Safety and Efficacy of an Antibiotic Implant in Cardiac Surgical Subjects at Higher Risk for Sternal Wound Infection
Sponsor
Innocoll (Industry)
Overall Status
Completed
CT.gov ID
NCT00600483
Collaborator
Duke University (Other), Premier Research Group plc (Industry)
1,502
43
2
33
34.9
1.1
Study Details
Study Description
Brief Summary
The purpose of this study is to determine whether the gentamicin-collagen sponge is safe and effective in preventing sternal wound infections in patients undergoing cardiac surgery who are at a greater risk of developing sternal wound infections.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
Sternal wound infection (SWI) is a significant problem in cardiac surgical subjects,in particular in those with risk factors such as diabetes and obesity. There is a long unmet need for an intervention that can reduce the incidence and severity of SWIs in high-risk subjects.
Gentamicin is an antibiotic that is effective in treating certain kinds of infection. Collagen is a protein that is found in all mammals. The gentamicin-collagen sponge is a thin flat sponge made out of collagen that comes from cow tendons and containing gentamicin. When inserted into a surgical site, the collagen breaks down and the gentamicin is released at the site but very little is absorbed into the blood stream. The high levels of antibiotic at the surgical site may prevent an infection at the surgical site.
Outside of the United States more than 3,500 subjects have received treatment in clinical studies with the gentamicin-collagen sponge, primarily for orthopedic, intraabdominal, and cardiothoracic surgeries or wound infections following surgical procedures or traumatic events.
In this study, all subjects will be given treatment that is normally given to prevent surgical infections. For subjects randomly assigned to the gentamicin-collagen sponge treatment group, 2 sponges will be placed between the sternal halves during surgery. IMMEDIATELY before insertion of the sponge the surgeon should wet the sponge with saline as shown in the training/certification document. This wet sponge SHOULD BE INSERTED INTO THE STERNUM WITHIN APPROXIMATELY 15 SECONDS (AFTER THIS TIME IT MAY BECOME MORE DIFFICULT TO HANDLE). All subjects will be followed for 90 days after surgery to determine whether they develop a sternal wound infection.
Study Design
Study Type:
Interventional
Actual Enrollment
:
1502 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Randomized, Controlled, Phase 3 Study of Gentamicin-Collagen Sponge in Cardiac Surgical Subjects at Higher Risk for Sternal Wound Infection
Study Start Date
:
Dec 1, 2007
Actual Primary Completion Date
:
Sep 1, 2010
Actual Study Completion Date
:
Sep 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: gentamicin Group Insertion of 2 gentamicin-collagen sponges between the sternal halves before closure of the sternotomy |
Drug: gentamicin-collagen sponge dipped in saline
100-cm2 sponge
|
| No Intervention: Control Group Standard of care, ie, insertion of no gentamicin-collagen sponge. |
Outcome Measures
Primary Outcome Measures
- Number of Participants With Surgical Wound Infections From Surgery Through Post-operative Day 90 [90 days post cardiac surgery]
Efficacy will be evaluated by a comparison between the 2 study groups of the incidence of surgical wound infections that occur within the period from surgery through postop day 90.
Secondary Outcome Measures
- Surgically Treated Surgical Wound Infection Postoperative Day 90 [90 days post cardiac surgery]
Proportion of patients with surgically treated surgical wound infection adjudicated by an independent blinded committee.
- Proportion of Patients With Deep Surgical Wound Infections Based on Centers for Disease Control Criteria Adjudicated by an Independent Blinded Committee. [90 days post cardiac surgery]
- Proportion of Patients With Superficial Surgical Wound Infections Based on Centers for Disease Control Criteria Adjudicated by an Independent Blinded Committee. [90 days post cardiac surgery]
- Number of Participants Positive for Each Pathogen Culture [90 days post cardiac surgery]
Analysis associated with Microbial Pathogens in Adjudicated 90 Day SWI Subjects ME within Per Protocol Population. Any Microbial Pathogens Detected in SWI (ME)
- ASEPSIS Score [90 days post cardiac surgery]
ASEPSIS Score through 90 days postoperative - To compare antibiotic regimens for their effectiveness in preventing or treating wound sepsis, well-defined criteria for outcome are needed. A method of assessing wound healing has been devised that defines carefully the characteristics to be considered and how they are to be awarded points. Objective criteria are also included in the assessment. Points are given for the need for Additional treatment, the presence of Serous discharge, Erythema, Purulent exudate, and Separation of the deep tissues, the Isolation of bacteria, and the duration of inpatient Stay (ASEPSIS). The higher the points the worse outcome. Maximum Points would be 60. Minimum points would be 0
- Rehospitalization for Sternal Wound Infection [90 days post cardiac surgery]
Rehospitalization for Sternal Wound Infection - within 90 days postoperatively.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Scheduled to undergo nonemergent CABG and/or valve repair or replacement surgery through a full median sternotomy. This includes the following eligible procedures: isolated CABG surgery, isolated valve surgery, and combined CABG + valve surgery.
-
Be at higher risk for SWI, defined as the presence of diabetes mellitus (treated with either oral agent or insulin) and/or obesity, defined as BMI > 30.
-
Have the capacity to understand and sign an informed consent form.
-
Are male or female and > 18 years of age.
-
If female, be postmenopausal (no menstrual period for a minimum of 1 year), be surgically sterilized and have a negative serum or urine pregnancy test on entry in the study, or agree to use adequate birth control during the study and for 3 months after the administration of study agent. Medically acceptable contraceptives include: (1) approved hormonal contraceptives (such as birth control pills, Depo-Provera, or Lupron Depot), (2) barrier methods (such as a condom or diaphragm) used with a spermicide, or (3) an intrauterine device (IUD).
-
Agree to be available for evaluation from baseline until final evaluation at 90 days postsurgery.
Exclusion Criteria:
-
Known history of hypersensitivity to gentamicin or bovine collagen.
-
Undergoing emergency cardiac surgery (urgent surgery is allowed if informed consent is obtained and the study procedures can be performed).
-
Undergoing a significant concomitant surgical procedure (eg, carotid endarterectomy, aortic root repair or replacement, DHCA, or pulmonary resection).
-
Undergoing a minimally invasive or a thoracic surgical approach.
-
Using a preoperative mechanical assist device or IABP if inserted for shock/low output syndrome (an IABP is allowed if it is inserted for unstable angina).
-
Active and significant systemic infection, eg active endocarditis, or a history of significant recurrent systemic infection.
-
Receiving antibiotic therapy within the 2 weeks before the date of surgery.
-
Preoperative serum creatinine > 3 mg/dL or renal failure requiring dialysis.
-
History of malignancy within the past year (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence).
-
History of major organ transplantation, including bone marrow transplantation.
-
Recent history of significant drug or alcohol abuse.
-
Taking systemic immunosuppressive drugs, including steroids (at a dose > 10 mg oral prednisone daily) or a history of a current immunosuppressive condition (eg, symptomatic HIV infection), defined as a CD4 count < 200.
-
Scheduled to receive "stress doses" of glucocorticoids (ie, doses > 2 mg/kg/day of methylprednisolone or equivalent).
-
Pregnant, lactating, or of childbearing potential not practicing a birth control method with a high degree of reliability (defined in section 3.1).
-
Postsurgical life expectancy ≤ 90 days, in the investigator's or sponsor's opinion.
-
Refusal to accept medically indicated blood products.
-
Current participation or participation within 30 days before the start of this study in another experimental drug or device study, or is currently participating in a study during which the administration of investigational drugs within 90 days is anticipated.
-
Has a moderate or severe pectus deformity.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Birmingham | Alabama | United States | ||
| 2 | Florence | Alabama | United States | ||
| 3 | Pasadena | California | United States | ||
| 4 | San Francisco | California | United States | ||
| 5 | Brandon | Florida | United States | ||
| 6 | Jacksonville | Florida | United States | ||
| 7 | Miami | Florida | United States | ||
| 8 | Augusta | Georgia | United States | ||
| 9 | Maywood | Illinois | United States | ||
| 10 | Springfield | Illinois | United States | ||
| 11 | Fort Wayne | Indiana | United States | ||
| 12 | West Des Moines | Iowa | United States | ||
| 13 | Olathe | Kansas | United States | ||
| 14 | Wichita | Kansas | United States | ||
| 15 | Baltimore | Maryland | United States | ||
| 16 | Salisbury | Maryland | United States | ||
| 17 | Takoma Park | Maryland | United States | ||
| 18 | Springfield | Massachusetts | United States | ||
| 19 | Bay City | Michigan | United States | ||
| 20 | Lansing | Michigan | United States | ||
| 21 | Saginaw | Michigan | United States | ||
| 22 | Saint Louis | Missouri | United States | ||
| 23 | Omaha | Nebraska | United States | ||
| 24 | New York | New York | United States | ||
| 25 | Durham | North Carolina | United States | 27705 | |
| 26 | Durham | North Carolina | United States | ||
| 27 | Gastonia | North Carolina | United States | ||
| 28 | Greenville | North Carolina | United States | ||
| 29 | Raleigh | North Carolina | United States | ||
| 30 | Winston-Salem | North Carolina | United States | ||
| 31 | Akron | Ohio | United States | ||
| 32 | Cincinnati | Ohio | United States | ||
| 33 | Columbus | Ohio | United States | ||
| 34 | Zanesville | Ohio | United States | ||
| 35 | Portland | Oregon | United States | ||
| 36 | Allentown | Pennsylvania | United States | ||
| 37 | Bethlehem | Pennsylvania | United States | ||
| 38 | Philadelphia | Pennsylvania | United States | ||
| 39 | Dallas | Texas | United States | ||
| 40 | Houston | Texas | United States | ||
| 41 | Tomball | Texas | United States | ||
| 42 | Richmond | Virginia | United States | ||
| 43 | Tacoma | Washington | United States |
Sponsors and Collaborators
- Innocoll
- Duke University
- Premier Research Group plc
Investigators
- Study Director: David Prior, Innocoll
