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Serious infections caused by resistant bacteria are becoming more of a medical problem throughout the world. This study will measure how well TD-6424 (Telavancin) can control infections and whether the drug is safe to give to patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telavancin | Experimental |
| |
| Standard of care for cSSSI | Active Comparator | cSSSI - comlicated skin and skin structure infections |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telavancin | Drug | Telavancin 7.5 mg/kg/day, amended to 10 mg/kg/day, IV (intravenously) for up to 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response Which is Measured at Test of Cure (TOC) in the Clinically Evaluable (CE) Population |
| 7 to 14 days following completion of antibiotic treatment |
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Inclusion Criteria:
Patients must have a diagnosis of one of the following complicated skin and soft tissue infections and either a suspected or confirmed Gram positive organism
Patients must be expected to require at least 4 days of intravenous (IV) antibiotic treatment
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| G. Ralph Corey, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paradise Valley Hospital, 2400 E. 4th Street | National City | California | 91950 | United States |
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Enrollment Period: 20Feb2004 to 09SEP2004
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| ID | Title | Description |
|---|---|---|
| FG000 | Telavancin | Telavancin 10 mg/kg every 24 hours intravenously |
| FG001 | Standard of Care for cSSSI | Standard therapy [nafcillin or oxacillin 2 gram, or cloxacillin (in S. Africa) 0.5 to 1.0 gram, every 6 hours, or vancomycin 1 gram every 12 hours, intravenously] |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| vancomycin or antistaphylococcal penicillin | Drug | Vancomycin 1 Gram IV (intravenously) every 12 hrs or nafcillin 2 Grams, oxacillin 2 Grams, or (in South Africa) cloxacillin 0.5 - 1 Gram, IV (intravenously) every 6 hrs for up to 14 days. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Telavancin | Telavancin 10 mg/kg every 24 hours intravenously |
| BG001 | Standard of Care for cSSSI | Standard therapy [nafcillin or oxacillin 2 gram, or cloxacillin (in S. Africa) 0.5 to 1.0 gram, every 6 hours, or vancomycin 1 gram every 12 hours, intravenously] |
| 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 | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Diabetes Status | Number | participants |
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| 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 | Clinical Response Which is Measured at Test of Cure (TOC) in the Clinically Evaluable (CE) Population |
| The CE population was a subset of the All Treated Population and was composed of patients who met the inclusion/exclusion criteria or were granted permission to enroll and had a clinical response of "cure" or "failure." The All Treated Population patients received at least one treatment. The Primary Efficacy Analysis was of the CE population. | Posted | Number | participants | 7 to 14 days following completion of antibiotic treatment |
|
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The Safety Population was the "All Treated Population" - all patients who received one treatment. The Primary Analysis was of the Clinically Evaluable (CE) Population. The CE population was composed of the patients who met the inclusion / exclusion criteria or were granted permission to enroll and had a clinical response of "cure" or "failure".
