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| ID | Type | Description | Link |
|---|---|---|---|
| R44DK055891-06 | U.S. NIH Grant/Contract | View source |
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Business Reasons
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The primary objective of this pilot study is to demonstrate the feasibility of recruiting eligible patients for the purposes of assessing the temporal aspects and rates of Catheter Associated Urinary Tract Infection (CAUTI), based on the agreed-upon case definition so that the numbers needed for a pivotal study can be better estimated.
This pilot study will be a prospective, single site, randomized clinical investigation comparing the safety and effectiveness of the ICET TIC antimicrobial Foley catheter, against the infection control standard-of-care, the BARD ® LUBRI-SIL® I.C. Foley catheter.
Approximately 160 patients will be screened. The study has been designed to enroll approximately 120 eligible subjects to obtain about 60 evaluable subjects (30 in each arm). Subjects who meet the eligibility criteria will be enrolled into the study and randomly assigned to the experimental or standard-of-care group in a 1:1 ratio.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICETâ„¢ TIC Foley Catheter | Experimental | Route of Administration: Urinary Bladder Catheterization |
|
| BARD® LUBRI-SIL® IC Foley Catheter | Active Comparator | Route of Administration: Urinary Bladder Catheterization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICETâ„¢ TIC Foley Catheter | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Affected, During Treatment and Follow-up Time Periods, by a Catheter Associated Urinary Tract Infection (CAUTI) Event After First CAUTI Event. | 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. | up to 30th day from the time of catheterization |
| The Proportion of Subjects With at Least One CAUTI | CAUTI 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 | 48 ± 24 hours or more |
| Measure | Description | Time Frame |
|---|---|---|
| The Proportion of Subjects With Symptomatic Urinary Tract Infection (SUTI) | Patients 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Organism Relation to CAUTI and TIC | Organisms found in relation to CAUTI events in TIC versus control. | up to 30th day from the time of catheterization |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan E Kline, MD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota Fairview medical center | Minneapolis | Minnesota | 55455 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25728152 | Derived | Leuck AM, Johnson JR, Hunt MA, Dhody K, Kazempour K, Ferrieri P, Kline S. Safety and efficacy of a novel silver-impregnated urinary catheter system for preventing catheter-associated bacteriuria: a pilot randomized clinical trial. Am J Infect Control. 2015 Mar 1;43(3):260-5. doi: 10.1016/j.ajic.2014.11.021. |
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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
Single Site Recruitment
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
|
| BARD® LUBRI-SIL® IC Foley Catheter | Device | The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®* silver alloy coating and BARD® hydrogel. |
|
|
| up to 30th day from the time of catheterization |
| The Proportion of Subjects With Asymptomatic Bacteremic Urinary Tract Infection (ABUTI) | Patients 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. | up to 30th day from the time of catheterization |
| ICETâ„¢ TIC Foley Catheter |
Route of Administration: Urinary Bladder Catheterization ICETâ„¢ 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. |
| Intent to Treat (ITT) Population |
|
| Evaluable Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Overall Number of Baseline Participants (95 participants) includes 4 individuals who were randomized, but not treated.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | ICETâ„¢ TIC Foley Catheter | Route of Administration: Urinary Bladder Catheterization ICETâ„¢ 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Prior to Study Termination; of 95 subjects randomized, 91 subjects were treated and therefore considered as part of Baseline Gender demographics. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects Affected, During Treatment and Follow-up Time Periods, by a Catheter Associated Urinary Tract Infection (CAUTI) Event After First CAUTI Event. | 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. | Posted | Number | participants | up to 30th day from the time of catheterization |
|
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | The Proportion of Subjects With Symptomatic Urinary Tract Infection (SUTI) | Patients 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 | Posted | Number | Participants | up to 30th day from the time of catheterization |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | The Proportion of Subjects With Asymptomatic Bacteremic Urinary Tract Infection (ABUTI) | Patients 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. | Posted | Number | participants | up to 30th day from the time of catheterization |
| |||||||||||||||||||||||||||||||||||||||
| Primary | The Proportion of Subjects With at Least One CAUTI | CAUTI 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 | Posted | Number | participants | 48 ± 24 hours or more |
| |||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Organism Relation to CAUTI and TIC | Organisms found in relation to CAUTI events in TIC versus control. | Posted | Number | participants | up to 30th day from the time of catheterization |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 3 | 45 | 39 | 45 | ||
| EG001 | ICETâ„¢ TIC Foley Catheter | Route of Administration: Urinary Bladder Catheterization ICETâ„¢ 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. | 0 | 46 | 40 | 46 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Myocardial iscaemia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Extradural haematoma | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Thalamic infarction | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 15 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Deafness unilateral | Ear and labyrinth disorders | MedDRA 15 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 15 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 15 | Systematic Assessment |
| |
| Eye swelling | Eye disorders | MedDRA 15 | Systematic Assessment |
| |
| Eyelid ptosis | Eye disorders | MedDRA 15 | Systematic Assessment |
| |
| Gaze palsy | Eye disorders | MedDRA 15 | Systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA 15 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 15 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Gastric Haemorrhage | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Tongue haematoma | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA 15 | Systematic Assessment |
| |
| Infusion site extrvasation | General disorders | MedDRA 15 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 15 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 15 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 15 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15 | Systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA 15 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 15 | Systematic Assessment |
| |
| Incision site erythema | Injury, poisoning and procedural complications | MedDRA 15 | Systematic Assessment |
| |
| Incision site oedema | Injury, poisoning and procedural complications | MedDRA 15 | Systematic Assessment |
| |
| Incision site pain | Injury, poisoning and procedural complications | MedDRA 15 | Systematic Assessment |
| |
| Procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 15 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 15 | Systematic Assessment |
| |
| Blood phosphorus increased | Investigations | MedDRA 15 | Systematic Assessment |
| |
| Breath sounds abnormal | Investigations | MedDRA 15 | Systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA 15 | Systematic Assessment |
| |
| Urine output decreased | Investigations | MedDRA 15 | Systematic Assessment |
| |
| Urine output increased | Investigations | MedDRA 15 | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA 15 | Systematic Assessment |
| |
| Fluid retention | Metabolism and nutrition disorders | MedDRA 15 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 15 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 15 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 15 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15 | Systematic Assessment |
| |
| Facial asymmetry | Musculoskeletal and connective tissue disorders | MedDRA 15 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 15 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 15 | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| Brudzinski's sign | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| Clonus | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| Facial paresis | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| Hemianopia homonymous | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| IIIrd nerve paralysis | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| Intracranial hypotension | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| Monoplegia | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| Nystagmus | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| Petit mal epilepsy | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| Pneumocephalus | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| Restless legs syndrome | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| VIIth nerve paralysis | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 15 | Systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA 15 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 15 | Systematic Assessment |
| |
| Oliguria | Renal and urinary disorders | MedDRA 15 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 15 | Systematic Assessment |
| |
| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Bradypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 15 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 15 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 15 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15 | Systematic Assessment |
| |
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 15 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 15 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 15 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 15 | Systematic Assessment |
| |
| Syncope | Vascular disorders | MedDRA 15 | Systematic Assessment |
|
Study could not be completed for business reasons.
Not provided
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shantha Sarangapani | ICET, Inc. | 781-769-6064 | Shantha@icetinc.com |
| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Number of Subjects Not Receiving Treatment |
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