0.5%) 26
Pulmonary fibrosis 1/4668 (0%) 2 3/4672 (0.1%) 4
Pulmonary hypertension 3/4668 (0.1%) 3 4/4672 (0.1%) 5
Pulmonary mass 3/4668 (0.1%) 3 6/4672 (0.1%) 8
Pulmonary oedema 17/4668 (0.4%) 22 21/4672 (0.4%) 25
Pulmonary sarcoidosis 1/4668 (0%) 1 0/4672 (0%) 0
Respiratory arrest 2/4668 (0%) 2 0/4672 (0%) 0
Respiratory distress 5/4668 (0.1%) 5 0/4672 (0%) 0
Respiratory failure 18/4668 (0.4%) 20 19/4672 (0.4%) 21
Restrictive pulmonary disease 0/4668 (0%) 0 1/4672 (0%) 1
Rhinitis allergic 0/4668 (0%) 0 1/4672 (0%) 1
Rhinitis hypertrophic 1/4668 (0%) 1 0/4672 (0%) 0
Sinus polyp 1/4668 (0%) 1 0/4672 (0%) 0
Sleep apnoea syndrome 9/4668 (0.2%) 9 7/4672 (0.1%) 7
Status asthmaticus 1/4668 (0%) 1 0/4672 (0%) 0
Upper airway obstruction 1/4668 (0%) 1 0/4672 (0%) 0
Vocal cord polyp 0/4668 (0%) 0 1/4672 (0%) 1
Skin and subcutaneous tissue disorders
Actinic elastosis 0/4668 (0%) 0 1/4672 (0%) 1
Actinic keratosis 4/4668 (0.1%) 5 1/4672 (0%) 1
Alopecia areata 0/4668 (0%) 0 1/4672 (0%) 1
Angioedema 6/4668 (0.1%) 8 7/4672 (0.1%) 7
Chronic pigmented purpura 1/4668 (0%) 1 0/4672 (0%) 0
Chronic spontaneous urticaria 1/4668 (0%) 1 0/4672 (0%) 0
Decubitus ulcer 1/4668 (0%) 1 1/4672 (0%) 1
Dermatitis 0/4668 (0%) 0 1/4672 (0%) 1
Dermatitis contact 0/4668 (0%) 0 1/4672 (0%) 1
Diabetic foot 66/4668 (1.4%) 88 80/4672 (1.7%) 94
Diabetic neuropathic ulcer 1/4668 (0%) 1 0/4672 (0%) 0
Diabetic ulcer 1/4668 (0%) 4 2/4672 (0%) 2
Eczema 0/4668 (0%) 0 1/4672 (0%) 1
Haemorrhage subcutaneous 1/4668 (0%) 1 0/4672 (0%) 0
Keloid scar 1/4668 (0%) 1 0/4672 (0%) 0
Lichen sclerosus 1/4668 (0%) 1 0/4672 (0%) 0
Lividity 1/4668 (0%) 2 0/4672 (0%) 0
Melanocytic hyperplasia 1/4668 (0%) 1 0/4672 (0%) 0
Nail bed inflammation 1/4668 (0%) 1 0/4672 (0%) 0
Necrobiosis lipoidica diabeticorum 1/4668 (0%) 1 0/4672 (0%) 0
Neurodermatitis 1/4668 (0%) 1 0/4672 (0%) 0
Neuropathic ulcer 3/4668 (0.1%) 3 0/4672 (0%) 0
Parapsoriasis 0/4668 (0%) 0 2/4672 (0%) 2
Pemphigoid 0/4668 (0%) 0 1/4672 (0%) 1
Psoriasis 2/4668 (0%) 2 1/4672 (0%) 2
Skin lesion 1/4668 (0%) 1 2/4672 (0%) 2
Skin necrosis 1/4668 (0%) 1 0/4672 (0%) 0
Skin ulcer 10/4668 (0.2%) 10 15/4672 (0.3%) 15
Stasis dermatitis 1/4668 (0%) 1 1/4672 (0%) 1
Toxic epidermal necrolysis 0/4668 (0%) 0 1/4672 (0%) 1
Urticaria papular 0/4668 (0%) 0 1/4672 (0%) 1
Social circumstances
Social stay hospitalisation 0/4668 (0%) 0 1/4672 (0%) 1
Walking disability 0/4668 (0%) 0 1/4672 (0%) 1
Surgical and medical procedures
Abdominal panniculectomy 0/4668 (0%) 0 1/4672 (0%) 1