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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 | Telavancin | Telavancin 10 mg/kg every 24 hours intravenously | 7 | 100 | 56 | 100 | ||
| EG001 | Standard of Care for cSSSI | Standard therapy [nafcillin or oxacillin 2 gram, or cloxacillin (in S. Africa) 0.5 to 1.0 gram, every 6 hours, or vancomycin 1 gram every 12 hours, intravenously] | 3 | 95 | 54 | 95 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Renal Failure Acute | Renal and urinary disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Disseminated Intravascular Coagulation | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Ileostomy | Surgical and medical procedures | Systematic Assessment |
| ||
| Lobar Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Myositis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Subcutaneous Abscess | Infections and infestations | Systematic Assessment |
| ||
| Suicidal Ideation | Psychiatric disorders | Systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Wound Haemorrhage | Vascular disorders | Systematic Assessment |
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| Wound Infection | Infections and infestations | Systematic Assessment |
| ||
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Bacteraemia | Infections and infestations | Systematic Assessment |
| ||
| Hepatic Failure | Hepatobiliary disorders | Systematic Assessment |
| ||
| Lung Infiltration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Multi-organ Failure | General disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Disseminated Intravascular Coagulation | Blood and lymphatic system disorders | Systematic Assessment |
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| Leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Pancytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Thrombocythaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac failure | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac failure congestive | Cardiac disorders | Systematic Assessment |
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| Cyanosis | Cardiac disorders | Systematic Assessment |
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| Palpitations | Cardiac disorders | Systematic Assessment |
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| Sinus bradycardia | Cardiac disorders | Systematic Assessment |
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| Tachycardia | Cardiac disorders | Systematic Assessment |
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| Hyperthyroidism | Endocrine disorders | Systematic Assessment |
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| Eye Irritation | Eye disorders | Systematic Assessment |
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| Eye Swelling | Eye disorders | Systematic Assessment |
| ||
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dry Mouth | Gastrointestinal disorders | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Haemorrhoids | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hiatus Hernia | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Oesophagitis | Gastrointestinal disorders | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Application Site Erythema | General disorders | Non-systematic Assessment |
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| Application Site Pruritus | General disorders | Non-systematic Assessment |
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| Catheter Site Inflammation | General disorders | Non-systematic Assessment |
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| Chest Pain | General disorders | Systematic Assessment |
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| Chills | General disorders | Systematic Assessment |
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| Drug Withdrawal Syndrome | General disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Infusion site bruising | General disorders | Non-systematic Assessment |
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| Infusion site burning | General disorders | Non-systematic Assessment |
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| Infusion site erythema | General disorders | Non-systematic Assessment |
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| Infusion site induration | General disorders | Non-systematic Assessment |
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| Infusion site pain | General disorders | Non-systematic Assessment |
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| Infusion site phlebitis | General disorders | Non-systematic Assessment |
| ||
| Infusion site rash | General disorders | Non-systematic Assessment |
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| Infusion site swelling | General disorders | Non-systematic Assessment |
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| Multi-organ Failure | General disorders | Systematic Assessment |
| ||
| Night sweats | General disorders | Systematic Assessment |
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| Oedema Peripheral | General disorders | Systematic Assessment |
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| Pyrexia | General disorders | Systematic Assessment |
| ||
| Hepatic Failure | Hepatobiliary disorders | Systematic Assessment |
| ||
| Abscess | Infections and infestations | Systematic Assessment |
| ||
| Acarodermatitis | Infections and infestations | Systematic Assessment |
| ||
| Bacteraemia | Infections and infestations | Systematic Assessment |
| ||
| Candidiasis | Infections and infestations | Systematic Assessment |
| ||
| Central Line Infection | Infections and infestations | Systematic Assessment |
| ||
| Cystitis | Infections and infestations | Systematic Assessment |
| ||
| Fungal Infection | Infections and infestations | Systematic Assessment |
| ||
| Fungal skin infection | Infections and infestations | Systematic Assessment |
| ||
| Herpes Simplex | Infections and infestations | Systematic Assessment |
| ||
| Herpes Zoster | Infections and infestations | Systematic Assessment |
| ||
| HIV Infection | Infections and infestations | Systematic Assessment |
| ||
| Infection | Infections and infestations | Systematic Assessment |
| ||
| Lobar Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Oral Candidiasis | Infections and infestations | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Septic Shock | Infections and infestations | Systematic Assessment |
| ||
| Subcutaneous Abscess | Infections and infestations | Systematic Assessment |
| ||
| Tinea Infection | Infections and infestations | Systematic Assessment |
| ||
| Tuberculosis | Infections and infestations | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
| ||
| Urinary Tract Infection Fungal | Infections and infestations | Systematic Assessment |
| ||
| Vaginal mycosis | Infections and infestations | Systematic Assessment |
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| Wound Infection | Infections and infestations | Systematic Assessment |
| ||
| Limb Injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Activated Partial Thromboplastin Time | Investigations | Systematic Assessment |
| ||