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Innocoll
ClinicalTrials.gov Identifier:
NCT00600483
Other Study ID Numbers:
- INN-SWI-001
First Posted:
Jan 25, 2008
Last Update Posted:
May 5, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Innocoll
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Gentamicin Group | Control Group |
|---|---|---|
| Arm/Group Description | Insertion of 2 gentamicin-collagen sponges between the sternal halves before closure of the sternotomy gentamicin-collagen sponge dipped in saline: 100-cm2 sponge | Standard of care, ie, insertion of no gentamicin-collagen sponge. |
| Period Title: Overall Study | ||
| STARTED | 753 | 749 |
| COMPLETED | 717 | 702 |
| NOT COMPLETED | 36 | 47 |
Baseline Characteristics
| Arm/Group Title | Gentamicin Group | Control Group | Total |
|---|---|---|---|
| Arm/Group Description | Insertion of 2 gentamicin-collagen sponges between the sternal halves before closure of the sternotomy gentamicin-collagen sponge dipped in saline: 100-cm2 sponge | Standard of care, ie, insertion of no gentamicin-collagen sponge. | Total of all reporting groups |
| Overall Participants | 753 | 749 | 1502 |
| Age (Years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Years] |
64.3
(9.88)
|
64.3
(10.50)
|
64.3
(10.19)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
223
29.6%
|
219
29.2%
|
442
29.4%
|
| Male |
530
70.4%
|
530
70.8%
|
1060
70.6%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
1
0.1%
|
1
0.1%
|
| Asian |
5
0.7%
|
5
0.7%
|
10
0.7%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
56
7.4%
|
59
7.9%
|
115
7.7%
|
| White |
688
91.4%
|
683
91.2%
|
1371
91.3%
|
| More than one race |
4
0.5%
|
1
0.1%
|
5
0.3%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Number of Participants With Surgical Wound Infections From Surgery Through Post-operative Day 90 |
|---|---|
| Description | Efficacy will be evaluated by a comparison between the 2 study groups of the incidence of surgical wound infections that occur within the period from surgery through postop day 90. |
| Time Frame | 90 days post cardiac surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population |
| Arm/Group Title | Gentamicin Group | Control Group |
|---|---|---|
| Arm/Group Description | Insertion of 2 gentamicin-collagen sponges between the sternal halves before closure of the sternotomy gentamicin-collagen sponge dipped in saline: 100-cm2 sponge | Standard of care, ie, insertion of no gentamicin-collagen sponge. |
| Measure Participants | 753 | 749 |
| Count of Participants [Participants] |
63
8.4%
|
65
8.7%
|
| Title | Surgically Treated Surgical Wound Infection Postoperative Day 90 |
|---|---|
| Description | Proportion of patients with surgically treated surgical wound infection adjudicated by an independent blinded committee. |
| Time Frame | 90 days post cardiac surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Population |
| Arm/Group Title | Gentamicin Group | Control Group |
|---|---|---|
| Arm/Group Description | Insertion of 2 gentamicin-collagen sponges between the sternal halves before closure of the sternotomy gentamicin-collagen sponge dipped in saline: 100-cm2 sponge | Standard of care, ie, insertion of no gentamicin-collagen sponge. |
| Measure Participants | 753 | 749 |
| Count of Participants [Participants] |
25
3.3%
|
37
4.9%
|
| Title | Proportion of Patients With Deep Surgical Wound Infections Based on Centers for Disease Control Criteria Adjudicated by an Independent Blinded Committee. |
|---|---|
| Description | |
| Time Frame | 90 days post cardiac surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Gentamicin Group | Control Group |
|---|---|---|
| Arm/Group Description | Insertion of 2 gentamicin-collagen sponges between the sternal halves before closure of the sternotomy gentamicin-collagen sponge dipped in saline: 100-cm2 sponge | Standard of care, ie, insertion of no gentamicin-collagen sponge. |
| Measure Participants | 753 | 749 |
| Count of Participants [Participants] |
14
1.9%
|
19
2.5%
|
| Title | Proportion of Patients With Superficial Surgical Wound Infections Based on Centers for Disease Control Criteria Adjudicated by an Independent Blinded Committee. |
|---|---|
| Description | |
| Time Frame | 90 days post cardiac surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Gentamicin Group | Control Group |
|---|---|---|
| Arm/Group Description | Insertion of 2 gentamicin-collagen sponges between the sternal halves before closure of the sternotomy gentamicin-collagen sponge dipped in saline: 100-cm2 sponge | Standard of care, ie, insertion of no gentamicin-collagen sponge. |
| Measure Participants | 753 | 749 |
| Count of Participants [Participants] |
49
6.5%
|
46
6.1%
|
| Title | Number of Participants Positive for Each Pathogen Culture |
|---|---|
| Description | Analysis associated with Microbial Pathogens in Adjudicated 90 Day SWI Subjects ME within Per Protocol Population. Any Microbial Pathogens Detected in SWI (ME) |
| Time Frame | 90 days post cardiac surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| PP Population: INN-SWI-001) |
| Arm/Group Title | Gentamicin Group | Control Group |
|---|---|---|
| Arm/Group Description | Insertion of 2 gentamicin-collagen sponges between the sternal halves before closure of the sternotomy gentamicin-collagen sponge dipped in saline: 100-cm2 sponge | Standard of care, ie, insertion of no gentamicin-collagen sponge. |
| Measure Participants | 27 | 32 |
| Acinetobacter calcoaceticus |
1
0.1%
|
0
0%
|
| Coagulase-neg staphylococci |
0
0%
|
2
0.3%
|
| Enterobacter cloacae |
2
0.3%
|
1
0.1%
|
| Enterococcus faecalis |
1
0.1%
|
1
0.1%
|
| Escherichia coli |
3
0.4%
|
3
0.4%
|
| Group B species streptococcus |
1
0.1%
|
0
0%
|
| Klebsiella pneumoniae |
0
0%
|
2
0.3%
|
| Klebsiella spp |
1
0.1%
|
2
0.3%
|
| Methicillin-resistant SA |
2
0.3%
|
1
0.1%
|
| Methicillin-sensitive SA |
6
0.8%
|
2
0.3%
|
| Other Specify 1 |
3
0.4%
|
3
0.4%
|
| Proteus mirabilis |
4
0.5%
|
5
0.7%
|
| Providencia stuartii |
1
0.1%
|
0
0%
|
| Pseudomonas aeruginosa |
3
0.4%
|
3
0.4%
|
| Serratia marcescens |
2
0.3%
|
4
0.5%
|
| Staphylococcus aureus |
5
0.7%
|
6
0.8%
|
| Staphylococcus capitis |
1
0.1%
|
0
0%
|
| Staphylococcus epidermidis |
2
0.3%
|
7
0.9%
|
| Staphylococcus hominis |
0
0%
|
1
0.1%
|
| Staphylococcus lugdunensis |
0
0%
|
1
0.1%
|
| Staphylococcus xylosus |
0
0%
|
1
0.1%
|
| Streptococcus agalactiae |
1
0.1%
|
0
0%
|
| Title | ASEPSIS Score |
|---|---|
| Description | ASEPSIS Score through 90 days postoperative - To compare antibiotic regimens for their effectiveness in preventing or treating wound sepsis, well-defined criteria for outcome are needed. A method of assessing wound healing has been devised that defines carefully the characteristics to be considered and how they are to be awarded points. Objective criteria are also included in the assessment. Points are given for the need for Additional treatment, the presence of Serous discharge, Erythema, Purulent exudate, and Separation of the deep tissues, the Isolation of bacteria, and the duration of inpatient Stay (ASEPSIS). The higher the points the worse outcome. Maximum Points would be 60. Minimum points would be 0 |
| Time Frame | 90 days post cardiac surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population |
| Arm/Group Title | Gentamicin Group | Control Group |
|---|---|---|
| Arm/Group Description | Insertion of 2 gentamicin-collagen sponges between the sternal halves before closure of the sternotomy gentamicin-collagen sponge dipped in saline: 100-cm2 sponge | Standard of care, ie, insertion of no gentamicin-collagen sponge. |
| Measure Participants | 753 | 749 |
| Mean (Standard Deviation) [score on a scale] |
1.9
(6.32)
|
2.0
(7.18)
|
| Title | Rehospitalization for Sternal Wound Infection |
|---|---|
| Description | Rehospitalization for Sternal Wound Infection - within 90 days postoperatively. |
| Time Frame | 90 days post cardiac surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Gentamicin Group | Control Group |
|---|---|---|
| Arm/Group Description | Insertion of 2 gentamicin-collagen sponges between the sternal halves before closure of the sternotomy gentamicin-collagen sponge dipped in saline: 100-cm2 sponge | Standard of care, ie, insertion of no gentamicin-collagen sponge. |
| Measure Participants | 753 | 749 |
| Count of Participants [Participants] |
23
3.1%
|
24
3.2%
|
Adverse Events
| Time Frame | 90 days from Randomization. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | 10 Subject were randomized but not treated at the sites by error (mis randomized). Therefore the safety population has 10 less participants receiving Gentamicin and 10 additional in the Control | |||
| Arm/Group Title | Gentamicin Group | Control Group | ||
| Arm/Group Description | Insertion of 2 gentamicin-collagen sponges between the sternal halves before closure of the sternotomy gentamicin-collagen sponge dipped in saline: 100-cm2 sponge | Standard of care, ie, insertion of no gentamicin-collagen sponge. Includes patients randomized to Gentamicin but where not treated in the Gentamicin group | ||
All Cause Mortality |
||||
| Gentamicin Group | Control Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 19/743 (2.6%) | 27/759 (3.6%) | ||
Serious Adverse Events |
||||
| Gentamicin Group | Control Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 269/743 (36.2%) | 290/759 (38.2%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 2/743 (0.3%) | 2 | 2/759 (0.3%) | 2 |
| Coagulopathy | 5/743 (0.7%) | 5 | 4/759 (0.5%) | 4 |
| Heparin-induced thrombocytopenia | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Lymphadenopathy mediastinal | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Thrombocytopenia | 1/743 (0.1%) | 1 | 1/759 (0.1%) | 1 |
| Cardiac disorders | ||||
| Acute coronary syndrome | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Acute myocardial infarction | 4/743 (0.5%) | 4 | 6/759 (0.8%) | 6 |
| Angina pectoris | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Angina unstable | 2/743 (0.3%) | 2 | 1/759 (0.1%) | 1 |
| Arrhythmia | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Atrial fibrillation | 19/743 (2.6%) | 19 | 23/759 (3%) | 23 |
| Atrial flutter | 12/743 (1.6%) | 12 | 5/759 (0.7%) | 5 |
| Atrial tachycardia | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Atrioventricular block | 2/743 (0.3%) | 2 | 2/759 (0.3%) | 2 |
| Atrioventricular block complete | 2/743 (0.3%) | 2 | 4/759 (0.5%) | 4 |
| Bradycardia | 10/743 (1.3%) | 10 | 5/759 (0.7%) | 5 |
| Cardiac arrest | 6/743 (0.8%) | 6 | 6/759 (0.8%) | 6 |
| Cardiac failure | 1/743 (0.1%) | 1 | 1/759 (0.1%) | 1 |
| Cardiac failure congestive | 28/743 (3.8%) | 28 | 29/759 (3.8%) | 29 |
| Cardiac tamponade | 3/743 (0.4%) | 3 | 5/759 (0.7%) | 5 |
