Trial Outcomes & Findings for A Trial for the Safety and Effectiveness of a Novel Antimicrobial-Coated Foley Catheter for Reduction of CAUTI. (NCT NCT01681511)
NCT ID: NCT01681511
Last Updated: 2014-04-28
Results Overview
All randomized subjects will be followed until (1) up to 30th day from the time of catheterization or (2) the subject withdraws or is discharged from the hospital, whichever comes first and (3) 48 hours after the catheter is removed. Evaluable population (EP) refers to all randomized subjects successfully CZD \& stayed on the CZD for ≥ 48 ± 24 hours or more without any systemic (postoperative) antibiotic for CZD/non-CZD related reasons. Subjects receiving an intercurrent course of systemic antibiotics lasting \>24 hours other than surgical prophylaxis were considered non-evaluable in all analyses of effectiveness endpoints using the EP.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
up to 30th day from the time of catheterization
Results posted on
2014-04-28
Participant Flow
Single Site Recruitment
As of Study Termination: 100 Sbj signed Informed Consent, 95 Sbj RND Definitions: Safety Pop=Any Sbj receiving treatment after RND Evaluable Pop=All RND Sbj successfully CZD ≥ 72±24 hours w/out systemic (post-op) antibiotic for CZD/non-CZD related reasons. CZD=catheterized or catheter, Pop=Population, RND=Randomized, Sbj=Subject
Participant milestones
| Measure |
BARD® LUBRI-SIL® IC Foley Catheter
Route of Administration: Urinary Bladder Catheterization
BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®\* silver alloy coating and BARD® hydrogel.
|
ICET™ TIC Foley Catheter
Route of Administration: Urinary Bladder Catheterization
ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting.
|
|---|---|---|
|
Overall Study
STARTED
|
46
|
49
|
|
Overall Study
Intent to Treat (ITT) Population
|
45
|
46
|
|
Overall Study
Evaluable Population
|
16
|
14
|
|
Overall Study
COMPLETED
|
28
|
35
|
|
Overall Study
NOT COMPLETED
|
18
|
14
|
Reasons for withdrawal
| Measure |
BARD® LUBRI-SIL® IC Foley Catheter
Route of Administration: Urinary Bladder Catheterization
BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®\* silver alloy coating and BARD® hydrogel.
|
ICET™ TIC Foley Catheter
Route of Administration: Urinary Bladder Catheterization
ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting.
|
|---|---|---|
|
Overall Study
No Treatment Received
|
1
|
3
|
|
Overall Study
Failed Inclusion/Exclusion
|
3
|
0
|
|
Overall Study
No Baseline Dips Stick & Urine Culture
|
3
|
6
|
|
Overall Study
No Daily Urine Sample Collected
|
0
|
1
|
|
Overall Study
No post-catheter sample collected
|
11
|
4
|
Baseline Characteristics
A Trial for the Safety and Effectiveness of a Novel Antimicrobial-Coated Foley Catheter for Reduction of CAUTI.
Baseline characteristics by cohort
| Measure |
BARD® LUBRI-SIL® IC Foley Catheter
n=46 Participants
Route of Administration: Urinary Bladder Catheterization
BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®\* silver alloy coating and BARD® hydrogel.
|
ICET™ TIC Foley Catheter
n=49 Participants
Route of Administration: Urinary Bladder Catheterization
ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting.
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
46 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
52.3 years
STANDARD_DEVIATION 16.6 • n=7 Participants
|
55.6 years
STANDARD_DEVIATION 15.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=5 Participants
|
49 participants
n=7 Participants
|
95 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 30th day from the time of catheterizationAll randomized subjects will be followed until (1) up to 30th day from the time of catheterization or (2) the subject withdraws or is discharged from the hospital, whichever comes first and (3) 48 hours after the catheter is removed. Evaluable population (EP) refers to all randomized subjects successfully CZD \& stayed on the CZD for ≥ 48 ± 24 hours or more without any systemic (postoperative) antibiotic for CZD/non-CZD related reasons. Subjects receiving an intercurrent course of systemic antibiotics lasting \>24 hours other than surgical prophylaxis were considered non-evaluable in all analyses of effectiveness endpoints using the EP.
Outcome measures
| Measure |
BARD® LUBRI-SIL® IC Foley Catheter
n=46 Participants
Route of Administration: Urinary Bladder Catheterization
BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®\* silver alloy coating and BARD® hydrogel.
|
ICET™ TIC Foley Catheter
n=49 Participants
Route of Administration: Urinary Bladder Catheterization
ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting.
|
|---|---|---|
|
Number of Subjects Affected, During Treatment and Follow-up Time Periods, by a Catheter Associated Urinary Tract Infection (CAUTI) Event After First CAUTI Event.
