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| ID | Type | Description | Link |
|---|---|---|---|
| 2005_085 |
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Comparison of the safety and effectiveness of standard drug dosing versus a daily dose 3 times higher than the standard dose in patients with invasive candidiasis (bloodstream and/or systemic yeast infections)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | 50 mg intravenous (IV) infusion (diluted with 9% saline) administered daily (following a 70-mg IV loading dose on Day 1), over the course of ~2 hrs. all patients should be treated with antifungal therapy for at least 14 days following both the improvement in clinical and radiographic signs of disease and the eradication of Candida from culture samples obtained from the invasive site of infection. |
|
| 2 | Experimental | 150 mg intravenous (IV) infusion (diluted with 9% saline) administered daily, over the course of ~2 hrs. all patients should be treated with antifungal therapy for at least 14 days following both the improvement in clinical and radiographic signs of disease and the eradication of Candida from culture samples obtained from the invasive site of infection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| caspofungin acetate | Drug | Caspofungin acetate 50 mg IV infusion (diluted with 9% saline) (following a 70-mg IV loading dose on Day 1); Caspofungin acetate 150 mg IV infusion (diluted with 9% saline) administered daily, over the course of ~2 hrs. Duration of Treatment - 14-90 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Who Develop Significant Drug-related Adverse Events. | Number of patients with at least 1 significant drug-related adverse event (serious drug-related or drug-related adverse events leading to caspofungin discontinuation) while on caspofungin study therapy or during the immediate 14-day post-caspofungin therapy period. | 90 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With a Favorable Overall Response. | Number of patients with a favorable overall response, defined as a clinical response of "cure" or "apparent cure" along with a microbiological response of "eradication" or "presumptive eradication" at the End of Caspofungin Therapy. | 90 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19419331 | Background | Betts RF, Nucci M, Talwar D, Gareca M, Queiroz-Telles F, Bedimo RJ, Herbrecht R, Ruiz-Palacios G, Young JA, Baddley JW, Strohmaier KM, Tucker KA, Taylor AF, Kartsonis NA; Caspofungin High-Dose Study Group. A Multicenter, double-blind trial of a high-dose caspofungin treatment regimen versus a standard caspofungin treatment regimen for adult patients with invasive candidiasis. Clin Infect Dis. 2009 Jun 15;48(12):1676-84. doi: 10.1086/598933. |
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This was a Phase III study. The first patient was enrolled (FPE) on 13-Jan-2006. The last patient's last visit (LPLV) was on 13-Mar-2008. A total of 38 inpatient centers were involved in the recruitment worldwide (14 in the United States, 13 in the European Union, 7 in Central or South America, and 4 in Asia)
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| ID | Title | Description |
|---|---|---|
| FG000 | Caspofungin 70/50 mg | Caspofungin 50 mg IV daily (following a 70-mg IV loading dose on Day 1) |
| FG001 | Caspofungin 150 mg | Caspofungin 150 mg IV daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Caspofungin 70/50 mg | Caspofungin 50 mg IV daily (following a 70-mg IV loading dose on Day 1) |
| BG001 | Caspofungin 150 mg | Caspofungin 150 mg IV daily |
| 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, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Site Of Invasive Candida Infection | This table lists the site of invasive candidiasis. Patients are included in only 1 category. Patients with more than 1 site of infection are counted under "Acute disseminated candidiasis or multiple sites". | Number | Participants |
| |||||||||||||||
| APACHE II Score (at Study Entry) | APACHE (Acute Physiology and Chronic Health Evaluation) is a system of classifying severity of illnesses in intensive care patients. The possible range of values is 0 (minimum severity) to 71 (maximum severity). | Mean | Full Range | Units on a Scale |
|
| 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 Patients Who Develop Significant Drug-related Adverse Events. | Number of patients with at least 1 significant drug-related adverse event (serious drug-related or drug-related adverse events leading to caspofungin discontinuation) while on caspofungin study therapy or during the immediate 14-day post-caspofungin therapy period. | All patients as treated population | Posted | Number | Participants | 90 Days |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With a Favorable Overall Response. | Number of patients with a favorable overall response, defined as a clinical response of "cure" or "apparent cure" along with a microbiological response of "eradication" or "presumptive eradication" at the End of Caspofungin Therapy. | Full Analysis Set (FAS): Included those patients who received at least 1 full dose of caspofungin study therapy and had a documented diagnosis of invasive candidiasis from a sterile, invasive body site, as defined in the protocol. | Posted | Number | Participants | 90 Days |
|
|
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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 | Caspofungin 70/50 mg | Caspofungin 50 mg IV daily (following a 70-mg IV loading dose on Day 1) | 46 | 69 | ||||
| EG001 | Caspofungin 150 mg | Caspofungin 150 mg IV daily | 44 | 70 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Acute Myocardial Infarction | Cardiac disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Atrioventricular Block | Cardiac disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Atrioventricular Block Complete | Cardiac disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Cardiac Arrest | Cardiac disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Cardio-Respiratory Arrest | Cardiac disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Electromechanical Disorder | Cardiac disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Gastrointestinal Ulcer Perforation | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Intra-Abdominal Haemorrhage | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Lower Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Peritoneal Haemorrhage | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Brain Death | General disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| General Physical Health Deterioration | General disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Multi-Organ Failure | General disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Systemic Inflammatory Response Syndrome | General disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Hepatitis Toxic | Hepatobiliary disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Jaundice Cholestatic | Hepatobiliary disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Abdominal Sepsis | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
| |
| Cholecystitis Infective | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
| |
| Clostridial Infection | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
| |
| Enterococcal Bacteraemia | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
