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ID
16643
Beschrijving
Clinical survey Micafungin Phase NIT Principal Investigator PD Dr. Jörg Janne Vehreschild, Universitätsklinikum Köln Licence:CC-BY
Trefwoorden
Versies (6)
- 28-07-16 28-07-16 -
- 28-07-16 28-07-16 -
- 28-07-16 28-07-16 -
- 28-07-16 28-07-16 -
- 29-07-16 29-07-16 -
- 05-08-16 05-08-16 -
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28 juli 2016
DOI
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Creative Commons BY-NC 3.0 Legacy
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Clinical survey Micafungin Phase NIT
Clinical survey Micafungin Phase NIT
- StudyEvent: ODM
Similar models
Clinical survey Micafungin Phase NIT
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Body Height
Item
Body Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Body weight
float
C0005910 (UMLS CUI [1])
date of hospitalization
Item
Specifiy the date of hospitalization
date
C0011008 (UMLS CUI [1,1])
C0030673 (UMLS CUI [1,2])
C0030673 (UMLS CUI [1,2])
Date of discharge
Item
Specify the date of discharge from hospital:
date
C2361123 (UMLS CUI [1])
Item
By which department was the patient treated initially?
integer
C0037778 (UMLS CUI [1,1])
C2065349 (UMLS CUI [1,2])
C2065349 (UMLS CUI [1,2])
CL Item
Hematology/oncology (1)
CL Item
Surgery, visceral (2)
CL Item
Surgery, traumatology (3)
CL Item
Surgery, thoracic (4)
CL Item
Nephrology (5)
CL Item
Infectious Diseases (6)
CL Item
Cardiology (7)
CL Item
Ear/Nose/Throat (8)
CL Item
Ophthalmology (9)
CL Item
Other: (10)
other specialty
Item
if previous answered with "other", please specify
text
C0037778 (UMLS CUI [1])
Item Group
Specify the underlying diseases/conditions of the patient:
C0011900 (UMLS CUI-1)
AML
Item
AML
boolean
C0023467 (UMLS CUI [1])
ALL
Item
ALL
boolean
C0023449 (UMLS CUI [1])
CML
Item
CML
boolean
C0023474 (UMLS CUI [1])
CLL
Item
CLL
boolean
C0023434 (UMLS CUI [1])
MDS
Item
MDS
boolean
C3463824 (UMLS CUI [1])
Multiple Myeloma
Item
Multiple Myeloma
boolean
C0026764 (UMLS CUI [1])
B-NHL
Item
B-NHL
text
C0079731 (UMLS CUI [1,1])
C0024305 (UMLS CUI [1,2])
C0024305 (UMLS CUI [1,2])
T-NHL
Item
T-NHL
boolean
C0079772 (UMLS CUI [1,1])
C0024305 (UMLS CUI [1,2])
C0024305 (UMLS CUI [1,2])
HD
Item
HD
boolean
C0019829 (UMLS CUI [1])
Autologous Stem Cell Transplantation
Item
Autologous Stem Cell Transplantation
boolean
C1831743 (UMLS CUI [1])
Allogeneic Stem Cell Transplantation
Item
Allogeneic Stem Cell Transplantation
boolean
C2242529 (UMLS CUI [1])
Lung disease
Item
Lung
boolean
C0024115 (UMLS CUI [1])
Kidney disease
Item
Kidney
boolean
C0022658 (UMLS CUI [1])
Liver disease
Item
Liver
boolean
C0023895 (UMLS CUI [1])
Pancreas disease
Item
Pancreas
boolean
C0030274 (UMLS CUI [1])
Heart disease
Item
Heart
boolean
C0018799 (UMLS CUI [1])
Organ Transplantation
Item
Other Solid Organ Transplantation
boolean
C0029216 (UMLS CUI [1])
HIV/AIDS
Item
HIV/AIDS
boolean
C0019682 (UMLS CUI [1])
Neurosurgical intervention
Item
Neurosurgical intervention
boolean
C0524850 (UMLS CUI [1])
Diabetes mellitus
Item
Diabetes mellitus
boolean
C0011849 (UMLS CUI [1])
Solid tumor
Item
Solid tumor:
boolean
C0280100 (UMLS CUI [1])
other
Item
other
text
C0012634 (UMLS CUI [1])
Item
Was the patient treated on an ICU when micafungin treatment was initiated?
integer
C0021708 (UMLS CUI [1])
CL Item
Surgical ICU (1)
CL Item
Medical ICU (2)
CL Item
Anaethesiological ICU (3)
CL Item
Neurological / Neurosurgical ICU (4)
CL Item
Other: (5)
CL Item
Patient was not treated on ICU (6)
other icu
Item
if previous answered with "other", please specify
text
C0021708 (UMLS CUI [1,1])
C0037778 (UMLS CUI [1,2])
C0037778 (UMLS CUI [1,2])
ICU treatment duration
Item
If yes, for how many days was the patient treated on the ICU BEFORE initiation of micafungin treatment?