Abdominoplasty 1/4668 (0%) 1 0/4672 (0%) 0
Angioplasty 7/4668 (0.1%) 8 11/4672 (0.2%) 12
Ankle operation 0/4668 (0%) 0 1/4672 (0%) 1
Aortic aneurysm repair 0/4668 (0%) 0 1/4672 (0%) 1
Aortic bypass 2/4668 (0%) 2 1/4672 (0%) 2
Aortic surgery 1/4668 (0%) 1 0/4672 (0%) 0
Arterial repair 1/4668 (0%) 1 0/4672 (0%) 0
Arterial stent insertion 0/4668 (0%) 0 1/4672 (0%) 1
Arterial therapeutic procedure 1/4668 (0%) 1 0/4672 (0%) 0
Arteriovenous fistula operation 0/4668 (0%) 0 2/4672 (0%) 3
Atherectomy 1/4668 (0%) 2 0/4672 (0%) 0
Cardiac ablation 1/4668 (0%) 1 0/4672 (0%) 0
Cardiac pacemaker battery replacement 1/4668 (0%) 1 0/4672 (0%) 0
Cardiac pacemaker removal 1/4668 (0%) 1 0/4672 (0%) 0
Cardiac pacemaker replacement 1/4668 (0%) 1 3/4672 (0.1%) 3
Cardiac resynchronisation therapy 1/4668 (0%) 1 1/4672 (0%) 1
Cardiopulmonary bypass 1/4668 (0%) 1 0/4672 (0%) 0
Cardiovascular event prophylaxis 1/4668 (0%) 1 0/4672 (0%) 0
Carotid angioplasty 5/4668 (0.1%) 5 0/4672 (0%) 0
Carotid artery bypass 1/4668 (0%) 1 0/4672 (0%) 0
Carotid artery stent insertion 6/4668 (0.1%) 6 2/4672 (0%) 2
Carotid endarterectomy 19/4668 (0.4%) 23 14/4672 (0.3%) 14
Carotid revascularisation 6/4668 (0.1%) 6 2/4672 (0%) 2
Cataract operation 2/4668 (0%) 4 0/4672 (0%) 0
Cerebral revascularisation 0/4668 (0%) 0 1/4672 (0%) 1
Cholecystectomy 1/4668 (0%) 1 1/4672 (0%) 1
Colostomy closure 1/4668 (0%) 1 0/4672 (0%) 0
Coronary angioplasty 46/4668 (1%) 56 39/4672 (0.8%) 42
Coronary arterial stent insertion 110/4668 (2.4%) 117 112/4672 (2.4%) 136
Coronary artery bypass 84/4668 (1.8%) 86 102/4672 (2.2%) 105
Coronary revascularisation 120/4668 (2.6%) 144 132/4672 (2.8%) 157
Deep brain stimulation 1/4668 (0%) 1 0/4672 (0%) 0
Endarterectomy 0/4668 (0%) 0 3/4672 (0.1%) 3
Gastric banding 1/4668 (0%) 1 1/4672 (0%) 1
Gastric bypass 1/4668 (0%) 1 1/4672 (0%) 1
Gastroplasty 0/4668 (0%) 0 1/4672 (0%) 1
Hip arthroplasty 0/4668 (0%) 0 1/4672 (0%) 1
Hospitalisation 0/4668 (0%) 0 1/4672 (0%) 1
Implantable defibrillator insertion 2/4668 (0%) 2 5/4672 (0.1%) 5
Implantable defibrillator replacement 1/4668 (0%) 1 1/4672 (0%) 1
Inguinal hernia repair 2/4668 (0%) 2 0/4672 (0%) 0
Ischaemic heart disease prophylaxis 1/4668 (0%) 1 0/4672 (0%) 0
Joint arthroplasty 0/4668 (0%) 0 1/4672 (0%) 1
Knee arthroplasty 0/4668 (0%) 0 1/4672 (0%) 1
Knee operation 1/4668 (0%) 1 0/4672 (0%) 0
Lipoma excision 0/4668 (0%) 0 1/4672 (0%) 1
Medical device battery replacement 0/4668 (0%) 0 1/4672 (0%) 1