| Cardio-respiratory arrest | 1/743 (0.1%) | 1 | 1/759 (0.1%) | 1 |
| Cardiogenic shock | 1/743 (0.1%) | 1 | 3/759 (0.4%) | 3 |
| Coronary artery disease | 0/743 (0%) | 0 | 2/759 (0.3%) | 2 |
| Dressler's syndrome | 1/743 (0.1%) | 1 | 2/759 (0.3%) | 2 |
| Intracardiac thrombus | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Ischaemic cardiomyopathy | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Low cardiac output syndrome | 0/743 (0%) | 0 | 2/759 (0.3%) | 2 |
| Myocardial infarction | 1/743 (0.1%) | 1 | 4/759 (0.5%) | 4 |
| Nodal rhythm | 2/743 (0.3%) | 2 | 0/759 (0%) | 0 |
| Pericardial effusion | 5/743 (0.7%) | 5 | 7/759 (0.9%) | 7 |
| Pericarditis | 1/743 (0.1%) | 1 | 1/759 (0.1%) | 1 |
| Sick sinus syndrome | 5/743 (0.7%) | 5 | 8/759 (1.1%) | 8 |
| Sinus arrest | 1/743 (0.1%) | 1 | 1/759 (0.1%) | 1 |
| Stress cardiomyopathy | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Supraventricular tachycardia | 1/743 (0.1%) | 1 | 1/759 (0.1%) | 1 |
| Tachycardia | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Ventricular dysfunction | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Ventricular failure | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Ventricular fibrillation | 1/743 (0.1%) | 1 | 5/759 (0.7%) | 5 |
| Ventricular tachycardia | 2/743 (0.3%) | 2 | 3/759 (0.4%) | 3 |
| Congenital, familial and genetic disorders | ||||
| Atrial septal defect | 1/743 (0.1%) | 1 | 1/759 (0.1%) | 1 |
| Gastrointestinal arteriovenous malformation | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Abdominal pain | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Abdominal pain upper | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Colitis | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Constipation | 3/743 (0.4%) | 3 | 1/759 (0.1%) | 1 |
| Diabetic gastroparesis | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Diarrhoea | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Duodenal ulcer haemorrhage | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Dysphagia | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Erosive oesophagitis | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Gastrointestinal haemorrhage | 1/743 (0.1%) | 1 | 5/759 (0.7%) | 5 |
| Gastrointestinal ischaemia | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Haematochezia | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Ileus | 0/743 (0%) | 0 | 4/759 (0.5%) | 4 |
| Inguinal hernia, obstructive | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Intestinal ischaemia | 1/743 (0.1%) | 1 | 3/759 (0.4%) | 3 |
| Nausea | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Oesophageal ulcer | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Oesophageal ulcer haemorrhage | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Pancreatitis | 4/743 (0.5%) | 4 | 1/759 (0.1%) | 1 |
| Pancreatitis acute | 1/743 (0.1%) | 1 | 1/759 (0.1%) | 1 |
| Peptic ulcer haemorrhage | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Small intestinal obstruction | 1/743 (0.1%) | 1 | 1/759 (0.1%) | 1 |
| Volvulus | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Vomiting | 1/743 (0.1%) | 1 | 2/759 (0.3%) | 2 |
| General disorders | ||||
| Asthenia | 2/743 (0.3%) | 2 | 3/759 (0.4%) | 3 |
| Catheter site haemorrhage | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Generalised oedema | 1/743 (0.1%) | 1 | 1/759 (0.1%) | 1 |
| Impaired healing | 1/743 (0.1%) | 1 | 1/759 (0.1%) | 1 |
| Malaise | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Mechanical complication of implant | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Multi-organ failure | 4/743 (0.5%) | 4 | 5/759 (0.7%) | 5 |
| Non-cardiac chest pain | 9/743 (1.2%) | 9 | 7/759 (0.9%) | 7 |
| Pyrexia | 2/743 (0.3%) | 2 | 0/759 (0%) | 0 |
| Hepatobiliary disorders | ||||
| Systemic inflammatory response syndrome | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Cholecystitis | 3/743 (0.4%) | 3 | 2/759 (0.3%) | 2 |
| Cholecystitis acute | 0/743 (0%) | 0 | 2/759 (0.3%) | 2 |
| Cholelithiasis | 1/743 (0.1%) | 1 | 3/759 (0.4%) | 3 |
| Infections and infestations | ||||
| Bacteraemia | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Bronchitis | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Cellulitis | 9/743 (1.2%) | 9 | 4/759 (0.5%) | 4 |
| Cholecystitis infective | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Clostridium difficile colitis | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Diabetic foot infection | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Enterococcal infection | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Gangrene | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Gastroenteritis | 1/743 (0.1%) | 1 | 1/759 (0.1%) | 1 |
| Gastroenteritis viral | 1/743 (0.1%) | 1 | 1/759 (0.1%) | 1 |
| Incision site cellulitis | 2/743 (0.3%) | 2 | 0/759 (0%) | 0 |
| Incision site infection | 1/743 (0.1%) | 1 | 1/759 (0.1%) | 1 |
| Lobar pneumonia | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Lung infection pseudomonal | 0/743 (0%) | 0 | 2/759 (0.3%) | 2 |
| Mediastinitis | 1/743 (0.1%) | 1 | 2/759 (0.3%) | 2 |
| Osteomyelitis | 0/743 (0%) | 0 | 3/759 (0.4%) | 3 |
| Pneumonia | 5/743 (0.7%) | 5 | 20/759 (2.6%) | 20 |
| Pneumonia bacterial | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Pneumonia escherichia | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Pneumonia klebsiella | 1/743 (0.1%) | 1 | 1/759 (0.1%) | 1 |
| Postoperative abscess | 1/743 (0.1%) | 1 | 1/759 (0.1%) | 1 |
| Postoperative wound infection | 17/743 (2.3%) | 17 | 24/759 (3.2%) | 24 |
| Pyelonephritis | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Sepsis | 5/743 (0.7%) | 5 | 8/759 (1.1%) | 8 |
| Septic shock | 1/743 (0.1%) | 1 | 1/759 (0.1%) | 1 |
| Small intestine gangrene | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Staphylococcal abscess | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Staphylococcal bacteraemia | 1/743 (0.1%) | 1 | 1/759 (0.1%) | 1 |
| Staphylococcal infection | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Staphylococcal mediastinitis | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Staphylococcal sepsis | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Tracheobronchitis | 1/743 (0.1%) | 1 | 2/759 (0.3%) | 2 |
| Urinary tract infection | 2/743 (0.3%) | 2 | 3/759 (0.4%) | 3 |
| Wound infection | 1/743 (0.1%) | 1 | 2/759 (0.3%) | 2 |
| Wound infection staphylococcal | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Anaemia postoperative | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Cardiac pacemaker malfunction | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Cardiac procedure complication | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Complication of device removal | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Concussion | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Confusion postoperative | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Contusion | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Delayed recovery from anaesthesia | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Device breakage | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Device leakage | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Excoriation | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Fall | 1/743 (0.1%) | 1 | 1/759 (0.1%) | 1 |
| Graft thrombosis | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Incision site haematoma | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Incision site pain | 0/743 (0%) | 0 | 2/759 (0.3%) | 2 |
| Operative haemorrhage | 0/743 (0%) | 0 | 2/759 (0.3%) | 2 |
| Post procedural bile leak | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Post procedural discharge | 4/743 (0.5%) | 4 | 0/759 (0%) | 0 |
| Post procedural haematoma | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Post procedural haemorrhage | 9/743 (1.2%) | 9 | 10/759 (1.3%) | 10 |
| Post procedural myocardial infarction | 1/743 (0.1%) | 1 | 2/759 (0.3%) | 2 |
| Postoperative ileus | 1/743 (0.1%) | 1 | 2/759 (0.3%) | 2 |
| Postoperative renal failure | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Postoperative thoracic procedure complication | 5/743 (0.7%) | 5 | 2/759 (0.3%) | 2 |
| Postoperative wound complication | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Procedural hypotension | 1/743 (0.1%) | 1 | 1/759 (0.1%) | 1 |
| Procedural pain | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Therapeutic agent toxicity | 2/743 (0.3%) | 2 | 1/759 (0.1%) | 1 |
| Vascular graft complication | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Vascular graft occlusion | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Vascular pseudoaneurysm | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Weaning failure | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Wound dehiscence | 2/743 (0.3%) | 2 | 5/759 (0.7%) | 5 |
| Investigations | ||||
| Anticoagulation drug level below therapeutic | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Blood glucose fluctuation | 1/743 (0.1%) | 1 | 1/759 (0.1%) | 1 |
| Blood pressure decreased | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Clostridium difficile toxin test positive | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| International normalised ratio increased | 1/743 (0.1%) | 1 | 1/759 (0.1%) | 1 |
| Platelet count decreased | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Troponin increased | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Metabolism and nutrition disorders | ||||
| Dehydration | 2/743 (0.3%) | 2 | 3/759 (0.4%) | 3 |
| Diabetes mellitus inadequate control | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Diabetic ketoacidosis | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Fluid overload | 4/743 (0.5%) | 4 | 2/759 (0.3%) | 2 |
| Hyperkalaemia | 3/743 (0.4%) | 3 | 0/759 (0%) | 0 |
| Hypocalcaemia | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Hypoglycaemia | 1/743 (0.1%) | 1 | 2/759 (0.3%) | 2 |
| Hypokalaemia | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Hyponatraemia | 1/743 (0.1%) | 1 | 1/759 (0.1%) | 1 |
| Hypovolaemia | 2/743 (0.3%) | 2 | 0/759 (0%) | 0 |
| Lactic acidosis | 1/743 (0.1%) | 1 | 1/759 (0.1%) | 1 |
| Metabolic acidosis | 1/743 (0.1%) | 1 | 1/759 (0.1%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| Intervertebral disc protrusion | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Muscle haemorrhage | 0/743 (0%) | 0 | 2/759 (0.3%) | 2 |
| Musculoskeletal pain | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Pain in extremity | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Rhabdomyolysis | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Bladder transitional cell carcinoma | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Colon cancer | 1/743 (0.1%) | 1 | 1/759 (0.1%) | 1 |