| |
| Fungaemia | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
| |
| Fungal Sepsis | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
| |
| Klebsiella Bacteraemia | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
| |
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
| |
| Meningitis Aseptic | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
| |
| Pneumonia Staphylococcal | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
| |
| Pseudomonal Bacteraemia | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
| |
| Stenotrophomonas Infection | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
| |
| Systemic Candida | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
| |
| Wound Infection | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
| |
| Accidental Overdose | Injury, poisoning and procedural complications | MedDRA 10.1 | Non-systematic Assessment |
| |
| Tracheal Obstruction | Injury, poisoning and procedural complications | MedDRA 10.1 | Non-systematic Assessment |
| |
| Joint Swelling | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Non-systematic Assessment |
| |
| Chronic Myeloid Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Non-systematic Assessment |
| |
| Colon Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Non-systematic Assessment |
| |
| Metastases To Lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Non-systematic Assessment |
| |
| Pituitary Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Non-systematic Assessment |
| |
| Tumour Necrosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Non-systematic Assessment |
| |
| Cerebral Haematoma | Nervous system disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Myasthenia Gravis | Nervous system disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Partial Seizures | Nervous system disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Oliguria | Renal and urinary disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Renal Failure Acute | Renal and urinary disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Acute Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Acute Respiratory Distress Syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Hypercapnia | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Lung Infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Pneumonia Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Respiratory Arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Respiratory Disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Haemodynamic Instability | Vascular disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Peripheral Vascular Disorder | Vascular disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Shock Haemorrhage | Vascular disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Venous Thrombosis Limb | Vascular disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Ventricular Tachycardia | Cardiac disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Adrenal Insufficiency | Endocrine disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Gastrointestinal Hemorrhage | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Generalised Oedema | General disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Hypothermia | General disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Injection Site Erythema | General disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Injection Site Phlebitis | General disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Injection Site Swelling | General disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
| |
| Staphylococcal Bacteraemia | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
| |
| Activated Partial Thromboplastin Time Prolonged | Investigations | MedDRA 10.1 | Non-systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA 10.1 | Non-systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA 10.1 | Non-systematic Assessment |
| |
| Blood Albumin Decreased | Investigations | MedDRA 10.1 | Non-systematic Assessment |
| |
| Blood Alkaline Phosphatase Increased | Investigations | MedDRA 10.1 | Non-systematic Assessment |
| |
| Blood Bilirubin Increased | Investigations | MedDRA 10.1 | Non-systematic Assessment |
| |
| Blood Calcium Decreased | Investigations | MedDRA 10.1 | Non-systematic Assessment |
| |
| Blood Calcium Increased | Investigations | MedDRA 10.1 | Non-systematic Assessment |
| |
| Blood Chloride Increased | Investigations | MedDRA 10.1 | Non-systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA 10.1 | Non-systematic Assessment |
| |
| Blood Glucose Decreased | Investigations | MedDRA 10.1 | Non-systematic Assessment |
| |
| Blood Glucose Increased | Investigations | MedDRA 10.1 | Non-systematic Assessment |
| |
| Blood Magnesium Decreased | Investigations | MedDRA 10.1 | Non-systematic Assessment |
| |
| Blood Phosphorus Decreased | Investigations | MedDRA 10.1 | Non-systematic Assessment |
| |
| Blood Potassium Decreased | Investigations | MedDRA 10.1 | Non-systematic Assessment |
| |
| Blood Potassium Increased | Investigations | MedDRA 10.1 | Non-systematic Assessment |
| |
| Blood Sodium Decreased | Investigations | MedDRA 10.1 | Non-systematic Assessment |
| |
| Blood Sodium Increased | Investigations | MedDRA 10.1 | Non-systematic Assessment |
| |
| Blood Urea Increased | Investigations | MedDRA 10.1 | Non-systematic Assessment |
| |
| Blood Uric Acid Decreased | Investigations | MedDRA 10.1 | Non-systematic Assessment |
| |
| Carbon Dioxide Decreased | Investigations | MedDRA 10.1 | Non-systematic Assessment |
| |
| White Blood Cell Count Increased | Investigations | MedDRA 10.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Investigations | MedDRA 10.1 | Non-systematic Assessment |
| |
| Hypoglycaemia | Investigations | MedDRA 10.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Investigations | MedDRA 10.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Confusional State | Psychiatric disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Renal Failure Acute | Renal and urinary disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Vaginal Discharge | Reproductive system and breast disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Lung Infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Decubitus Ulcer | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Jugular Vein Thrombosis | Vascular disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Venous Thrombosis Limb | Vascular disorders | MedDRA 10.1 | Non-systematic Assessment |
|
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D058365 | Candidiasis, Invasive |
| ID | Term |
|---|---|
| D002177 | Candidiasis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000072742 | Invasive Fungal Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077336 | Caspofungin |
| ID | Term |
|---|---|
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D054714 | Echinocandins |
| D010456 | Peptides, Cyclic |
Not provided
Not provided
| Male |
|
| Black |
|
| Asian |
|
| Hispanic |
|
| Other |
|
| Abscess (involving a non-abdominal site) |
|
| Acute disseminated candidiasis or multiple sites |
|
| Blood (candidemia) |
|
| Chronic disseminated candidiasis (hepatosplenic) |
|
| Fungemia (non Candida) |
|
| Kidney (Pyelonephritis) |
|
| Lung (Pneumonia) |
|
| Peritoneal fluid (Peritonitis) |
|
| Pleural fluid (Empyema) |
|
|
|