Medical device change 0/4668 (0%) 0 1/4672 (0%) 1
Mitral valve replacement 0/4668 (0%) 0 1/4672 (0%) 1
Obesity surgery 1/4668 (0%) 1 1/4672 (0%) 1
Parathyroidectomy 1/4668 (0%) 1 0/4672 (0%) 0
Pelvic floor repair 0/4668 (0%) 0 1/4672 (0%) 1
Percutaneous coronary intervention 59/4668 (1.3%) 71 57/4672 (1.2%) 66
Peripheral artery angioplasty 20/4668 (0.4%) 25 27/4672 (0.6%) 29
Peripheral artery bypass 11/4668 (0.2%) 12 14/4672 (0.3%) 19
Peripheral artery stent insertion 7/4668 (0.1%) 10 9/4672 (0.2%) 10
Peripheral endarterectomy 6/4668 (0.1%) 7 2/4672 (0%) 2
Peripheral revascularisation 29/4668 (0.6%) 33 36/4672 (0.8%) 47
Prophylaxis against dehydration 0/4668 (0%) 0 1/4672 (0%) 1
Rehabilitation therapy 1/4668 (0%) 1 1/4672 (0%) 1
Renal artery stent placement 0/4668 (0%) 0 3/4672 (0.1%) 3
Renal revascularisation surgery 2/4668 (0%) 2 0/4672 (0%) 0
Skin graft 1/4668 (0%) 1 0/4672 (0%) 0
Spinal decompression 1/4668 (0%) 1 0/4672 (0%) 0
Stent placement 3/4668 (0.1%) 3 4/4672 (0.1%) 4
Thrombectomy 0/4668 (0%) 0 4/4672 (0.1%) 5
Vascular graft 1/4668 (0%) 1 1/4672 (0%) 1
Vascular operation 0/4668 (0%) 0 1/4672 (0%) 1
Vascular stent insertion 1/4668 (0%) 1 0/4672 (0%) 0
Wrist surgery 0/4668 (0%) 0 1/4672 (0%) 1
Vascular disorders
Accelerated hypertension 1/4668 (0%) 1 4/4672 (0.1%) 4
Air embolism 1/4668 (0%) 1 0/4672 (0%) 0
Aortic aneurysm 8/4668 (0.2%) 8 5/4672 (0.1%) 5
Aortic aneurysm rupture 0/4668 (0%) 0 1/4672 (0%) 1
Aortic arteriosclerosis 1/4668 (0%) 1 0/4672 (0%) 0
Aortic dissection 3/4668 (0.1%) 3 0/4672 (0%) 0
Aortic occlusion 1/4668 (0%) 1 0/4672 (0%) 0
Aortic stenosis 11/4668 (0.2%) 11 7/4672 (0.1%) 7
Arteriosclerosis 3/4668 (0.1%) 3 5/4672 (0.1%) 5
Blood pressure fluctuation 1/4668 (0%) 1 0/4672 (0%) 0
Blood pressure inadequately controlled 1/4668 (0%) 1 0/4672 (0%) 0
Circulatory collapse 4/4668 (0.1%) 5 6/4672 (0.1%) 6
Deep vein thrombosis 20/4668 (0.4%) 23 10/4672 (0.2%) 11
Diabetic vascular disorder 2/4668 (0%) 2 1/4672 (0%) 1
Dry gangrene 2/4668 (0%) 2 1/4672 (0%) 1
Extremity necrosis 4/4668 (0.1%) 4 1/4672 (0%) 1
Femoral artery occlusion 6/4668 (0.1%) 7 5/4672 (0.1%) 5
Granulomatosis with polyangiitis 1/4668 (0%) 1 0/4672 (0%) 0
Haematoma 1/4668 (0%) 1 2/4672 (0%) 2
Haemorrhage 1/4668 (0%) 1 2/4672 (0%) 2
Hypertension 32/4668 (0.7%) 36 25/4672 (0.5%) 27
Hypertensive crisis 14/4668 (0.3%) 18 12/4672 (0.3%) 13
Hypertensive emergency 2/4668 (0%) 2 0/4672 (0%) 0
Hypotension 18/4668 (0.4%) 18 16/4672 (0.3%) 17
Hypovolaemic shock 2/4668 (0%) 2 5/4672 (0.1%) 5