| Myelodysplastic syndrome | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Pancreatic carcinoma | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Small cell lung cancer metastatic | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Nervous system disorders | ||||
| Aphasia | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Carotid artery stenosis | 1/743 (0.1%) | 1 | 1/759 (0.1%) | 1 |
| Cerebral infarction | 2/743 (0.3%) | 2 | 3/759 (0.4%) | 3 |
| Cerebrovascular accident | 7/743 (0.9%) | 7 | 8/759 (1.1%) | 8 |
| Cognitive disorder | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Convulsion | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Depressed level of consciousness | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Dizziness | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Dysarthria | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Embolic stroke | 1/743 (0.1%) | 1 | 1/759 (0.1%) | 1 |
| Encephalopathy | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Facial paresis | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Hepatic encephalopathy | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Ischaemic cerebral infarction | 0/743 (0%) | 0 | 2/759 (0.3%) | 2 |
| Ischaemic stroke | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Metabolic encephalopathy | 3/743 (0.4%) | 3 | 2/759 (0.3%) | 2 |
| Paraesthesia | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Presyncope | 1/743 (0.1%) | 1 | 2/759 (0.3%) | 2 |
| Somnolence | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Syncope | 1/743 (0.1%) | 1 | 2/759 (0.3%) | 2 |
| Transient ischaemic attack | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Unresponsive to stimuli | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Psychiatric disorders | ||||
| Agitation | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Anxiety | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Confusional state | 1/743 (0.1%) | 1 | 1/759 (0.1%) | 1 |
| Depression | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Disorientation | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Major depression | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Mental status changes | 1/743 (0.1%) | 1 | 1/759 (0.1%) | 1 |
| Psychotic disorder | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Renal and urinary disorders | ||||
| Azotaemia | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Dysuria | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Nephropathy toxic | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Renal failure | 3/743 (0.4%) | 3 | 6/759 (0.8%) | 6 |
| Renal failure acute | 18/743 (2.4%) | 18 | 23/759 (3%) | 23 |
| Renal failure chronic | 0/743 (0%) | 0 | 2/759 (0.3%) | 2 |
| Renal tubular necrosis | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Urinary retention | 2/743 (0.3%) | 2 | 0/759 (0%) | 0 |
| Reproductive system and breast disorders | ||||
| Prostatitis | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Acute pulmonary oedema | 1/743 (0.1%) | 1 | 1/759 (0.1%) | 1 |
| Acute respiratory distress syndrome | 0/743 (0%) | 0 | 3/759 (0.4%) | 3 |
| Acute respiratory failure | 12/743 (1.6%) | 12 | 10/759 (1.3%) | 10 |
| Atelectasis | 2/743 (0.3%) | 2 | 1/759 (0.1%) | 1 |
| Chronic obstructive pulmonary disease | 4/743 (0.5%) | 4 | 3/759 (0.4%) | 3 |
| Dyspnoea | 2/743 (0.3%) | 2 | 1/759 (0.1%) | 1 |
| Dyspnoea exertional | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Haemoptysis | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Haemothorax | 2/743 (0.3%) | 2 | 2/759 (0.3%) | 2 |
| Hypoxia | 4/743 (0.5%) | 4 | 4/759 (0.5%) | 4 |
| Laryngeal keratotic plaque | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Lung hernia | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Mediastinal haematoma | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Mediastinal haemorrhage | 4/743 (0.5%) | 4 | 8/759 (1.1%) | 8 |
| Mediastinal mass | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Orthopnoea | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Pleural effusion | 28/743 (3.8%) | 28 | 25/759 (3.3%) | 25 |
| Pleurisy | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Pleuritic pain | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Pneumonia aspiration | 2/743 (0.3%) | 2 | 1/759 (0.1%) | 1 |
| Pneumonitis | 0/743 (0%) | 0 | 2/759 (0.3%) | 2 |
| Pneumothorax | 3/743 (0.4%) | 3 | 2/759 (0.3%) | 2 |
| Pulmonary congestion | 0/743 (0%) | 0 | 9/759 (1.2%) | 9 |
| Pulmonary embolism | 4/743 (0.5%) | 4 | 2/759 (0.3%) | 2 |
| Pulmonary hypertension | 1/743 (0.1%) | 1 | 4/759 (0.5%) | 4 |
| Pulmonary oedema | 5/743 (0.7%) | 5 | 0/759 (0%) | 0 |
| Respiratory acidosis | 1/743 (0.1%) | 1 | 5/759 (0.7%) | 5 |
| Respiratory arrest | 0/743 (0%) | 0 | 9/759 (1.2%) | 9 |
| Respiratory distress | 6/743 (0.8%) | 6 | 25/759 (3.3%) | 25 |
| Respiratory failure | 23/743 (3.1%) | 23 | 21/759 (2.8%) | 21 |
| Vascular disorders | ||||
| Aortic dissection | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Aortic rupture | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Aortic stenosis | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Arterial haemorrhage | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Arterial thrombosis limb | 1/743 (0.1%) | 1 | 1/759 (0.1%) | 1 |
| Deep vein thrombosis | 5/743 (0.7%) | 5 | 4/759 (0.5%) | 4 |
| Femoral artery occlusion | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Haematoma | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Hypertension | 2/743 (0.3%) | 2 | 1/759 (0.1%) | 1 |
| Hypertensive crisis | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Hypotension | 8/743 (1.1%) | 8 | 10/759 (1.3%) | 10 |
| Hypovolaemic shock | 0/743 (0%) | 0 | 1/759 (0.1%) | 1 |
| Labile blood pressure | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Orthostatic hypotension | 1/743 (0.1%) | 1 | 1/759 (0.1%) | 1 |
| Peripheral vascular disorder | 2/743 (0.3%) | 2 | 0/759 (0%) | 0 |
| Phlebitis superficial | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
| Shock | 1/743 (0.1%) | 1 | 0/759 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| Gentamicin Group | Control Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 741/743 (99.7%) | 757/759 (99.7%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 320/743 (43.1%) | 326/759 (43%) | ||
| Blood disorder | 0/743 (0%) | 1/759 (0.1%) | ||
| Coagulopathy | 4/743 (0.5%) | 1/759 (0.1%) | ||
| Haemoconcentration | 1/743 (0.1%) | 0/759 (0%) | ||
| Haemorrhagic anaemia | 40/743 (5.4%) | 51/759 (6.7%) | ||
| Heparin-induced thrombocytopenia | 1/743 (0.1%) | 3/759 (0.4%) | ||
| Hypercoagulation | 1/743 (0.1%) | 0/759 (0%) | ||
| Iron deficiency anaemia | 1/743 (0.1%) | 2/759 (0.3%) | ||
| Leukocytosis | 164/743 (22.1%) | 154/759 (20.3%) | ||
| Leukopenia | 4/743 (0.5%) | 2/759 (0.3%) | ||
| Lymphadenopathy | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Lymphadenopathy mediastinal | 1/743 (0.1%) | 0/759 (0%) | ||
| Lymphopenia | 0/743 (0%) | 1/759 (0.1%) | ||
| Neutropenia | 7/743 (0.9%) | 1/759 (0.1%) | ||
| Neutrophilia | 2/743 (0.3%) | 1/759 (0.1%) | ||
| Splenomegaly | 1/743 (0.1%) | 0/759 (0%) | ||
| Thrombocythaemia | 3/743 (0.4%) | 3/759 (0.4%) | ||
| Thrombocytopenia | 150/743 (20.2%) | 161/759 (21.2%) | ||
| Cardiac disorders | ||||
| Acute left ventricular failure | 0/743 (0%) | 1/759 (0.1%) | ||
| Acute myocardial infarction | 2/743 (0.3%) | 1/759 (0.1%) | ||
| Angina pectoris | 4/743 (0.5%) | 5/759 (0.7%) | ||
| Aortic valve incompetence | 0/743 (0%) | 1/759 (0.1%) | ||
| Aortic valve sclerosis | 0/743 (0%) | 1/759 (0.1%) | ||
| Arrhythmia | 5/743 (0.7%) | 11/759 (1.4%) | ||
| Arrhythmia supraventricular | 4/743 (0.5%) | 1/759 (0.1%) | ||
| Atrial fibrillation | 186/743 (25%) | 192/759 (25.3%) | ||
| Atrial flutter | 12/743 (1.6%) | 24/759 (3.2%) | ||
| Atrial hypertrophy | 0/743 (0%) | 1/759 (0.1%) | ||
| Atrial tachycardia | 1/743 (0.1%) | 0/759 (0%) | ||
| Atrioventricular block | 4/743 (0.5%) | 5/759 (0.7%) | ||
| Atrioventricular block complete | 2/743 (0.3%) | 4/759 (0.5%) | ||
| Atrioventricular block first degree | 7/743 (0.9%) | 12/759 (1.6%) | ||
| Atrioventricular block second degree | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Bifascicular block | 1/743 (0.1%) | 0/759 (0%) | ||
| Bradyarrhythmia | 0/743 (0%) | 1/759 (0.1%) | ||
| Bradycardia | 22/743 (3%) | 30/759 (4%) | ||
| Bundle branch block | 3/743 (0.4%) | 3/759 (0.4%) | ||
| Bundle branch block left | 2/743 (0.3%) | 2/759 (0.3%) | ||
| Bundle branch block right | 3/743 (0.4%) | 4/759 (0.5%) | ||
| Cardiac arrest | 2/743 (0.3%) | 1/759 (0.1%) | ||
| Cardiac failure | 0/743 (0%) | 2/759 (0.3%) | ||
| Cardiac failure congestive | 36/743 (4.8%) | 39/759 (5.1%) | ||
| Cardiogenic shock | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Cardiomegaly | 80/743 (10.8%) | 62/759 (8.2%) | ||
| Cyanosis | 1/743 (0.1%) | 2/759 (0.3%) | ||
| Dilatation atrial | 1/743 (0.1%) | 0/759 (0%) | ||
| Dressler's syndrome | 0/743 (0%) | 1/759 (0.1%) | ||
| Extrasystoles | 5/743 (0.7%) | 5/759 (0.7%) | ||
| Intracardiac thrombus | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Ischaemic cardiomyopathy | 1/743 (0.1%) | 0/759 (0%) | ||
| Left atrial dilatation | 0/743 (0%) | 1/759 (0.1%) | ||
| Left ventricular dysfunction | 3/743 (0.4%) | 1/759 (0.1%) | ||
| Left ventricular hypertrophy | 2/743 (0.3%) | 0/759 (0%) | ||
| Mitral valve calcification | 1/743 (0.1%) | 0/759 (0%) | ||
| Mitral valve incompetence | 2/743 (0.3%) | 1/759 (0.1%) | ||
| Myocardial infarction | 1/743 (0.1%) | 2/759 (0.3%) | ||
| Myocardial ischaemia | 1/743 (0.1%) | 0/759 (0%) | ||
| Nodal arrhythmia | 3/743 (0.4%) | 2/759 (0.3%) | ||
| Nodal rhythm | 9/743 (1.2%) | 15/759 (2%) | ||
| Palpitations | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Pericardial effusion | 15/743 (2%) | 9/759 (1.2%) | ||
| Pericardial rub | 36/743 (4.8%) | 32/759 (4.2%) | ||
| Pericarditis | 6/743 (0.8%) | 7/759 (0.9%) | ||
| Pulmonary valve incompetence | 0/743 (0%) | 1/759 (0.1%) | ||
| Right atrial dilatation | 0/743 (0%) | 1/759 (0.1%) | ||
| Sick sinus syndrome | 1/743 (0.1%) | 0/759 (0%) | ||
| Sinus arrest | 0/743 (0%) | 2/759 (0.3%) | ||
| Sinus arrhythmia | 2/743 (0.3%) | 1/759 (0.1%) | ||
| Sinus bradycardia | 18/743 (2.4%) | 15/759 (2%) | ||
| Sinus tachycardia | 70/743 (9.4%) | 60/759 (7.9%) | ||
| Supraventricular extrasystoles | 15/743 (2%) | 12/759 (1.6%) | ||
| Supraventricular tachycardia | 10/743 (1.3%) | 16/759 (2.1%) | ||
| Tachycardia | 33/743 (4.4%) | 24/759 (3.2%) | ||
| Tachycardia paroxysmal | 9/743 (1.2%) | 11/759 (1.4%) | ||
| Tricuspid valve incompetence | 0/743 (0%) | 1/759 (0.1%) | ||
| Tricuspid valve prolapse | 0/743 (0%) | 1/759 (0.1%) | ||
| Ventricular arrhythmia | 3/743 (0.4%) | 1/759 (0.1%) | ||
| Ventricular dysfunction | 0/743 (0%) | 1/759 (0.1%) | ||