Number of Subject with Event
|
8 participants
|
3 participants
|
|
Number of Subjects Affected, During Treatment and Follow-up Time Periods, by a Catheter Associated Urinary Tract Infection (CAUTI) Event After First CAUTI Event.
Number of Subject without Event
|
37 participants
|
43 participants
|
|
Number of Subjects Affected, During Treatment and Follow-up Time Periods, by a Catheter Associated Urinary Tract Infection (CAUTI) Event After First CAUTI Event.
Number of Subjects Not Receiving Treatment
|
1 participants
|
3 participants
|
PRIMARY outcome
Timeframe: 48 ± 24 hours or moreCAUTI is as determined by blinded investigator assessment per protocol definition. DAYS TO CAUTI = (DATE OF EVENT - DATE OF CZD INSERTION) + 1. Date of event for subjects who had CAUTI is the date of urine sample collection where the CAUTI criteria are met. Date of event for subjects who did not have CAUTI is the last available urine culture collection date from samples collected during \& post CZD. p-values of time of CAUTI were obtained from log-rank test. p-values of Incidence of CAUTI were obtained from the Logistic Regression Model. Evaluable population (EP) refers to all randomized subjects successfully CZD \& stayed on the CZD for ≥ 48 ± 24 hours or more without any systemic (postoperative) antibiotic for CZD/non-CZD related reasons. Subjects receiving an intercurrent course of systemic antibiotics lasting \>24 hours other than surgical prophylaxis were considered non-evaluable in all analyses of effectiveness endpoints using the EP. CZD = Catheterized or catheter
Outcome measures
| Measure |
BARD® LUBRI-SIL® IC Foley Catheter
n=16 Participants
Route of Administration: Urinary Bladder Catheterization
BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®\* silver alloy coating and BARD® hydrogel.
|
ICET™ TIC Foley Catheter
n=14 Participants
Route of Administration: Urinary Bladder Catheterization
ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting.
|
|---|---|---|
|
The Proportion of Subjects With at Least One CAUTI
Number of Subjects With Event
|
7 participants
|
2 participants
|
|
The Proportion of Subjects With at Least One CAUTI
Number of Subjects Without Events
|
9 participants
|
12 participants
|
SECONDARY outcome
Timeframe: up to 30th day from the time of catheterizationPatients with catheter related SUTI are those having an indwelling urinary catheter in place at the time of specimen collection, or had an indwelling catheter within the previous 48 hours, and at least 1 of the following signs or symptoms with no other recognized cause: fever (\>38°C), suprapubic tenderness, or costovertebral angle pain or tenderness and a positive urinalysis demonstrated by at least one of the following findings: a. positive dipstick for leukocyte esterase and/or nitrite, b. pyuria (urine specimen collected from the catheter with ≥10 white blood cells \[WBC\]/mm3 or ≥3 WBC/high power field of unspun urine), c. microorganisms seen on Gram stain of unspun urine and a positive urine
Outcome measures
| Measure |
BARD® LUBRI-SIL® IC Foley Catheter
n=46 Participants
Route of Administration: Urinary Bladder Catheterization
BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®\* silver alloy coating and BARD® hydrogel.
|
ICET™ TIC Foley Catheter
n=49 Participants
Route of Administration: Urinary Bladder Catheterization
ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting.
|
|---|---|---|
|
The Proportion of Subjects With Symptomatic Urinary Tract Infection (SUTI)
Number of Subjects with SUTI
|
0 Participants
|
1 Participants
|
|
The Proportion of Subjects With Symptomatic Urinary Tract Infection (SUTI)
Number of Subjects without SUTI
|
45 Participants
|
45 Participants
|
|
The Proportion of Subjects With Symptomatic Urinary Tract Infection (SUTI)
Missing - Not Assessed
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: up to 30th day from the time of catheterizationPatients having an indwelling urinary catheter who have no signs or symptoms (i.e., no fever (\>38°C), no urgency, frequency, dysuria, suprapubic tenderness, or costovertebral angle pain or tenderness), and a positive urine culture from urine collected from the catheter sampling port (or a midstream voided clean catch urine in subjects being followed for 48 hours post catheter removal) of \>105 CFU/ml with no more than 2 species of uropathogen microorganisms and a positive blood culture with at least 1 matching uropathogen microorganism to the urine culture.