Iliac artery occlusion 1/4668 (0%) 1 0/4672 (0%) 0
Intermittent claudication 5/4668 (0.1%) 7 3/4672 (0.1%) 3
Internal haemorrhage 1/4668 (0%) 1 0/4672 (0%) 0
Labile hypertension 1/4668 (0%) 1 1/4672 (0%) 1
Leriche syndrome 0/4668 (0%) 0 1/4672 (0%) 1
Lymphocele 1/4668 (0%) 1 1/4672 (0%) 1
Lymphoedema 1/4668 (0%) 2 1/4672 (0%) 1
Malignant hypertension 0/4668 (0%) 0 3/4672 (0.1%) 3
Microangiopathy 1/4668 (0%) 1 0/4672 (0%) 0
Necrosis ischaemic 1/4668 (0%) 1 0/4672 (0%) 0
Neurogenic shock 0/4668 (0%) 0 1/4672 (0%) 1
Orthostatic hypotension 10/4668 (0.2%) 10 8/4672 (0.2%) 8
Penetrating atherosclerotic ulcer 0/4668 (0%) 0 1/4672 (0%) 1
Peripheral arterial occlusive disease 24/4668 (0.5%) 27 34/4672 (0.7%) 38
Peripheral artery aneurysm 2/4668 (0%) 2 1/4672 (0%) 1
Peripheral artery stenosis 8/4668 (0.2%) 9 12/4672 (0.3%) 19
Peripheral artery thrombosis 4/4668 (0.1%) 5 4/4672 (0.1%) 5
Peripheral circulatory failure 1/4668 (0%) 1 0/4672 (0%) 0
Peripheral ischaemia 13/4668 (0.3%) 14 11/4672 (0.2%) 12
Peripheral vascular disorder 10/4668 (0.2%) 11 8/4672 (0.2%) 9
Peripheral venous disease 0/4668 (0%) 0 1/4672 (0%) 1
Phlebitis 1/4668 (0%) 1 0/4672 (0%) 0
Phlebosclerosis 1/4668 (0%) 1 0/4672 (0%) 0
Shock 1/4668 (0%) 1 0/4672 (0%) 0
Shock haemorrhagic 5/4668 (0.1%) 5 0/4672 (0%) 0
Steal syndrome 0/4668 (0%) 0 1/4672 (0%) 1
Subclavian artery stenosis 2/4668 (0%) 2 1/4672 (0%) 1
Subgaleal haematoma 0/4668 (0%) 0 1/4672 (0%) 1
Thromboangiitis obliterans 0/4668 (0%) 0 1/4672 (0%) 2
Thrombophlebitis 1/4668 (0%) 1 1/4672 (0%) 1
Thrombophlebitis superficial 3/4668 (0.1%) 4 0/4672 (0%) 0
Thrombosis 1/4668 (0%) 2 0/4672 (0%) 0
Varicose vein 1/4668 (0%) 2 2/4672 (0%) 2
Vasculitis necrotising 0/4668 (0%) 0 1/4672 (0%) 1
Venous thrombosis 0/4668 (0%) 0 1/4672 (0%) 1
Other (Not Including Serious) Adverse Events
Liraglutide Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 684/4668 (14.7%) 210/4672 (4.5%)
Gastrointestinal disorders
Diarrhoea 266/4668 (5.7%) 355 102/4672 (2.2%) 124
Nausea 517/4668 (11.1%) 655 129/4672 (2.8%) 149

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.

Results Point of Contact

Name/Title Global Clinical Registry (GCR, 1452)
Organization Novo Nordisk A/S
Phone
Email clinicaltrials@novonordisk.com
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01179048
Other Study ID Numbers:
  • EX2211-3748
  • 2009-012201-19
  • U1111-1113-7090
  • CTR20130003
First Posted:
Aug 10, 2010
Last Update Posted:
Jul 17, 2019
Last Verified:
Jul 1, 2019