| Ventricular extrasystoles | 39/743 (5.2%) | 30/759 (4%) | ||
| Ventricular fibrillation | 0/743 (0%) | 1/759 (0.1%) | ||
| Ventricular hypokinesia | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Ventricular tachycardia | 28/743 (3.8%) | 29/759 (3.8%) | ||
| Wolff-parkinson-white syndrome | 0/743 (0%) | 1/759 (0.1%) | ||
| Congenital, familial and genetic disorders | ||||
| Atrial septal defect | 0/743 (0%) | 1/759 (0.1%) | ||
| Ear and labyrinth disorders | ||||
| Deafness | 2/743 (0.3%) | 1/759 (0.1%) | ||
| Hypoacusis | 1/743 (0.1%) | 0/759 (0%) | ||
| Vertigo | 7/743 (0.9%) | 3/759 (0.4%) | ||
| Vertigo positional | 1/743 (0.1%) | 0/759 (0%) | ||
| Endocrine disorders | 3/743 (0.4%) | 0/759 (0%) | ||
| Adrenal mass | 1/743 (0.1%) | 0/759 (0%) | ||
| Hypothyroidism | 2/743 (0.3%) | 0/759 (0%) | ||
| Eye disorders | 19/743 (2.6%) | 9/759 (1.2%) | ||
| Diplopia | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Dry eye | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Eye haemorrhage | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Eye pruritus | 1/743 (0.1%) | 0/759 (0%) | ||
| Eye swelling | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Lacrimation increased | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Myodesopsia | 1/743 (0.1%) | 0/759 (0%) | ||
| Ocular hyperaemia | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Pupils unequal | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Retinal artery embolism | 1/743 (0.1%) | 0/759 (0%) | ||
| Vision blurred | 5/743 (0.7%) | 1/759 (0.1%) | ||
| Visual acuity reduced | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Visual impairment | 2/743 (0.3%) | 0/759 (0%) | ||
| Gastrointestinal disorders | ||||
| Abdominal discomfort | 9/743 (1.2%) | 5/759 (0.7%) | ||
| Abdominal distension | 11/743 (1.5%) | 20/759 (2.6%) | ||
| Abdominal pain | 10/743 (1.3%) | 5/759 (0.7%) | ||
| Abdominal pain lower | 2/743 (0.3%) | 2/759 (0.3%) | ||
| Abdominal pain upper | 3/743 (0.4%) | 2/759 (0.3%) | ||
| Abdominal tenderness | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Ascites | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Barrett's oesophagus | 1/743 (0.1%) | 0/759 (0%) | ||
| Chapped lips | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Colitis ischaemic | 0/743 (0%) | 1/759 (0.1%) | ||
| Constipation | 134/743 (18%) | 138/759 (18.2%) | ||
| Diarrhoea | 33/743 (4.4%) | 27/759 (3.6%) | ||
| Dry mouth | 1/743 (0.1%) | 3/759 (0.4%) | ||
| Duodenal ulcer | 1/743 (0.1%) | 0/759 (0%) | ||
| Dyspepsia | 10/743 (1.3%) | 11/759 (1.4%) | ||
| Dysphagia | 8/743 (1.1%) | 3/759 (0.4%) | ||
| Faecal incontinence | 2/743 (0.3%) | 4/759 (0.5%) | ||
| Faecaloma | 2/743 (0.3%) | 0/759 (0%) | ||
| Flatulence | 4/743 (0.5%) | 4/759 (0.5%) | ||
| Gastric disorder | 1/743 (0.1%) | 0/759 (0%) | ||
| Gastritis | 1/743 (0.1%) | 0/759 (0%) | ||
| Gastritis erosive | 0/743 (0%) | 1/759 (0.1%) | ||
| Gastritis haemorrhagic | 0/743 (0%) | 1/759 (0.1%) | ||
| Gastrointestinal haemorrhage | 2/743 (0.3%) | 1/759 (0.1%) | ||
| Gastrointestinal sounds abnormal | 11/743 (1.5%) | 8/759 (1.1%) | ||
| Gastrooesophageal reflux disease | 2/743 (0.3%) | 1/759 (0.1%) | ||
| Gingival bleeding | 1/743 (0.1%) | 0/759 (0%) | ||
| Haematemesis | 2/743 (0.3%) | 0/759 (0%) | ||
| Haematochezia | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Haemorrhoidal haemorrhage | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Haemorrhoids | 2/743 (0.3%) | 1/759 (0.1%) | ||
| Ileus | 6/743 (0.8%) | 5/759 (0.7%) | ||
| Impaired gastric emptying | 3/743 (0.4%) | 2/759 (0.3%) | ||
| Intestinal dilatation | 1/743 (0.1%) | 0/759 (0%) | ||
| Lip swelling | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Melaena | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Nausea | 254/743 (34.2%) | 255/759 (33.6%) | ||
| Odynophagia | 1/743 (0.1%) | 0/759 (0%) | ||
| Oesophageal ulcer | 1/743 (0.1%) | 0/759 (0%) | ||
| Oral disorder | 1/743 (0.1%) | 0/759 (0%) | ||
| Pancreatitis | 2/743 (0.3%) | 1/759 (0.1%) | ||
| Peptic ulcer | 1/743 (0.1%) | 0/759 (0%) | ||
| Peritoneal haematoma | 0/743 (0%) | 1/759 (0.1%) | ||
| Proctalgia | 1/743 (0.1%) | 0/759 (0%) | ||
| Rectal haemorrhage | 0/743 (0%) | 3/759 (0.4%) | ||
| Reflux oesophagitis | 0/743 (0%) | 1/759 (0.1%) | ||
| Retching | 0/743 (0%) | 1/759 (0.1%) | ||
| Retroperitoneal haematoma | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Salivary gland cyst | 1/743 (0.1%) | 0/759 (0%) | ||
| Salivary hypersecretion | 3/743 (0.4%) | 0/759 (0%) | ||
| Small intestinal obstruction | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Stomatitis | 2/743 (0.3%) | 0/759 (0%) | ||
| Swollen tongue | 1/743 (0.1%) | 2/759 (0.3%) | ||
| Tongue oedema | 1/743 (0.1%) | 0/759 (0%) | ||
| Toothache | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Umbilical hernia, obstructive | 0/743 (0%) | 1/759 (0.1%) | ||
| Upper gastrointestinal haemorrhage | 0/743 (0%) | 2/759 (0.3%) | ||
| Vomiting | 52/743 (7%) | 55/759 (7.2%) | ||
| General disorders | ||||
| Adverse drug reaction | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Asthenia | 49/743 (6.6%) | 43/759 (5.7%) | ||
| Axillary pain | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Breakthrough pain | 0/743 (0%) | 2/759 (0.3%) | ||
| Catheter site discharge | 1/743 (0.1%) | 2/759 (0.3%) | ||
| Catheter site haematoma | 2/743 (0.3%) | 3/759 (0.4%) | ||
| Catheter site haemorrhage | 3/743 (0.4%) | 5/759 (0.7%) | ||
| Catheter site pain | 3/743 (0.4%) | 2/759 (0.3%) | ||
| Catheter site related reaction | 0/743 (0%) | 1/759 (0.1%) | ||
| Catheter thrombosis | 0/743 (0%) | 1/759 (0.1%) | ||
| Chest discomfort | 3/743 (0.4%) | 2/759 (0.3%) | ||
| Chest pain | 6/743 (0.8%) | 2/759 (0.3%) | ||
| Chills | 11/743 (1.5%) | 8/759 (1.1%) | ||
| Discomfort | 4/743 (0.5%) | 0/759 (0%) | ||
| Face oedema | 0/743 (0%) | 1/759 (0.1%) | ||
| Fatigue | 15/743 (2%) | 10/759 (1.3%) | ||
| Feeling cold | 1/743 (0.1%) | 0/759 (0%) | ||
| Feeling hot | 1/743 (0.1%) | 2/759 (0.3%) | ||
| Gait disturbance | 4/743 (0.5%) | 3/759 (0.4%) | ||
| General symptom | 0/743 (0%) | 1/759 (0.1%) | ||
| Generalised oedema | 208/743 (28%) | 224/759 (29.5%) | ||
| Granuloma | 1/743 (0.1%) | 0/759 (0%) | ||
| Hyperthermia | 2/743 (0.3%) | 0/759 (0%) | ||
| Hypothermia | 1/743 (0.1%) | 0/759 (0%) | ||
| Impaired healing | 3/743 (0.4%) | 3/759 (0.4%) | ||
| Implant site pain | 1/743 (0.1%) | 0/759 (0%) | ||
| Inflammation | 0/743 (0%) | 2/759 (0.3%) | ||
| Infusion site erythema | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Infusion site extravasation | 3/743 (0.4%) | 2/759 (0.3%) | ||
| Infusion site haemorrhage | 1/743 (0.1%) | 0/759 (0%) | ||
| Infusion site inflammation | 0/743 (0%) | 1/759 (0.1%) | ||
| Infusion site pain | 4/743 (0.5%) | 3/759 (0.4%) | ||
| Infusion site swelling | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Infusion site ulcer | 0/743 (0%) | 1/759 (0.1%) | ||
| Infusion site warmth | 0/743 (0%) | 1/759 (0.1%) | ||
| Irritability | 3/743 (0.4%) | 0/759 (0%) | ||
| Local swelling | 1/743 (0.1%) | 2/759 (0.3%) | ||
| Localised oedema | 2/743 (0.3%) | 0/759 (0%) | ||
| Malaise | 2/743 (0.3%) | 1/759 (0.1%) | ||
| Non-cardiac chest pain | 8/743 (1.1%) | 14/759 (1.8%) | ||
| Oedema peripheral | 136/743 (18.3%) | 141/759 (18.6%) | ||
| Pain | 14/743 (1.9%) | 24/759 (3.2%) | ||
| Pitting oedema | 0/743 (0%) | 1/759 (0.1%) | ||
| Pyrexia | 123/743 (16.6%) | 115/759 (15.2%) | ||
| Submandibular mass | 1/743 (0.1%) | 0/759 (0%) | ||
| Wound necrosis | 1/743 (0.1%) | 0/759 (0%) | ||
| Hepatobiliary disorders | ||||
| Biliary dyskinesia | 1/743 (0.1%) | 0/759 (0%) | ||
| Cholecystitis | 3/743 (0.4%) | 1/759 (0.1%) | ||
| Cholecystitis acute | 0/743 (0%) | 1/759 (0.1%) | ||
| Cholelithiasis | 1/743 (0.1%) | 2/759 (0.3%) | ||
| Hepatic failure | 0/743 (0%) | 1/759 (0.1%) | ||
| Hepatic function abnormal | 0/743 (0%) | 1/759 (0.1%) | ||
| Hepatic ischaemia | 0/743 (0%) | 1/759 (0.1%) | ||
| Hepatic steatosis | 0/743 (0%) | 1/759 (0.1%) | ||
| Hepatitis acute | 0/743 (0%) | 1/759 (0.1%) | ||
| Hepatomegaly | 1/743 (0.1%) | 0/759 (0%) | ||
| Hyperbilirubinaemia | 1/743 (0.1%) | 0/759 (0%) | ||
| Ischaemic hepatitis | 2/743 (0.3%) | 2/759 (0.3%) | ||
| Jaundice | 2/743 (0.3%) | 1/759 (0.1%) | ||
| Portal hypertension | 1/743 (0.1%) | 0/759 (0%) | ||
| Immune system disorders | 5/743 (0.7%) | 4/759 (0.5%) | ||
| Allergic oedema | 0/743 (0%) | 1/759 (0.1%) | ||
| Allergy to chemicals | 0/743 (0%) | 1/759 (0.1%) | ||
| Drug hypersensitivity | 2/743 (0.3%) | 0/759 (0%) | ||
| Hypersensitivity | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Seasonal allergy | 2/743 (0.3%) | 1/759 (0.1%) | ||
| Infections and infestations | ||||
| Abdominal abscess | 0/743 (0%) | 1/759 (0.1%) | ||
| Abscess limb | 1/743 (0.1%) | 0/759 (0%) | ||
| Acarodermatitis | 1/743 (0.1%) | 0/759 (0%) | ||
| Acute sinusitis | 0/743 (0%) | 1/759 (0.1%) | ||
| Bacteraemia | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Bacterial disease carrier | 0/743 (0%) | 1/759 (0.1%) | ||
| Bacteriuria | 1/743 (0.1%) | 0/759 (0%) | ||
| Balanitis candida | 0/743 (0%) | 1/759 (0.1%) | ||
| Breast abscess | 0/743 (0%) | 1/759 (0.1%) | ||
| Bronchitis | 14/743 (1.9%) | 14/759 (1.8%) | ||
| Candidiasis | 6/743 (0.8%) | 2/759 (0.3%) | ||
| Candiduria | 0/743 (0%) | 1/759 (0.1%) | ||
| Catheter site infection | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Cellulitis | 15/743 (2%) | 16/759 (2.1%) | ||
| Clostridial infection | 1/743 (0.1%) | 0/759 (0%) | ||
| Clostridium difficile colitis | 0/743 (0%) | 3/759 (0.4%) | ||
| Cystitis | 1/743 (0.1%) | 2/759 (0.3%) | ||
| Cystitis klebsiella | 0/743 (0%) | 1/759 (0.1%) | ||
| Device related infection | 1/743 (0.1%) | 2/759 (0.3%) | ||
| Escherichia bacteraemia | 1/743 (0.1%) | 0/759 (0%) | ||
| Escherichia urinary tract infection | 2/743 (0.3%) | 2/759 (0.3%) | ||
| Fungal infection | 1/743 (0.1%) | 0/759 (0%) | ||
| Fungal skin infection | 2/743 (0.3%) | 1/759 (0.1%) | ||
| Gastroenteritis | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Haemophilus infection | 0/743 (0%) | 1/759 (0.1%) | ||
| Helicobacter infection | 1/743 (0.1%) | 0/759 (0%) | ||
| Hepatitis b | 1/743 (0.1%) | 0/759 (0%) | ||
| Herpes zoster | 0/743 (0%) | 1/759 (0.1%) | ||
| Incision site cellulitis | 4/743 (0.5%) | 3/759 (0.4%) | ||
| Incision site infection | 4/743 (0.5%) | 1/759 (0.1%) | ||
| Infection | 1/743 (0.1%) | 0/759 (0%) | ||
| Influenza | 4/743 (0.5%) | 1/759 (0.1%) | ||
| Infusion site infection | 0/743 (0%) | 1/759 (0.1%) | ||
| Kidney infection | 0/743 (0%) | 1/759 (0.1%) | ||
| Liver abscess | 0/743 (0%) | 1/759 (0.1%) | ||
| Lobar pneumonia | 1/743 (0.1%) | 3/759 (0.4%) | ||
| Localised infection | 1/743 (0.1%) | 0/759 (0%) | ||
| Lower respiratory tract infection | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Lung infection | 0/743 (0%) | 2/759 (0.3%) | ||