| Alanine Aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Albumin Urine Present | Investigations | Systematic Assessment |
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| Aspartate Aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Bacteria Urine | Investigations | Systematic Assessment |
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| Blood Alkaline Phosphatase Increased | Investigations | Systematic Assessment |
| ||
| Blood Bilirubin Increased | Investigations | Systematic Assessment |
| ||
| Blood Creatinine Increased | Investigations | Systematic Assessment |
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| Blood Glucose increased | Investigations | Systematic Assessment |
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| Blood Lactate Dehydrogenase Increased | Investigations | Systematic Assessment |
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| Blood Magnesium decreased | Investigations | Systematic Assessment |
| ||
| Blood Urea increased | Investigations | Systematic Assessment |
| ||
| Eosinophil Count increased | Investigations | Systematic Assessment |
| ||
| Gamma-glutamyltransferase increased | Investigations | Systematic Assessment |
| ||
| Hepatic Enzyme increased | Investigations | Systematic Assessment |
| ||
| Liver function test abnormal | Investigations | Systematic Assessment |
| ||
| Nitrite Urine present | Investigations | Systematic Assessment |
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| Platelet count increased | Investigations | Systematic Assessment |
| ||
| Prothrombin time prolonged | Investigations | Systematic Assessment |
| ||
| QRS axis abnormal | Investigations | Systematic Assessment |
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| Respiratory rate increased | Investigations | Systematic Assessment |
| ||
| Urinary casts | Investigations | Systematic Assessment |
| ||
| Urine analysis abnormal | Investigations | Systematic Assessment |
| ||
| White Blood Cell Count decreased | Investigations | Systematic Assessment |
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| White Blood Cell Count increased | Investigations | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyperkalaemia | Investigations | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypomagnesaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Polydipsia | Metabolism and nutrition disorders | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Muscle Spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Musculoskeletal Discomfort | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Myositis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pain in Extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pain in Jaw | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Ageusia | Nervous system disorders | Systematic Assessment |
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| Depressed Level of Consciousness | Nervous system disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Dizziness Postural | Nervous system disorders | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | Systematic Assessment |
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| Lethargy | Nervous system disorders | Systematic Assessment |
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| Paraesthesia oral | Nervous system disorders | Systematic Assessment |
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| Tremor | Nervous system disorders | Systematic Assessment |
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| Affect Lability | Psychiatric disorders | Systematic Assessment |
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| Agitation | Psychiatric disorders | Systematic Assessment |
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| Anxiety | Psychiatric disorders | Systematic Assessment |
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| Confusional State | Psychiatric disorders | Systematic Assessment |
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| Depression | Psychiatric disorders | Systematic Assessment |
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| Hallucination | Psychiatric disorders | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
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| Suicidal Ideation | Psychiatric disorders | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | Systematic Assessment |
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| Microalbuminuria | Renal and urinary disorders | Systematic Assessment |
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| Pyuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Renal Failure | Renal and urinary disorders | Systematic Assessment |
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| Renal Failure Acute | Renal and urinary disorders | Systematic Assessment |
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| Renal Impairment | Renal and urinary disorders | Systematic Assessment |
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| Urinary Incontinence | Renal and urinary disorders | Systematic Assessment |
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| Genital Burning Sensation | Reproductive system and breast disorders | Systematic Assessment |
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| Genital Pruritis Female | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Crackles Lung | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Lung Infiltration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Wheezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Pruritis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Ileostomy | Surgical and medical procedures | Systematic Assessment |
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| Intubation | Surgical and medical procedures | Systematic Assessment |
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| Flushing | Vascular disorders | Systematic Assessment |
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| Hot Flush | Vascular disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Hypovolaemic shock | Vascular disorders | Systematic Assessment |
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| Phlebitis | Vascular disorders | Systematic Assessment |
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| Thrombophlebitis | Vascular disorders | Systematic Assessment |
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| Wound Haemorrhage | Vascular disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steve Barriere, Pharm.D., Vice President, Clinical and Medical Affairs | Theravance, Inc | 650-808-6132 | sbarriere@theravance.com |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D000038 | Abscess |
| D002056 | Burns |
| D002481 | Cellulitis |
| D014456 | Ulcer |
| D014946 | Wound Infection |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D013492 | Suppuration |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
| D012874 | Skin Diseases, Infectious |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C487637 | telavancin |
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
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| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| South Africa |
|
| Not Diabetic |
|