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The purpose of this postmarketing surveillance study is to collect an extensive body of data in a large patient population in every day life to investigate the safety and efficacy of NOXAFIL® (posaconazole) in the treatment of invasive fungal disease.
Data regarding demographics, underlying disease, prior fungal infection, prior antifungal medication, invasive fungal infection signs & symptoms, concomitant medication, posaconazole use, tolerability, safety and therapy outcome will be collected on abstracted electronic Case Report Forms.
This surveillance study was originally limited to subjects receiving posaconazole as salvage antifungal therapy as indicated. A subgroup of subjects at risk for invasive fungal infection was included for prophylactic treatment following the enlargement of the marketing authorization for NOXAFIL® (posaconazole) during the course of the study. These participants only contributed data for the assessment of safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Posaconazole (assigned by physician in normal practice) |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Posaconazole | Drug | The usual dose of NOXAFIL® is 400 mg twice daily (10 mL) at meals or with 240 mL of a food supplement. For patients unable to take meals or food supplements, NOXAFIL® is administered at a dose of 200 mg (5 mL) four times daily. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Adverse Drug Reactions. | The severity of an Adverse Drug Reaction is determined on the basis of the following definitions: Mild: The abnormality, symptom or event is noticed but well tolerated. Moderate: Symptoms impair normal activities and may require intervention. Severe: Clinical status is significantly impaired, normal activity is no longer possible, intervention is required. | Before starting treatment with posaconazole, during treatment, and until 100 days after treatment. |
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Inclusion Criteria:
Adult subjects with:
Exclusion Criteria:
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Subjects with invasive fungal infection refractory to first-line treatment or unable to tolerate it were selected at hospitals in Germany.
Following the enlargement of the marketing authorization for posaconazole, subjects at risk for invasive fungal infection were also enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Posaconazole (Assigned by Physician in Normal Practice) |
|
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Posaconazole (Assigned by Physician in Normal Practice) |
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Participants Reporting Adverse Drug Reactions. | The severity of an Adverse Drug Reaction is determined on the basis of the following definitions: Mild: The abnormality, symptom or event is noticed but well tolerated. Moderate: Symptoms impair normal activities and may require intervention. Severe: Clinical status is significantly impaired, normal activity is no longer possible, intervention is required. | Posted | Number | Participants | Before starting treatment with posaconazole, during treatment, and until 100 days after treatment. |
|
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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 | Posaconazole (Assigned by Physician in Normal Practice) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| THROMBOTIC THROMBOCYTOPENIC PURPURA | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C101425 | posaconazole |
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|
| Other |
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| Missing |
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| Other |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 33 |
| 214 |
| 49 |
| 214 |
| ATRIOVENTRICULAR BLOCK COMPLETE | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
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| CYSTIC LYMPHANGIOMA | Congenital, familial and genetic disorders | MedDRA 11.1 | Systematic Assessment |
|
| VISUAL ACUITY REDUCED | Eye disorders | MedDRA 11.1 | Systematic Assessment |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| SMALL INTESTINAL PERFORATION | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| CHEST PAIN | General disorders | MedDRA 11.1 | Systematic Assessment |
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| DEATH | General disorders | MedDRA 11.1 | Systematic Assessment |
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| DISEASE PROGRESSION | General disorders | MedDRA 11.1 | Systematic Assessment |
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| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA 11.1 | Systematic Assessment |
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| INJECTION SITE THROMBOSIS | General disorders | MedDRA 11.1 | Systematic Assessment |
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| MULTI-ORGAN FAILURE | General disorders | MedDRA 11.1 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA 11.1 | Systematic Assessment |
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| CHOLANGITIS | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
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| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
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| HEPATOTOXICITY | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
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| ACUTE GRAFT VERSUS HOST DISEASE | Immune system disorders | MedDRA 11.1 | Systematic Assessment |
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| ACUTE GRAFT VERSUS HOST DISEASE IN INTESTINE | Immune system disorders | MedDRA 11.1 | Systematic Assessment |
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| ACUTE GRAFT VERSUS HOST DISEASE IN LIVER | Immune system disorders | MedDRA 11.1 | Systematic Assessment |
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| ANAPHYLACTIC REACTION | Immune system disorders | MedDRA 11.1 | Systematic Assessment |
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| ABSCESS LIMB | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| ABSCESS SWEAT GLAND | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| BRONCHOPNEUMONIA | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| CYTOMEGALOVIRUS INFECTION | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| ENTEROCOCCAL SEPSIS | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| ESCHERICHIA SEPSIS | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| INFECTION | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| KLEBSIELLA SEPSIS | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| OTITIS MEDIA BACTERIAL | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| PNEUMONIA | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| PSEUDOMONAL SEPSIS | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| SEPSIS | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| SEPTIC SHOCK | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| SKIN INFECTION | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| STAPHYLOCOCCAL SEPSIS | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| STREPTOCOCCAL SEPSIS | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| UROSEPSIS | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| SPLENIC RUPTURE | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
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| SUBDURAL HAEMATOMA | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
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| TRANSFUSION REACTION | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
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| BLOOD CREATININE INCREASED | Investigations | MedDRA 11.1 | Systematic Assessment |
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| BLOOD CULTURE POSITIVE | Investigations | MedDRA 11.1 | Systematic Assessment |
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| C-REACTIVE PROTEIN INCREASED | Investigations | MedDRA 11.1 | Systematic Assessment |
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| HAEMOGLOBIN DECREASED | Investigations | MedDRA 11.1 | Systematic Assessment |
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| HEPATIC ENZYME INCREASED | Investigations | MedDRA 11.1 | Systematic Assessment |
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| RENAL FUNCTION TEST ABNORMAL | Investigations | MedDRA 11.1 | Systematic Assessment |
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| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| FACET JOINT SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| MYOPATHY | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| LUNG ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
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| LYMPHOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| PROSTATIC ADENOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| CRITICAL ILLNESS POLYNEUROPATHY | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
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| ENCEPHALITIS | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
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| TOXIC NEUROPATHY | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
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| TRANSIENT PSYCHOSIS | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
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| ACUTE PRERENAL FAILURE | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
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| RENAL FAILURE | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
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| RENAL FAILURE ACUTE | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
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| LUNG INFILTRATION | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
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| PULMONARY HAEMORRHAGE | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
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| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
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| SUBCLAVIAN VEIN THROMBOSIS | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
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| THROMBOSIS | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| C-REACTIVE PROTEIN INCREASED | Investigations | MedDRA 11.1 | Systematic Assessment |
|
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