| Lung infection pseudomonal | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Mastoiditis | 0/743 (0%) | 1/759 (0.1%) | ||
| Nail infection | 0/743 (0%) | 1/759 (0.1%) | ||
| Nasopharyngitis | 2/743 (0.3%) | 4/759 (0.5%) | ||
| Oral candidiasis | 1/743 (0.1%) | 2/759 (0.3%) | ||
| Oral fungal infection | 1/743 (0.1%) | 0/759 (0%) | ||
| Oral herpes | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Pharyngitis | 0/743 (0%) | 1/759 (0.1%) | ||
| Pharyngitis streptococcal | 0/743 (0%) | 1/759 (0.1%) | ||
| Pneumonia | 24/743 (3.2%) | 16/759 (2.1%) | ||
| Pneumonia bacterial | 1/743 (0.1%) | 0/759 (0%) | ||
| Pneumonia staphylococcal | 1/743 (0.1%) | 0/759 (0%) | ||
| Pneumonia streptococcal | 1/743 (0.1%) | 0/759 (0%) | ||
| Post procedural cellulitis | 4/743 (0.5%) | 5/759 (0.7%) | ||
| Postoperative wound infection | 12/743 (1.6%) | 22/759 (2.9%) | ||
| Pseudomonas bronchitis | 1/743 (0.1%) | 0/759 (0%) | ||
| Purulent discharge | 0/743 (0%) | 1/759 (0.1%) | ||
| Respiratory tract infection | 1/743 (0.1%) | 3/759 (0.4%) | ||
| Rhinitis | 1/743 (0.1%) | 0/759 (0%) | ||
| Sepsis | 1/743 (0.1%) | 3/759 (0.4%) | ||
| Sinusitis | 8/743 (1.1%) | 8/759 (1.1%) | ||
| Skin candida | 2/743 (0.3%) | 2/759 (0.3%) | ||
| Skin infection | 0/743 (0%) | 1/759 (0.1%) | ||
| Sputum purulent | 1/743 (0.1%) | 2/759 (0.3%) | ||
| Staphylococcal bacteraemia | 0/743 (0%) | 1/759 (0.1%) | ||
| Staphylococcal mediastinitis | 0/743 (0%) | 1/759 (0.1%) | ||
| Stitch abscess | 0/743 (0%) | 2/759 (0.3%) | ||
| Subcutaneous abscess | 1/743 (0.1%) | 0/759 (0%) | ||
| Tinea cruris | 0/743 (0%) | 1/759 (0.1%) | ||
| Tooth abscess | 0/743 (0%) | 2/759 (0.3%) | ||
| Tracheobronchitis | 2/743 (0.3%) | 1/759 (0.1%) | ||
| Upper respiratory tract infection | 7/743 (0.9%) | 4/759 (0.5%) | ||
| Urinary tract infection | 33/743 (4.4%) | 48/759 (6.3%) | ||
| Urinary tract infection bacterial | 2/743 (0.3%) | 1/759 (0.1%) | ||
| Urinary tract infection pseudomonal | 2/743 (0.3%) | 1/759 (0.1%) | ||
| Vulvovaginal candidiasis | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Vulvovaginal mycotic infection | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Wound infection | 8/743 (1.1%) | 4/759 (0.5%) | ||
| Wound infection pseudomonas | 0/743 (0%) | 1/759 (0.1%) | ||
| Injury, poisoning and procedural complications | ||||
| Agitation postoperative | 0/743 (0%) | 5/759 (0.7%) | ||
| Anaemia postoperative | 43/743 (5.8%) | 49/759 (6.5%) | ||
| Ankle fracture | 0/743 (0%) | 1/759 (0.1%) | ||
| Arteriovenous fistula site haemorrhage | 1/743 (0.1%) | 0/759 (0%) | ||
| Arteriovenous fistula thrombosis | 1/743 (0.1%) | 0/759 (0%) | ||
| Arthropod bite | 1/743 (0.1%) | 0/759 (0%) | ||
| Arthropod sting | 1/743 (0.1%) | 0/759 (0%) | ||
| Brachial plexus injury | 0/743 (0%) | 1/759 (0.1%) | ||
| Cartilage injury | 1/743 (0.1%) | 0/759 (0%) | ||
| Collapse of lung | 1/743 (0.1%) | 0/759 (0%) | ||
| Confusion postoperative | 1/743 (0.1%) | 0/759 (0%) | ||
| Contusion | 7/743 (0.9%) | 5/759 (0.7%) | ||
| Device breakage | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Device dislocation | 1/743 (0.1%) | 0/759 (0%) | ||
| Device leakage | 2/743 (0.3%) | 2/759 (0.3%) | ||
| Endotracheal intubation complication | 0/743 (0%) | 1/759 (0.1%) | ||
| Excoriation | 6/743 (0.8%) | 7/759 (0.9%) | ||
| Fall | 1/743 (0.1%) | 2/759 (0.3%) | ||
| Incision site blister | 1/743 (0.1%) | 3/759 (0.4%) | ||
| Incision site complication | 0/743 (0%) | 2/759 (0.3%) | ||
| Incision site erythema | 6/743 (0.8%) | 5/759 (0.7%) | ||
| Incision site haematoma | 1/743 (0.1%) | 5/759 (0.7%) | ||
| Incision site haemorrhage | 12/743 (1.6%) | 15/759 (2%) | ||
| Incision site oedema | 0/743 (0%) | 2/759 (0.3%) | ||
| Incision site pain | 405/743 (54.5%) | 419/759 (55.2%) | ||
| Incision site pruritus | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Medical device pain | 1/743 (0.1%) | 2/759 (0.3%) | ||
| Mental status changes postoperative | 0/743 (0%) | 1/759 (0.1%) | ||
| Muscle strain | 0/743 (0%) | 1/759 (0.1%) | ||
| Open wound | 1/743 (0.1%) | 0/759 (0%) | ||
| Operative haemorrhage | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Pelvic fracture | 0/743 (0%) | 1/759 (0.1%) | ||
| Post procedural complication | 3/743 (0.4%) | 1/759 (0.1%) | ||
| Post procedural discharge | 55/743 (7.4%) | 58/759 (7.6%) | ||
| Post procedural haematoma | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Post procedural haematuria | 0/743 (0%) | 1/759 (0.1%) | ||
| Post procedural haemorrhage | 8/743 (1.1%) | 19/759 (2.5%) | ||
| Post procedural myocardial infarction | 2/743 (0.3%) | 3/759 (0.4%) | ||
| Post procedural oedema | 1/743 (0.1%) | 0/759 (0%) | ||
| Postoperative ileus | 2/743 (0.3%) | 2/759 (0.3%) | ||
| Postoperative thoracic procedure complication | 4/743 (0.5%) | 6/759 (0.8%) | ||
| Postoperative wound complication | 11/743 (1.5%) | 20/759 (2.6%) | ||
| Postpericardiotomy syndrome | 1/743 (0.1%) | 2/759 (0.3%) | ||
| Procedural complication | 1/743 (0.1%) | 0/759 (0%) | ||
| Procedural hypertension | 1/743 (0.1%) | 3/759 (0.4%) | ||
| Procedural hypotension | 6/743 (0.8%) | 7/759 (0.9%) | ||
| Procedural nausea | 1/743 (0.1%) | 5/759 (0.7%) | ||
| Procedural pain | 182/743 (24.5%) | 169/759 (22.3%) | ||
| Rib fracture | 0/743 (0%) | 1/759 (0.1%) | ||
| Seroma | 1/743 (0.1%) | 3/759 (0.4%) | ||
| Skin laceration | 9/743 (1.2%) | 8/759 (1.1%) | ||
| Surgical skin tear | 0/743 (0%) | 1/759 (0.1%) | ||
| Suture rupture | 0/743 (0%) | 1/759 (0.1%) | ||
| Synovial rupture | 1/743 (0.1%) | 0/759 (0%) | ||
| Therapeutic agent toxicity | 0/743 (0%) | 1/759 (0.1%) | ||
| Thermal burn | 1/743 (0.1%) | 0/759 (0%) | ||
| Thrombosis in device | 1/743 (0.1%) | 0/759 (0%) | ||
| Transfusion reaction | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Upper limb fracture | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Urethral injury | 1/743 (0.1%) | 0/759 (0%) | ||
| Urinary retention postoperative | 0/743 (0%) | 1/759 (0.1%) | ||
| Vascular graft occlusion | 0/743 (0%) | 1/759 (0.1%) | ||
| Vascular pseudoaneurysm | 1/743 (0.1%) | 0/759 (0%) | ||
| Vasoplegia syndrome | 1/743 (0.1%) | 0/759 (0%) | ||
| Wound | 3/743 (0.4%) | 1/759 (0.1%) | ||
| Wound complication | 0/743 (0%) | 1/759 (0.1%) | ||
| Wound dehiscence | 9/743 (1.2%) | 11/759 (1.4%) | ||
| Investigations | ||||
| Acid base balance abnormal | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Activated partial thromboplastin time prolonged | 2/743 (0.3%) | 4/759 (0.5%) | ||
| Alanine aminotransferase decreased | 2/743 (0.3%) | 0/759 (0%) | ||
| Alanine aminotransferase increased | 2/743 (0.3%) | 1/759 (0.1%) | ||
| Ammonia increased | 1/743 (0.1%) | 0/759 (0%) | ||
| Anticoagulation drug level below therapeutic | 0/743 (0%) | 1/759 (0.1%) | ||
| Aspartate aminotransferase increased | 9/743 (1.2%) | 5/759 (0.7%) | ||
| Aspiration bronchial | 0/743 (0%) | 1/759 (0.1%) | ||
| Bacteria sputum identified | 17/743 (2.3%) | 8/759 (1.1%) | ||
| Bacterial culture positive | 3/743 (0.4%) | 13/759 (1.7%) | ||
| Base excess increased | 1/743 (0.1%) | 0/759 (0%) | ||
| Basophil count increased | 0/743 (0%) | 1/759 (0.1%) | ||
| Blood albumin decreased | 12/743 (1.6%) | 9/759 (1.2%) | ||
| Blood alkaline phosphatase decreased | 4/743 (0.5%) | 3/759 (0.4%) | ||
| Blood alkaline phosphatase increased | 1/743 (0.1%) | 0/759 (0%) | ||
| Blood bicarbonate decreased | 0/743 (0%) | 2/759 (0.3%) | ||
| Blood bicarbonate increased | 1/743 (0.1%) | 0/759 (0%) | ||
| Blood bilirubin increased | 3/743 (0.4%) | 0/759 (0%) | ||
| Blood calcium decreased | 21/743 (2.8%) | 19/759 (2.5%) | ||
| Blood calcium increased | 1/743 (0.1%) | 2/759 (0.3%) | ||
| Blood chloride decreased | 0/743 (0%) | 2/759 (0.3%) | ||
| Blood chloride increased | 7/743 (0.9%) | 5/759 (0.7%) | ||
| Blood cortisol decreased | 0/743 (0%) | 1/759 (0.1%) | ||
| Blood creatine increased | 3/743 (0.4%) | 2/759 (0.3%) | ||
| Blood creatine phosphokinase increased | 2/743 (0.3%) | 2/759 (0.3%) | ||
| Blood creatine phosphokinase mb increased | 2/743 (0.3%) | 0/759 (0%) | ||
| Blood creatinine decreased | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Blood creatinine increased | 44/743 (5.9%) | 38/759 (5%) | ||
| Blood fibrinogen decreased | 1/743 (0.1%) | 0/759 (0%) | ||
| Blood glucose fluctuation | 11/743 (1.5%) | 14/759 (1.8%) | ||
| Blood glucose increased | 23/743 (3.1%) | 26/759 (3.4%) | ||
| Blood lactic acid increased | 0/743 (0%) | 5/759 (0.7%) | ||
| Blood magnesium decreased | 13/743 (1.7%) | 6/759 (0.8%) | ||
| Blood magnesium increased | 10/743 (1.3%) | 10/759 (1.3%) | ||
| Blood ph decreased | 0/743 (0%) | 2/759 (0.3%) | ||
| Blood phosphorus decreased | 2/743 (0.3%) | 2/759 (0.3%) | ||
| Blood phosphorus increased | 2/743 (0.3%) | 2/759 (0.3%) | ||
| Blood potassium decreased | 5/743 (0.7%) | 4/759 (0.5%) | ||
| Blood potassium increased | 5/743 (0.7%) | 11/759 (1.4%) | ||
| Blood pressure decreased | 3/743 (0.4%) | 5/759 (0.7%) | ||
| Blood pressure increased | 5/743 (0.7%) | 10/759 (1.3%) | ||
| Blood pressure systolic decreased | 1/743 (0.1%) | 0/759 (0%) | ||
| Blood pressure systolic increased | 1/743 (0.1%) | 0/759 (0%) | ||
| Blood sodium decreased | 7/743 (0.9%) | 8/759 (1.1%) | ||
| Blood sodium increased | 2/743 (0.3%) | 2/759 (0.3%) | ||
| Blood thyroid stimulating hormone increased | 2/743 (0.3%) | 0/759 (0%) | ||
| Blood urea increased | 38/743 (5.1%) | 35/759 (4.6%) | ||
| Blood urea nitrogen/creatinine ratio increased | 1/743 (0.1%) | 0/759 (0%) | ||
| Blood urine present | 1/743 (0.1%) | 2/759 (0.3%) | ||
| Body temperature decreased | 1/743 (0.1%) | 0/759 (0%) | ||
| Body temperature increased | 55/743 (7.4%) | 53/759 (7%) | ||
| Brain natriuretic peptide increased | 4/743 (0.5%) | 4/759 (0.5%) | ||
| Breath sounds abnormal | 56/743 (7.5%) | 56/759 (7.4%) | ||
| C-reactive protein increased | 1/743 (0.1%) | 0/759 (0%) | ||
| Calcium ionised decreased | 21/743 (2.8%) | 24/759 (3.2%) | ||
| Carbon dioxide decreased | 2/743 (0.3%) | 0/759 (0%) | ||
| Carbon dioxide increased | 4/743 (0.5%) | 5/759 (0.7%) | ||
| Cardiac enzymes increased | 2/743 (0.3%) | 3/759 (0.4%) | ||
| Cardiac index decreased | 18/743 (2.4%) | 18/759 (2.4%) | ||
| Cardiac murmur | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Cardiac output decreased | 6/743 (0.8%) | 7/759 (0.9%) | ||
| Cardioactive drug level decreased | 1/743 (0.1%) | 0/759 (0%) | ||
| Central venous pressure decreased | 5/743 (0.7%) | 2/759 (0.3%) | ||
| Chest x-ray abnormal | 7/743 (0.9%) | 5/759 (0.7%) | ||
| Clostridium difficile toxin test positive | 0/743 (0%) | 1/759 (0.1%) | ||
| Computerised tomogram abdomen abnormal | 0/743 (0%) | 1/759 (0.1%) | ||
| Ejection fraction decreased | 0/743 (0%) | 2/759 (0.3%) | ||