Outcome measures
| Measure |
BARD® LUBRI-SIL® IC Foley Catheter
n=46 Participants
Route of Administration: Urinary Bladder Catheterization
BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®\* silver alloy coating and BARD® hydrogel.
|
ICET™ TIC Foley Catheter
n=49 Participants
Route of Administration: Urinary Bladder Catheterization
ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting.
|
|---|---|---|
|
The Proportion of Subjects With Asymptomatic Bacteremic Urinary Tract Infection (ABUTI)
Number of Subjects without ABUTI
|
38 participants
|
37 participants
|
|
The Proportion of Subjects With Asymptomatic Bacteremic Urinary Tract Infection (ABUTI)
Number of Subjects with ABUTI
|
0 participants
|
0 participants
|
|
The Proportion of Subjects With Asymptomatic Bacteremic Urinary Tract Infection (ABUTI)
Missing - Not Assessed
|
8 participants
|
12 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 30th day from the time of catheterizationOrganisms found in relation to CAUTI events in TIC versus control.
Outcome measures
| Measure |
BARD® LUBRI-SIL® IC Foley Catheter
n=46 Participants
Route of Administration: Urinary Bladder Catheterization
BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®\* silver alloy coating and BARD® hydrogel.
|
ICET™ TIC Foley Catheter
n=49 Participants
Route of Administration: Urinary Bladder Catheterization
ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting.
|
|---|---|---|
|
Organism Relation to CAUTI and TIC
Candida Responsible for CAUTI Events
|
0 participants
|
1 participants
|
|
Organism Relation to CAUTI and TIC
E.Coli Responsible for CAUTI Events
|
4 participants
|
0 participants
|
|
Organism Relation to CAUTI and TIC
Klebsiella Responsible for CAUTI Events
|
1 participants
|
0 participants
|
|
Organism Relation to CAUTI and TIC
Enterococcus Responsible for CAUTI Events
|
2 participants
|
2 participants
|
|
Organism Relation to CAUTI and TIC
Pseudomonas Responsible for CAUTI Events
|
1 participants
|
0 participants
|
|
Organism Relation to CAUTI and TIC
Enterobacter Responsible for CAUTI Events
|
1 participants
|
0 participants
|
|
Organism Relation to CAUTI and TIC
CoNS Responsible for CAUTI Events
|
1 participants
|
0 participants
|
|
Organism Relation to CAUTI and TIC
Total Organisms Responsible for CAUTI Events
|
10 participants
|
3 participants
|
Adverse Events
BARD® LUBRI-SIL® IC Foley Catheter
Serious events: 3 serious events
Other events: 39 other events
Deaths: 0 deaths
ICET™ TIC Foley Catheter
Serious events: 0 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BARD® LUBRI-SIL® IC Foley Catheter
n=45 participants at risk
Route of Administration: Urinary Bladder Catheterization
BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®\* silver alloy coating and BARD® hydrogel.
|
ICET™ TIC Foley Catheter
n=46 participants at risk
Route of Administration: Urinary Bladder Catheterization
ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting.
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
2.2%
1/45 • Number of events 1
|
0.00%
0/46
|
|
Cardiac disorders
Myocardial iscaemia
|
2.2%
1/45 • Number of events 1
|
0.00%
0/46
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
2.2%
1/45 • Number of events 1
|
0.00%
0/46
|
|
Nervous system disorders
Thalamic infarction
|
2.2%
1/45 • Number of events 1
|
0.00%
0/46
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.2%
1/45 • Number of events 1
|
0.00%
0/46
|
Other adverse events
| Measure |
BARD® LUBRI-SIL® IC Foley Catheter
n=45 participants at risk
Route of Administration: Urinary Bladder Catheterization
BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®\* silver alloy coating and BARD® hydrogel.
