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This is a non-interventional study of voriconazole tablet in Korea which is mandated by the Korean government agency.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Patients who are indicated for use of voriconazole tablet. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| voriconazole tablet | Drug | 200 mg PO bid (orally, twice a day) |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Categorical Clinical Response: Cure, Improvement, Failure, or Unevaluable | Clinical response defined as: Cure=resolution of all baseline signs and symptoms of fungal infection(s); Improvement=lessening of baseline signs and symptoms or absence of one or more, but not all baseline findings; Failure=no improvement or deterioration of baseline condition; Unevaluable=incomplete therapy (efficacy could not be evaluated or discontinuation was not followed up). | Baseline (Day 1) up to 2.1 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Cultivated Strain Mycological Response: Eradication, Persistence, Superinfection, or Not Evaluable | In case cultivation performed, cultivated strain before and after Vfend administration recorded, and the improvement of mycological outcomes after administration evaluated. Mycological response defined as: Eradication=absence of signs and symptoms of fungal infection; Persistence=(no eradication) presence of fungal infection; Superinfection=existence of different strains from strains separated prior to study treatment; Not evaluable=a follow-up mycological cultivation not performed. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who are indicated for voriconazole tablet according to the drug package insert.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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There were 543 participants enrolled in this study. Of these, 230 participants were treated with the Vfend tablet formulation only, and 313 participants were treated with Vfend tablet and Vfend intravenous (IV) formulations sequentially or vice versa. These 313 participants are also included in Study A1501067 (NCT01073618).
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| ID | Title | Description |
|---|---|---|
| FG000 | Vfend | Vfend (voriconazole) tablets (recommended dose: 200mg orally every 12hours) or sequential Vfend tablet and IV Vfend (recommended dose: 6mg/kg IV infusion every 12hours for first 24hours [loading dose], 3 to 4mg/kg IV infusion every 12hours [maintenance dose]) treatment (or vice versa) for use as indicated according to approved local product document and adjusted according to medical and therapeutic necessity. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vfend | Vfend (voriconazole) tablets (recommended dose: 200mg orally every 12hours) or sequential Vfend tablet and IV Vfend (recommended dose: 6mg/kg IV infusion every 12hours for first 24hours [loading dose], 3 to 4mg/kg IV infusion every 12hours [maintenance dose]) treatment (or vice versa) for use as indicated according to approved local product document and adjusted according to medical and therapeutic necessity. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Percentage of Participants With Categorical Clinical Response: Cure, Improvement, Failure, or Unevaluable | Clinical response defined as: Cure=resolution of all baseline signs and symptoms of fungal infection(s); Improvement=lessening of baseline signs and symptoms or absence of one or more, but not all baseline findings; Failure=no improvement or deterioration of baseline condition; Unevaluable=incomplete therapy (efficacy could not be evaluated or discontinuation was not followed up). | Safety population: participants received at least 1 dose of study drug for approved indication (= Intent to treat [ITT] population plus all unevaluable participants); ITT=participants received study drug for the approved indication and had been evaluated for related paramenters at least once. | Posted | Number | Percentage of participants | Baseline (Day 1) up to 2.1 Years |
|
Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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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 | Vfend | Vfend (voriconazole) tablets (recommended dose: 200mg orally every 12hours) or sequential Vfend tablet and IV Vfend (recommended dose: 6mg/kg IV infusion every 12hours for first 24hours [loading dose], 3 to 4mg/kg IV infusion every 12hours [maintenance dose]) treatment (or vice versa) for use as indicated according to approved local product document and adjusted according to medical and therapeutic necessity. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D000072742 | Invasive Fungal Infections |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D065819 | Voriconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Baseline (Day 1) up to 2.1 Years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Vfend (voriconazole) tablets (recommended dose: 200mg orally every 12hours) or sequential Vfend tablet and IV Vfend (recommended dose: 6mg/kg IV infusion every 12hours for first 24hours [loading dose], 3 to 4mg/kg IV infusion every 12hours [maintenance dose]) treatment (or vice versa) for use as indicated according to approved local product document and adjusted according to medical and therapeutic necessity.
|
|
|
| Secondary | Percentage of Participants With Cultivated Strain Mycological Response: Eradication, Persistence, Superinfection, or Not Evaluable | In case cultivation performed, cultivated strain before and after Vfend administration recorded, and the improvement of mycological outcomes after administration evaluated. Mycological response defined as: Eradication=absence of signs and symptoms of fungal infection; Persistence=(no eradication) presence of fungal infection; Superinfection=existence of different strains from strains separated prior to study treatment; Not evaluable=a follow-up mycological cultivation not performed. | ITT; N=number of participants evaluated for mycological response. | Posted | Number | Percentage of participants | Baseline (Day 1) up to 2.1 Years |
|
|
|
| 119 |
| 543 |
| 154 |
| 543 |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Thrombotic microangiopathy | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
|
| Cardiopulmonary failure | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
|
| Left ventricular dysfunction | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
|
| Tracheo-oesophageal fistula | Congenital, familial and genetic disorders | MedDRA 13.1 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Gastric perforation | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Neutropenic colitis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Death | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Disease progression | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hepatitis | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Acute graft versus host disease in intestine | Immune system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Acute graft versus host disease in skin | Immune system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Anal abscess | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Aspergillosis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Cytomegalovirus infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Enterococcal infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Liver abscess | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Pneumonia staphylococcal | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Pseudomembranous colitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Cytomegalovirus test positive | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Oxygen saturation decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
|
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
|
| Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
|
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
|
| Cerebellar infarction | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Grand mal convulsion | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Intracranial pressure increased | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Mental impairment | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Completed suicide | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| Azotaemia | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Cystitis haemorrhagic | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| Shock | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| Euthyroid sick syndrome | Endocrine disorders | MedDRA 13.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Erosive oesophagitis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hepatitis acute | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hepatotoxicity | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Central nervous system infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Citrobacter sepsis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Cytomegalovirus chorioretinitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Pneumonia fungal | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Chemical peritonitis | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Acoustic stimulation tests | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Nephropathy toxic | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Renal failure chronic | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
|
| Left ventricular dysfunction | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
|
| Otorrhoea | Ear and labyrinth disorders | MedDRA 13.1 | Systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | MedDRA 13.1 | Systematic Assessment |
|
| Eye disorder | Eye disorders | MedDRA 13.1 | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA 13.1 | Systematic Assessment |
|
| Keratoconjunctivitis sicca | Eye disorders | MedDRA 13.1 | Systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA 13.1 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 13.1 | Systematic Assessment |
|
| Visual acuity reduced | Eye disorders | MedDRA 13.1 | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA 13.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Gastritis haemorrhagic | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Perianal erythema | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Reflux oesophagitis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hepatitis | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hepatitis toxic | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hepatotoxicity | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Acute graft versus host disease in intestine | Immune system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Graft versus host disease | Immune system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Anal abscess | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Cytomegalovirus viraemia | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Herpes virus infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Molluscum contagiosum | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Necrotising fasciitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Onychomycosis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Orchitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Tuberculosis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Blood alkaline phosphatase | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Blood creatine increased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Blood test | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Immunosuppressant drug level increased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Ataxia | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dysaesthesia | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Peroneal nerve palsy | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| VIIth nerve paralysis | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| Disorientation | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| Major depression | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| Cystitis haemorrhagic | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Eczema asteatotic | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hypophagia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Measurements |
|---|---|
|
| Not evaluable |
|