| Electrocardiogram abnormal | 0/743 (0%) | 1/759 (0.1%) | ||
| Electrocardiogram st segment depression | 0/743 (0%) | 1/759 (0.1%) | ||
| Electrocardiogram st segment elevation | 7/743 (0.9%) | 8/759 (1.1%) | ||
| Fibrin d dimer increased | 0/743 (0%) | 1/759 (0.1%) | ||
| Fungus sputum test positive | 0/743 (0%) | 3/759 (0.4%) | ||
| Glycosylated haemoglobin increased | 0/743 (0%) | 1/759 (0.1%) | ||
| Grip strength decreased | 1/743 (0.1%) | 0/759 (0%) | ||
| Haematocrit decreased | 28/743 (3.8%) | 38/759 (5%) | ||
| Haemoglobin decreased | 20/743 (2.7%) | 26/759 (3.4%) | ||
| Heart rate decreased | 3/743 (0.4%) | 2/759 (0.3%) | ||
| Heart rate increased | 3/743 (0.4%) | 2/759 (0.3%) | ||
| Heart rate irregular | 1/743 (0.1%) | 2/759 (0.3%) | ||
| Heart sounds abnormal | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Hepatic enzyme increased | 3/743 (0.4%) | 2/759 (0.3%) | ||
| International normalised ratio decreased | 0/743 (0%) | 1/759 (0.1%) | ||
| International normalised ratio increased | 3/743 (0.4%) | 2/759 (0.3%) | ||
| Lipase increased | 1/743 (0.1%) | 0/759 (0%) | ||
| Liver function test abnormal | 8/743 (1.1%) | 6/759 (0.8%) | ||
| Lymphocyte count decreased | 12/743 (1.6%) | 7/759 (0.9%) | ||
| Mean arterial pressure decreased | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Methicillin-resistant staphylococcal aureus test positive | 2/743 (0.3%) | 7/759 (0.9%) | ||
| Monocyte count increased | 3/743 (0.4%) | 1/759 (0.1%) | ||
| Myoglobin blood increased | 0/743 (0%) | 1/759 (0.1%) | ||
| Neutrophil count increased | 8/743 (1.1%) | 7/759 (0.9%) | ||
| Occult blood | 0/743 (0%) | 1/759 (0.1%) | ||
| Occult blood positive | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Oxygen saturation decreased | 12/743 (1.6%) | 8/759 (1.1%) | ||
| Platelet count decreased | 13/743 (1.7%) | 13/759 (1.7%) | ||
| Platelet count increased | 3/743 (0.4%) | 6/759 (0.8%) | ||
| Protein total decreased | 8/743 (1.1%) | 6/759 (0.8%) | ||
| Prothrombin time prolonged | 5/743 (0.7%) | 3/759 (0.4%) | ||
| Prothrombin time ratio increased | 0/743 (0%) | 1/759 (0.1%) | ||
| Pulmonary arterial pressure decreased | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Pulmonary arterial pressure increased | 2/743 (0.3%) | 0/759 (0%) | ||
| Pulmonary arterial wedge pressure increased | 0/743 (0%) | 1/759 (0.1%) | ||
| Pulse absent | 0/743 (0%) | 2/759 (0.3%) | ||
| Pulse pressure decreased | 0/743 (0%) | 1/759 (0.1%) | ||
| Red blood cell count decreased | 11/743 (1.5%) | 10/759 (1.3%) | ||
| Serum ferritin increased | 1/743 (0.1%) | 0/759 (0%) | ||
| Sputum abnormal | 0/743 (0%) | 2/759 (0.3%) | ||
| Staphylococcal identification test positive | 0/743 (0%) | 2/759 (0.3%) | ||
| Streptococcal identification test positive | 1/743 (0.1%) | 2/759 (0.3%) | ||
| Transaminases increased | 1/743 (0.1%) | 0/759 (0%) | ||
| Troponin i increased | 0/743 (0%) | 2/759 (0.3%) | ||
| Troponin increased | 10/743 (1.3%) | 5/759 (0.7%) | ||
| Urinary sediment present | 1/743 (0.1%) | 0/759 (0%) | ||
| Urine analysis abnormal | 0/743 (0%) | 1/759 (0.1%) | ||
| Urine colour abnormal | 2/743 (0.3%) | 0/759 (0%) | ||
| Urine output decreased | 51/743 (6.9%) | 65/759 (8.6%) | ||
| Vascular resistance systemic decreased | 0/743 (0%) | 1/759 (0.1%) | ||
| Vascular resistance systemic increased | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Venous oxygen saturation decreased | 0/743 (0%) | 2/759 (0.3%) | ||
| Venous pressure increased | 1/743 (0.1%) | 0/759 (0%) | ||
| Weight decreased | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Weight increased | 2/743 (0.3%) | 0/759 (0%) | ||
| White blood cell count decreased | 0/743 (0%) | 2/759 (0.3%) | ||
| White blood cell count increased | 112/743 (15.1%) | 105/759 (13.8%) | ||
| Metabolism and nutrition disorders | ||||
| Acidosis | 3/743 (0.4%) | 2/759 (0.3%) | ||
| Anorexia | 5/743 (0.7%) | 6/759 (0.8%) | ||
| Decreased appetite | 28/743 (3.8%) | 22/759 (2.9%) | ||
| Dehydration | 3/743 (0.4%) | 2/759 (0.3%) | ||
| Diabetes mellitus | 17/743 (2.3%) | 14/759 (1.8%) | ||
| Diabetes mellitus inadequate control | 0/743 (0%) | 3/759 (0.4%) | ||
| Fluid overload | 57/743 (7.7%) | 59/759 (7.8%) | ||
| Fluid retention | 3/743 (0.4%) | 3/759 (0.4%) | ||
| Glucose tolerance impaired | 3/743 (0.4%) | 3/759 (0.4%) | ||
| Gout | 1/743 (0.1%) | 6/759 (0.8%) | ||
| Hypercalcaemia | 0/743 (0%) | 2/759 (0.3%) | ||
| Hyperchloraemia | 3/743 (0.4%) | 1/759 (0.1%) | ||
| Hyperglycaemia | 152/743 (20.5%) | 142/759 (18.7%) | ||
| Hyperkalaemia | 73/743 (9.8%) | 59/759 (7.8%) | ||
| Hyperlipidaemia | 0/743 (0%) | 1/759 (0.1%) | ||
| Hypermagnesaemia | 10/743 (1.3%) | 15/759 (2%) | ||
| Hypernatraemia | 4/743 (0.5%) | 9/759 (1.2%) | ||
| Hyperphosphataemia | 1/743 (0.1%) | 0/759 (0%) | ||
| Hypervolaemia | 1/743 (0.1%) | 2/759 (0.3%) | ||
| Hypoalbuminaemia | 3/743 (0.4%) | 2/759 (0.3%) | ||
| Hypocalcaemia | 102/743 (13.7%) | 98/759 (12.9%) | ||
| Hypochloraemia | 3/743 (0.4%) | 2/759 (0.3%) | ||
| Hypoglycaemia | 58/743 (7.8%) | 50/759 (6.6%) | ||
| Hypokalaemia | 112/743 (15.1%) | 130/759 (17.1%) | ||
| Hypomagnesaemia | 18/743 (2.4%) | 19/759 (2.5%) | ||
| Hyponatraemia | 47/743 (6.3%) | 47/759 (6.2%) | ||
| Hypophosphataemia | 5/743 (0.7%) | 6/759 (0.8%) | ||
| Hypoproteinaemia | 0/743 (0%) | 1/759 (0.1%) | ||
| Hypovolaemia | 5/743 (0.7%) | 4/759 (0.5%) | ||
| Iron deficiency | 0/743 (0%) | 1/759 (0.1%) | ||
| Lactic acidosis | 2/743 (0.3%) | 1/759 (0.1%) | ||
| Malnutrition | 10/743 (1.3%) | 8/759 (1.1%) | ||
| Metabolic acidosis | 11/743 (1.5%) | 8/759 (1.1%) | ||
| Metabolic alkalosis | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Metabolic syndrome | 1/743 (0.1%) | 2/759 (0.3%) | ||
| Type 1 diabetes mellitus | 0/743 (0%) | 1/759 (0.1%) | ||
| Type 2 diabetes mellitus | 1/743 (0.1%) | 3/759 (0.4%) | ||
| Vitamin d deficiency | 3/743 (0.4%) | 1/759 (0.1%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 7/743 (0.9%) | 10/759 (1.3%) | ||
| Arthritis | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Back pain | 47/743 (6.3%) | 35/759 (4.6%) | ||
| Bone pain | 0/743 (0%) | 1/759 (0.1%) | ||
| Coccydynia | 1/743 (0.1%) | 0/759 (0%) | ||
| Costochondritis | 1/743 (0.1%) | 0/759 (0%) | ||
| Flank pain | 3/743 (0.4%) | 4/759 (0.5%) | ||
| Joint crepitation | 2/743 (0.3%) | 0/759 (0%) | ||
| Joint swelling | 2/743 (0.3%) | 1/759 (0.1%) | ||
| Lower extremity mass | 2/743 (0.3%) | 0/759 (0%) | ||
| Mobility decreased | 3/743 (0.4%) | 0/759 (0%) | ||
| Muscle spasms | 4/743 (0.5%) | 7/759 (0.9%) | ||
| Muscle twitching | 0/743 (0%) | 1/759 (0.1%) | ||
| Muscular weakness | 14/743 (1.9%) | 14/759 (1.8%) | ||
| Musculoskeletal chest pain | 28/743 (3.8%) | 27/759 (3.6%) | ||
| Musculoskeletal discomfort | 3/743 (0.4%) | 1/759 (0.1%) | ||
| Musculoskeletal disorder | 1/743 (0.1%) | 0/759 (0%) | ||
| Musculoskeletal pain | 27/743 (3.6%) | 33/759 (4.3%) | ||
| Myalgia | 5/743 (0.7%) | 6/759 (0.8%) | ||
| Neck pain | 9/743 (1.2%) | 5/759 (0.7%) | ||
| Osteoarthritis | 1/743 (0.1%) | 2/759 (0.3%) | ||
| Pain in extremity | 24/743 (3.2%) | 33/759 (4.3%) | ||
| Pain in jaw | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Plantar fasciitis | 1/743 (0.1%) | 0/759 (0%) | ||
| Rotator cuff syndrome | 0/743 (0%) | 2/759 (0.3%) | ||
| Soft tissue disorder | 2/743 (0.3%) | 3/759 (0.4%) | ||
| Synovial cyst | 1/743 (0.1%) | 0/759 (0%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Basal cell carcinoma | 1/743 (0.1%) | 0/759 (0%) | ||
| Chronic lymphocytic leukaemia | 1/743 (0.1%) | 0/759 (0%) | ||
| Hepatic neoplasm | 1/743 (0.1%) | 0/759 (0%) | ||
| Lung neoplasm | 3/743 (0.4%) | 1/759 (0.1%) | ||
| Lung neoplasm malignant | 1/743 (0.1%) | 0/759 (0%) | ||
| Thyroid neoplasm | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Nervous system disorders | ||||
| Aphasia | 2/743 (0.3%) | 1/759 (0.1%) | ||
| Balance disorder | 3/743 (0.4%) | 1/759 (0.1%) | ||
| Burning sensation | 2/743 (0.3%) | 1/759 (0.1%) | ||
| Carotid arteriosclerosis | 1/743 (0.1%) | 0/759 (0%) | ||
| Carotid artery stenosis | 2/743 (0.3%) | 0/759 (0%) | ||
| Cerebellar infarction | 0/743 (0%) | 1/759 (0.1%) | ||
| Cerebral cyst | 1/743 (0.1%) | 0/759 (0%) | ||
| Cerebral infarction | 0/743 (0%) | 1/759 (0.1%) | ||
| Convulsion | 1/743 (0.1%) | 3/759 (0.4%) | ||
| Depressed level of consciousness | 1/743 (0.1%) | 2/759 (0.3%) | ||
| Dizziness | 24/743 (3.2%) | 38/759 (5%) | ||
| Dizziness exertional | 2/743 (0.3%) | 0/759 (0%) | ||
| Dysarthria | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Dysgeusia | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Dysphasia | 1/743 (0.1%) | 0/759 (0%) | ||
| Encephalopathy | 5/743 (0.7%) | 5/759 (0.7%) | ||
| Facial palsy | 0/743 (0%) | 1/759 (0.1%) | ||
| Headache | 38/743 (5.1%) | 22/759 (2.9%) | ||
| Hemiparesis | 2/743 (0.3%) | 2/759 (0.3%) | ||
| Hepatic encephalopathy | 0/743 (0%) | 1/759 (0.1%) | ||
| Hyperaesthesia | 0/743 (0%) | 1/759 (0.1%) | ||
| Hypoaesthesia | 19/743 (2.6%) | 20/759 (2.6%) | ||
| Hypotonia | 0/743 (0%) | 1/759 (0.1%) | ||
| Lethargy | 16/743 (2.2%) | 16/759 (2.1%) | ||
| Loss of consciousness | 1/743 (0.1%) | 0/759 (0%) | ||
| Memory impairment | 2/743 (0.3%) | 1/759 (0.1%) | ||
| Metabolic encephalopathy | 1/743 (0.1%) | 2/759 (0.3%) | ||
| Migraine | 1/743 (0.1%) | 0/759 (0%) | ||
| Nerve compression | 0/743 (0%) | 1/759 (0.1%) | ||
| Neuralgia | 4/743 (0.5%) | 1/759 (0.1%) | ||
| Neuropathy peripheral | 1/743 (0.1%) | 3/759 (0.4%) | ||
| Paraesthesia | 4/743 (0.5%) | 3/759 (0.4%) | ||
| Peripheral sensory neuropathy | 0/743 (0%) | 1/759 (0.1%) | ||
| Presyncope | 2/743 (0.3%) | 1/759 (0.1%) | ||
| Restless legs syndrome | 0/743 (0%) | 1/759 (0.1%) | ||
| Sedation | 0/743 (0%) | 3/759 (0.4%) | ||
| Somnolence | 4/743 (0.5%) | 2/759 (0.3%) | ||
| Syncope | 2/743 (0.3%) | 5/759 (0.7%) | ||
| Thalamic infarction | 1/743 (0.1%) | 0/759 (0%) | ||
| Transient ischaemic attack | 1/743 (0.1%) | 2/759 (0.3%) | ||
| Tremor | 2/743 (0.3%) | 3/759 (0.4%) | ||
| Unresponsive to stimuli | 1/743 (0.1%) | 0/759 (0%) | ||
| Upper motor neurone lesion | 1/743 (0.1%) | 0/759 (0%) | ||
| Psychiatric disorders | ||||
| Abnormal dreams | 0/743 (0%) | 1/759 (0.1%) | ||
| Aggression | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Agitation | 27/743 (3.6%) | 24/759 (3.2%) | ||
| Anxiety | 60/743 (8.1%) | 40/759 (5.3%) | ||
| Claustrophobia | 0/743 (0%) | 1/759 (0.1%) | ||
| Confusional state | 57/743 (7.7%) | 61/759 (8%) | ||
| Delirium | 4/743 (0.5%) | 3/759 (0.4%) | ||
| Depressed mood | 1/743 (0.1%) | 0/759 (0%) | ||
| Depression | 12/743 (1.6%) | 11/759 (1.4%) | ||
| Disorientation | 8/743 (1.1%) | 5/759 (0.7%) | ||
| Hallucination | 7/743 (0.9%) | 6/759 (0.8%) | ||
| Hallucination, visual | 3/743 (0.4%) | 7/759 (0.9%) | ||
| Insomnia | 4/743 (0.5%) | 52/759 (6.9%) | ||
| Mania | 0/743 (0%) | 1/759 (0.1%) | ||