|
ICET™ TIC Foley Catheter
n=46 participants at risk
Route of Administration: Urinary Bladder Catheterization
ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.4%
2/45 • Number of events 2
|
10.9%
5/46 • Number of events 5
|
|
Blood and lymphatic system disorders
Leukocytosis
|
6.7%
3/45 • Number of events 3
|
23.9%
11/46 • Number of events 11
|
|
Cardiac disorders
Bradycardia
|
2.2%
1/45 • Number of events 1
|
0.00%
0/46
|
|
Cardiac disorders
Atrial fibrillation
|
2.2%
1/45 • Number of events 1
|
0.00%
0/46
|
|
Cardiac disorders
Sinus bradycardia
|
4.4%
2/45 • Number of events 2
|
0.00%
0/46
|
|
Cardiac disorders
Sinus tachycardia
|
2.2%
1/45 • Number of events 1
|
4.3%
2/46 • Number of events 2
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/45
|
2.2%
1/46 • Number of events 1
|
|
Cardiac disorders
Tachycardia
|
4.4%
2/45 • Number of events 2
|
4.3%
2/46 • Number of events 2
|
|
Ear and labyrinth disorders
Deafness unilateral
|
2.2%
1/45 • Number of events 1
|
0.00%
0/46
|
|
Ear and labyrinth disorders
Vertigo
|
2.2%
1/45 • Number of events 1
|
2.2%
1/46 • Number of events 1
|
|
Eye disorders
Eye pain
|
2.2%
1/45 • Number of events 1
|
2.2%
1/46 • Number of events 1
|
|
Eye disorders
Eye swelling
|
0.00%
0/45
|
4.3%
2/46 • Number of events 2
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/45
|
2.2%
1/46 • Number of events 1
|
|
Eye disorders
Gaze palsy
|
2.2%
1/45 • Number of events 1
|
0.00%
0/46
|
|
Eye disorders
Photophobia
|
0.00%
0/45
|
2.2%
1/46 • Number of events 1
|
|
Eye disorders
Vision blurred
|
2.2%
1/45 • Number of events 1
|
0.00%
0/46
|
|
Gastrointestinal disorders
Constipation
|
4.4%
2/45 • Number of events 2
|
2.2%
1/46 • Number of events 1
|
|
Gastrointestinal disorders
Duodenal ulcer
|
2.2%
1/45 • Number of events 1
|
0.00%
0/46
|
|
Gastrointestinal disorders
Gastric Haemorrhage
|
2.2%
1/45 • Number of events 1
|
0.00%
0/46
|
|
Gastrointestinal disorders
Nausea
|
20.0%
9/45 • Number of events 9
|
13.0%
6/46 • Number of events 6
|
|
Gastrointestinal disorders
Tongue haematoma
|
2.2%
1/45 • Number of events 1
|
0.00%
0/46
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
5/45 • Number of events 5
|
8.7%
4/46 • Number of events 4
|
|
General disorders
Face oedema
|
2.2%
1/45 • Number of events 1
|
4.3%
2/46 • Number of events 2
|
|
General disorders
Infusion site extrvasation
|
0.00%
0/45
|
2.2%
1/46 • Number of events 1
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/45
|
2.2%
1/46 • Number of events 1
|
|
General disorders
Oedema
|
0.00%
0/45
|
2.2%
1/46 • Number of events 1
|
|
General disorders
Pain
|
4.4%
2/45 • Number of events 2
|
4.3%
2/46 • Number of events 2
|
|
General disorders
Pyrexia
|
8.9%
4/45 • Number of events 4
|
19.6%
9/46 • Number of events 9
|
|
Injury, poisoning and procedural complications
Excoriation
|
2.2%
1/45 • Number of events 1
|
0.00%
0/46
|
|
Injury, poisoning and procedural complications
Fall
|
2.2%
1/45 • Number of events 1
|
0.00%
0/46
|
|
Injury, poisoning and procedural complications
Incision site erythema
|
0.00%
0/45
|
2.2%
1/46 • Number of events 1
|
|
Injury, poisoning and procedural complications
Incision site oedema
|
2.2%
1/45 • Number of events 1
|
0.00%
0/46
|
|
Injury, poisoning and procedural complications
Incision site pain
|
11.1%
5/45 • Number of events 5
|
8.7%
4/46 • Number of events 4
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
2.2%
1/45 • Number of events 1
|
0.00%
0/46
|
|
Investigations
Blood glucose increased
|
6.7%
3/45 • Number of events 3
|
6.5%
3/46 • Number of events 3
|
|
Investigations
Blood phosphorus increased
|
0.00%
0/45
|
2.2%
1/46 • Number of events 1
|
|
Investigations
Breath sounds abnormal
|
4.4%
2/45 • Number of events 2
|
2.2%
1/46 • Number of events 1
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/45
|
4.3%
2/46 • Number of events 2
|
|
Investigations
Urine output decreased
|
2.2%
1/45 • Number of events 1
|
2.2%
1/46 • Number of events 1
|
|
Investigations
Urine output increased
|
2.2%
1/45 • Number of events 1
|
0.00%
0/46
|
|
Investigations
White blood cell count increased
|
2.2%
1/45 • Number of events 1
|
0.00%
0/46
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/45
|
2.2%
1/46 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.2%
1/45 • Number of events 1
|
0.00%
0/46