| Mental status changes | 12/743 (1.6%) | 11/759 (1.4%) | ||
| Mood altered | 1/743 (0.1%) | 0/759 (0%) | ||
| Nervousness | 0/743 (0%) | 1/759 (0.1%) | ||
| Paranoia | 1/743 (0.1%) | 2/759 (0.3%) | ||
| Psychotic disorder | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Restlessness | 16/743 (2.2%) | 17/759 (2.2%) | ||
| Sleep disorder | 2/743 (0.3%) | 1/759 (0.1%) | ||
| Stress | 0/743 (0%) | 1/759 (0.1%) | ||
| Renal and urinary disorders | ||||
| Acute prerenal failure | 2/743 (0.3%) | 0/759 (0%) | ||
| Anuria | 0/743 (0%) | 1/759 (0.1%) | ||
| Azotaemia | 2/743 (0.3%) | 0/759 (0%) | ||
| Bladder fibrosis | 1/743 (0.1%) | 0/759 (0%) | ||
| Bladder spasm | 2/743 (0.3%) | 1/759 (0.1%) | ||
| Chromaturia | 3/743 (0.4%) | 5/759 (0.7%) | ||
| Dysuria | 11/743 (1.5%) | 4/759 (0.5%) | ||
| Haematuria | 15/743 (2%) | 12/759 (1.6%) | ||
| Micturition urgency | 1/743 (0.1%) | 3/759 (0.4%) | ||
| Nephrolithiasis | 3/743 (0.4%) | 1/759 (0.1%) | ||
| Neurogenic bladder | 1/743 (0.1%) | 0/759 (0%) | ||
| Nocturia | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Oliguria | 12/743 (1.6%) | 11/759 (1.4%) | ||
| Pollakiuria | 2/743 (0.3%) | 1/759 (0.1%) | ||
| Polyuria | 2/743 (0.3%) | 1/759 (0.1%) | ||
| Proteinuria | 2/743 (0.3%) | 0/759 (0%) | ||
| Renal cyst | 1/743 (0.1%) | 0/759 (0%) | ||
| Renal disorder | 1/743 (0.1%) | 0/759 (0%) | ||
| Renal failure | 60/743 (8.1%) | 48/759 (6.3%) | ||
| Renal failure acute | 26/743 (3.5%) | 34/759 (4.5%) | ||
| Renal failure chronic | 5/743 (0.7%) | 2/759 (0.3%) | ||
| Renal impairment | 1/743 (0.1%) | 2/759 (0.3%) | ||
| Renal mass | 0/743 (0%) | 1/759 (0.1%) | ||
| Renal tubular necrosis | 1/743 (0.1%) | 2/759 (0.3%) | ||
| Urinary incontinence | 8/743 (1.1%) | 13/759 (1.7%) | ||
| Urinary retention | 15/743 (2%) | 15/759 (2%) | ||
| Urinary tract obstruction | 0/743 (0%) | 1/759 (0.1%) | ||
| Urine abnormality | 2/743 (0.3%) | 2/759 (0.3%) | ||
| Reproductive system and breast disorders | ||||
| Benign prostatic hyperplasia | 1/743 (0.1%) | 0/759 (0%) | ||
| Breast pain | 1/743 (0.1%) | 0/759 (0%) | ||
| Genital erythema | 1/743 (0.1%) | 0/759 (0%) | ||
| Genital rash | 1/743 (0.1%) | 0/759 (0%) | ||
| Penile oedema | 0/743 (0%) | 1/759 (0.1%) | ||
| Perineal pain | 0/743 (0%) | 1/759 (0.1%) | ||
| Prostatomegaly | 1/743 (0.1%) | 0/759 (0%) | ||
| Scrotal erythema | 0/743 (0%) | 1/759 (0.1%) | ||
| Scrotal haematocoele | 1/743 (0.1%) | 0/759 (0%) | ||
| Scrotal oedema | 1/743 (0.1%) | 2/759 (0.3%) | ||
| Scrotal swelling | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Testicular pain | 1/743 (0.1%) | 0/759 (0%) | ||
| Uterine haemorrhage | 1/743 (0.1%) | 0/759 (0%) | ||
| Vaginal discharge | 2/743 (0.3%) | 1/759 (0.1%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Acquired diaphragmatic eventration | 2/743 (0.3%) | 1/759 (0.1%) | ||
| Acute pulmonary oedema | 0/743 (0%) | 1/759 (0.1%) | ||
| Acute respiratory failure | 6/743 (0.8%) | 7/759 (0.9%) | ||
| Apnoea | 0/743 (0%) | 2/759 (0.3%) | ||
| Aspiration | 2/743 (0.3%) | 4/759 (0.5%) | ||
| Asthma | 0/743 (0%) | 2/759 (0.3%) | ||
| Atelectasis | 270/743 (36.3%) | 283/759 (37.3%) | ||
| Bronchial hyperreactivity | 0/743 (0%) | 1/759 (0.1%) | ||
| Bronchial oedema | 1/743 (0.1%) | 0/759 (0%) | ||
| Bronchospasm | 1/743 (0.1%) | 0/759 (0%) | ||
| Bullous lung disease | 1/743 (0.1%) | 0/759 (0%) | ||
| Chronic obstructive pulmonary disease | 8/743 (1.1%) | 3/759 (0.4%) | ||
| Chronic respiratory failure | 1/743 (0.1%) | 0/759 (0%) | ||
| Chylothorax | 1/743 (0.1%) | 0/759 (0%) | ||
| Cough | 63/743 (8.5%) | 58/759 (7.6%) | ||
| Cough decreased | 0/743 (0%) | 1/759 (0.1%) | ||
| Diaphragmatic paralysis | 0/743 (0%) | 1/759 (0.1%) | ||
| Dysphonia | 9/743 (1.2%) | 5/759 (0.7%) | ||
| Dyspnoea | 65/743 (8.7%) | 60/759 (7.9%) | ||
| Dyspnoea exertional | 14/743 (1.9%) | 10/759 (1.3%) | ||
| Epistaxis | 4/743 (0.5%) | 8/759 (1.1%) | ||
| Haemoptysis | 6/743 (0.8%) | 3/759 (0.4%) | ||
| Haemothorax | 2/743 (0.3%) | 1/759 (0.1%) | ||
| Hiccups | 2/743 (0.3%) | 3/759 (0.4%) | ||
| Hydropneumothorax | 0/743 (0%) | 2/759 (0.3%) | ||
| Hypercapnia | 1/743 (0.1%) | 0/759 (0%) | ||
| Hyperventilation | 0/743 (0%) | 1/759 (0.1%) | ||
| Hypoventilation | 1/743 (0.1%) | 0/759 (0%) | ||
| Hypoxia | 48/743 (6.5%) | 42/759 (5.5%) | ||
| Interstitial lung disease | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Laryngeal oedema | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Lung consolidation | 2/743 (0.3%) | 1/759 (0.1%) | ||
| Lung hyperinflation | 0/743 (0%) | 1/759 (0.1%) | ||
| Lung infiltration | 18/743 (2.4%) | 14/759 (1.8%) | ||
| Mediastinal disorder | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Mediastinal haematoma | 2/743 (0.3%) | 0/759 (0%) | ||
| Mediastinal haemorrhage | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Nasal congestion | 0/743 (0%) | 2/759 (0.3%) | ||
| Obstructive airways disorder | 1/743 (0.1%) | 0/759 (0%) | ||
| Oropharyngeal blistering | 2/743 (0.3%) | 0/759 (0%) | ||
| Oropharyngeal discomfort | 0/743 (0%) | 1/759 (0.1%) | ||
| Oropharyngeal pain | 9/743 (1.2%) | 12/759 (1.6%) | ||
| Orthopnoea | 1/743 (0.1%) | 2/759 (0.3%) | ||
| Painful respiration | 0/743 (0%) | 1/759 (0.1%) | ||
| Paranasal sinus hypersecretion | 1/743 (0.1%) | 0/759 (0%) | ||
| Pharyngeal haematoma | 1/743 (0.1%) | 0/759 (0%) | ||
| Pleural effusion | 281/743 (37.8%) | 277/759 (36.5%) | ||
| Pleural rub | 4/743 (0.5%) | 2/759 (0.3%) | ||
| Pleuritic pain | 1/743 (0.1%) | 0/759 (0%) | ||
| Pneumomediastinum | 1/743 (0.1%) | 0/759 (0%) | ||
| Pneumonia aspiration | 1/743 (0.1%) | 0/759 (0%) | ||
| Pneumonitis | 1/743 (0.1%) | 0/759 (0%) | ||
| Pneumothorax | 55/743 (7.4%) | 46/759 (6.1%) | ||
| Postnasal drip | 1/743 (0.1%) | 0/759 (0%) | ||
| Productive cough | 56/743 (7.5%) | 41/759 (5.4%) | ||
| Pulmonary congestion | 65/743 (8.7%) | 53/759 (7%) | ||
| Pulmonary embolism | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Pulmonary haemorrhage | 1/743 (0.1%) | 0/759 (0%) | ||
| Pulmonary hypertension | 4/743 (0.5%) | 4/759 (0.5%) | ||
| Pulmonary oedema | 67/743 (9%) | 73/759 (9.6%) | ||
| Pulmonary vascular disorder | 1/743 (0.1%) | 0/759 (0%) | ||
| Rales | 32/743 (4.3%) | 19/759 (2.5%) | ||
| Respiratory acidosis | 10/743 (1.3%) | 7/759 (0.9%) | ||
| Respiratory alkalosis | 2/743 (0.3%) | 3/759 (0.4%) | ||
| Respiratory distress | 3/743 (0.4%) | 2/759 (0.3%) | ||
| Respiratory failure | 45/743 (6.1%) | 32/759 (4.2%) | ||
| Respiratory tract congestion | 2/743 (0.3%) | 0/759 (0%) | ||
| Rhinitis allergic | 0/743 (0%) | 1/759 (0.1%) | ||
| Rhonchi | 14/743 (1.9%) | 18/759 (2.4%) | ||
| Sleep apnoea syndrome | 2/743 (0.3%) | 3/759 (0.4%) | ||
| Sputum discoloured | 3/743 (0.4%) | 1/759 (0.1%) | ||
| Stridor | 1/743 (0.1%) | 0/759 (0%) | ||
| Tachypnoea | 4/743 (0.5%) | 7/759 (0.9%) | ||
| Wheezing | 27/743 (3.6%) | 15/759 (2%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Alopecia | 0/743 (0%) | 1/759 (0.1%) | ||
| Blister | 6/743 (0.8%) | 10/759 (1.3%) | ||
| Cold sweat | 2/743 (0.3%) | 1/759 (0.1%) | ||
| Decubitus ulcer | 9/743 (1.2%) | 8/759 (1.1%) | ||
| Dermatitis | 1/743 (0.1%) | 0/759 (0%) | ||
| Dermatitis contact | 9/743 (1.2%) | 6/759 (0.8%) | ||
| Diabetic bullosis | 0/743 (0%) | 1/759 (0.1%) | ||
| Dry skin | 0/743 (0%) | 1/759 (0.1%) | ||
| Ecchymosis | 10/743 (1.3%) | 16/759 (2.1%) | ||
| Erythema | 9/743 (1.2%) | 12/759 (1.6%) | ||
| Heat rash | 0/743 (0%) | 1/759 (0.1%) | ||
| Hyperhidrosis | 15/743 (2%) | 10/759 (1.3%) | ||
| Hypoaesthesia facial | 1/743 (0.1%) | 0/759 (0%) | ||
| Livedo reticularis | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Penile ulceration | 1/743 (0.1%) | 0/759 (0%) | ||
| Periorbital oedema | 1/743 (0.1%) | 0/759 (0%) | ||
| Petechiae | 0/743 (0%) | 2/759 (0.3%) | ||
| Pruritus | 9/743 (1.2%) | 7/759 (0.9%) | ||
| Pruritus allergic | 0/743 (0%) | 1/759 (0.1%) | ||
| Pruritus generalised | 1/743 (0.1%) | 0/759 (0%) | ||
| Rash | 13/743 (1.7%) | 15/759 (2%) | ||
| Rash erythematous | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Rash generalised | 1/743 (0.1%) | 2/759 (0.3%) | ||
| Rash maculo-papular | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Rash papular | 0/743 (0%) | 1/759 (0.1%) | ||
| Skin burning sensation | 1/743 (0.1%) | 0/759 (0%) | ||
| Skin discolouration | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Skin disorder | 4/743 (0.5%) | 8/759 (1.1%) | ||
| Skin ulcer | 4/743 (0.5%) | 4/759 (0.5%) | ||
| Stasis dermatitis | 0/743 (0%) | 1/759 (0.1%) | ||
| Subcutaneous emphysema | 5/743 (0.7%) | 4/759 (0.5%) | ||
| Urticaria | 3/743 (0.4%) | 0/759 (0%) | ||
| Vascular disorders | ||||
| Vascular disorders | 253/743 (34.1%) | 265/759 (34.9%) | ||
| Aortic aneurysm | 0/743 (0%) | 1/759 (0.1%) | ||
| Aortic arteriosclerosis | 1/743 (0.1%) | 0/759 (0%) | ||
| Blood pressure fluctuation | 2/743 (0.3%) | 0/759 (0%) | ||
| Deep vein thrombosis | 2/743 (0.3%) | 6/759 (0.8%) | ||
| Femoral artery aneurysm | 0/743 (0%) | 1/759 (0.1%) | ||
| Flushing | 3/743 (0.4%) | 1/759 (0.1%) | ||
| Haematoma | 5/743 (0.7%) | 5/759 (0.7%) | ||
| Haemodynamic instability | 2/743 (0.3%) | 0/759 (0%) | ||
| Hypertension | 61/743 (8.2%) | 68/759 (9%) | ||
| Hypotension | 182/743 (24.5%) | 185/759 (24.4%) | ||
| Hypovolaemic shock | 1/743 (0.1%) | 0/759 (0%) | ||
| Jugular vein thrombosis | 1/743 (0.1%) | 2/759 (0.3%) | ||
| Labile blood pressure | 21/743 (2.8%) | 14/759 (1.8%) | ||
| Labile hypertension | 0/743 (0%) | 1/759 (0.1%) | ||
| Lymphocele | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Orthostatic hypotension | 3/743 (0.4%) | 0/759 (0%) | ||
| Pallor | 2/743 (0.3%) | 8/759 (1.1%) | ||
| Peripheral arterial occlusive disease | 1/743 (0.1%) | 2/759 (0.3%) | ||
| Peripheral coldness | 2/743 (0.3%) | 2/759 (0.3%) | ||
| Peripheral embolism | 0/743 (0%) | 1/759 (0.1%) | ||
| Peripheral ischaemia | 1/743 (0.1%) | 2/759 (0.3%) | ||
| Peripheral vascular disorder | 1/743 (0.1%) | 0/759 (0%) | ||
| Phlebitis | 3/743 (0.4%) | 5/759 (0.7%) | ||
| Shock haemorrhagic | 0/743 (0%) | 1/759 (0.1%) | ||
| Subclavian artery stenosis | 1/743 (0.1%) | 0/759 (0%) | ||
| Subclavian vein thrombosis | 0/743 (0%) | 1/759 (0.1%) | ||
| Thrombophlebitis superficial | 3/743 (0.4%) | 2/759 (0.3%) | ||
| Thrombosis | 1/743 (0.1%) | 1/759 (0.1%) | ||
| Vasospasm | 0/743 (0%) | 1/759 (0.1%) | ||
| Venous insufficiency | 0/743 (0%) | 1/759 (0.1%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Charlene A. Tucker, MS Executive Director, Medical Writing and Document Management |
|---|---|
| Organization | Innocoll |
| Phone | 484-406-5211 |
| ctucker@innocoll.com |
Responsible Party:
Innocoll
ClinicalTrials.gov Identifier:
NCT00600483
Other Study ID Numbers:
- INN-SWI-001
First Posted:
Jan 25, 2008
Last Update Posted:
May 5, 2022
Last Verified:
May 1, 2022