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/45
|
2.2%
1/46 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.2%
1/45 • Number of events 1
|
0.00%
0/46
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.2%
1/45 • Number of events 1
|
6.5%
3/46 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Facial asymmetry
|
0.00%
0/45
|
2.2%
1/46 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/45
|
2.2%
1/46 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/45
|
2.2%
1/46 • Number of events 1
|
|
Nervous system disorders
Amnesia
|
0.00%
0/45
|
2.2%
1/46 • Number of events 1
|
|
Nervous system disorders
Aphasia
|
2.2%
1/45 • Number of events 1
|
4.3%
2/46 • Number of events 2
|
|
Nervous system disorders
Balance disorder
|
2.2%
1/45 • Number of events 1
|
0.00%
0/46
|
|
Nervous system disorders
Brudzinski's sign
|
0.00%
0/45
|
2.2%
1/46 • Number of events 1
|
|
Nervous system disorders
Cerebral infarction
|
2.2%
1/45 • Number of events 1
|
0.00%
0/46
|
|
Nervous system disorders
Cerebral ischaemia
|
2.2%
1/45 • Number of events 1
|
0.00%
0/46
|
|
Nervous system disorders
Clonus
|
0.00%
0/45
|
2.2%
1/46 • Number of events 1
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/45
|
2.2%
1/46 • Number of events 1
|
|
Nervous system disorders
Facial paresis
|
0.00%
0/45
|
2.2%
1/46 • Number of events 1
|
|
Nervous system disorders
Haemorrhage intracranial
|
2.2%
1/45 • Number of events 1
|
0.00%
0/46
|
|
Nervous system disorders
Headache
|
11.1%
5/45 • Number of events 5
|
8.7%
4/46 • Number of events 4
|
|
Nervous system disorders
Hemianopia homonymous
|
0.00%
0/45
|
2.2%
1/46 • Number of events 1
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/45
|
2.2%
1/46 • Number of events 1
|
|
Nervous system disorders
IIIrd nerve paralysis
|
2.2%
1/45 • Number of events 1
|
0.00%
0/46
|
|
Nervous system disorders
Intracranial hypotension
|
0.00%
0/45
|
4.3%
2/46 • Number of events 2
|
|
Nervous system disorders
Monoplegia
|
2.2%
1/45 • Number of events 1
|
2.2%
1/46 • Number of events 1
|
|
Nervous system disorders
Nystagmus
|
6.7%
3/45 • Number of events 3
|
4.3%
2/46 • Number of events 2
|
|
Nervous system disorders
Petit mal epilepsy
|
2.2%
1/45 • Number of events 1
|
0.00%
0/46
|
|
Nervous system disorders
Pneumocephalus
|
4.4%
2/45 • Number of events 2
|
0.00%
0/46
|
|
Nervous system disorders
Restless legs syndrome
|
2.2%
1/45 • Number of events 1
|
0.00%
0/46
|
|
Nervous system disorders
Tremor
|
0.00%
0/45
|
2.2%
1/46 • Number of events 1
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.00%
0/45
|
8.7%
4/46 • Number of events 4
|
|
Psychiatric disorders
Agitation
|
2.2%
1/45 • Number of events 1
|
4.3%
2/46 • Number of events 2
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/45
|
2.2%
1/46 • Number of events 1
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/45
|
2.2%
1/46 • Number of events 1
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/45
|
4.3%
2/46 • Number of events 2
|
|
Renal and urinary disorders
Urinary retention
|
4.4%
2/45 • Number of events 2
|
8.7%
4/46 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/45
|
2.2%
1/46 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/45
|
2.2%
1/46 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bradypnoea
|
2.2%
1/45 • Number of events 1
|
0.00%
0/46
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.2%
1/45 • Number of events 1
|
2.2%
1/46 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/45
|
2.2%
1/46 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
2.2%
1/45 • Number of events 1
|
0.00%
0/46
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
2.2%
1/45 • Number of events 1
|
0.00%
0/46
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.2%
1/45 • Number of events 1
|
0.00%
0/46
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.2%
1/45 • Number of events 1
|
0.00%
0/46
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
2.2%
1/45 • Number of events 1
|
0.00%
0/46
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/45
|
2.2%
1/46 • Number of events 1
|
|
Vascular disorders
Hypertension
|
4.4%
2/45 • Number of events 2
|
0.00%
0/46
|
|
Vascular disorders
Hypotension
|
2.2%
1/45 • Number of events 1
|
0.00%
0/46
|
|
Vascular disorders
Syncope
|
2.2%
1/45 • Number of events 1
|
0.00%
0/46
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place