integer
C0021708 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,2])
Item
What was the indication for treatment with micafungin?
integer
C3146298 (UMLS CUI [1,1])
C1120386 (UMLS CUI [1,2])
C1120386 (UMLS CUI [1,2])
CL Item
Antifungal prophylaxis (1)
CL Item
Empirical antifungal treatment (2)
CL Item
Current fungal infection (3)
CL Item
Secondary prophylaxis (4)
CL Item
Treatment failure of earlier antifungal treatment (5)
Item
What was the level of evidence for the fungal infection?
integer
C0393009 (UMLS CUI [1,1])
C0026946 (UMLS CUI [1,2])
C0026946 (UMLS CUI [1,2])
Code List
What was the level of evidence for the fungal infection?
CL Item
No evidence of invasive fungal infection (1)
CL Item
Possible invasive fungal infection (2)
CL Item
Probable invasive fungal infection (3)
CL Item
Proven invasive fungal infection (4)
CL Item
I don't have access to the revised EORTC/MSG criteria (5)
Item Group
If applicable, which pathogen(s) was micafungin treatment targeted at?
C2985566 (UMLS CUI-1)
C0450254 (UMLS CUI-2)
C0450254 (UMLS CUI-2)
Candida
Item
Candida spp
boolean
C0006837 (UMLS CUI [1])
Aspergillus
Item
Aspergillus spp
boolean
C0004034 (UMLS CUI [1])
other pathogen
Item
other pathogen
text
C0445623 (UMLS CUI [1])
Blood infection
Item
Blood
boolean
C0729774 (UMLS CUI [1])
Lung infection
Item
Lung
boolean
C0876973 (UMLS CUI [1])
Spleen infection
Item
Spleen
boolean
C0578491 (UMLS CUI [1,1])
C0037993 (UMLS CUI [1,2])
C0037993 (UMLS CUI [1,2])
liver infection
Item
Liver
boolean
C0023884 (UMLS CUI [1,1])
C0578491 (UMLS CUI [1,2])
C0578491 (UMLS CUI [1,2])
Kidney infection
Item
Kidney
boolean
C0021313 (UMLS CUI [1])
cns infection
Item
CNS
boolean
C0007684 (UMLS CUI [1])
skin infection
Item
Skin
boolean
C0037278 (UMLS CUI [1])
other infected site
Item
Other
text
C0578491 (UMLS CUI [1])
Item Group
Which risk factors for invasive fungal disease were present in the patient?
C0035648 (UMLS CUI-1)
Candida colonization
Item
Candida colonization
boolean
C0006840 (UMLS CUI [1])
Central venous catheter
Item
Central venous catheter
boolean
C1145640 (UMLS CUI [1])
Dust exposure
Item
Dust exposure
boolean
C0239200 (UMLS CUI [1])
Chemotherapy
Item
Chemotherapy (any) during the last 4 week
boolean
C0392920 (UMLS CUI [1])
gvhd
Item
Graft versus Host Disease (GvHD)
boolean
C0018133 (UMLS CUI [1])
Mechanical ventilation
Item
Mechanical ventilation
boolean
C0199470 (UMLS CUI [1])
Mucositis
Item
Mucositis CTCAE grade III - IV (if not assessable: unable to take in food, need of analgetics)
boolean
C3888020 (UMLS CUI [1,1])
C0333355 (UMLS CUI [1,2])
C0333355 (UMLS CUI [1,2])
Parenteral nutrition
Item
Parenteral nutrition
boolean
C0030547 (UMLS CUI [1])
Prolonged ICU stay
Item
Prolonged ICU stay (> 4 days)
boolean
C0021708 (UMLS CUI [1,1])
C0420496 (UMLS CUI [1,2])
C0420496 (UMLS CUI [1,2])
Renal failure / dialysis
Item
Renal failure / dialysis
boolean
C1533077 (UMLS CUI [1])
C0011946 (UMLS CUI [2])
C0011946 (UMLS CUI [2])
Surgical procedure
Item
Surgical procedure
boolean
C0543467 (UMLS CUI [1])
T-cell depleting agents
Item
T-cell depleting agents (alemtuzumab, fludarabine) during the last 8 weeks
boolean
C0677960 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
other risk factor
Item
other risk factor
text
C0035648 (UMLS CUI [1])
count of antibacterial drugs
Item
How many different systemically active antibacterial drugs did the patient receive from the time of admission until initiation of micafungin?
integer
C0003232 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
days on antibiotic treatment
Item
For how many days had the patient been on antibiotic treatment before initiation of micafungin therapy?
integer
C0854606 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,2])
apache II calculated
Item
Was the APACHE II score calculated for the patient within 48 hours of micafungin treatment initiation?
boolean
C0243028 (UMLS CUI [1])
if yes, apache II score
Item
APACHE II Score
integer
C0243028 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,2])
Item Group
Please specify the use of immunosuppressants from the time of hospital admission until initiation of micafungin treatment:
C0021081 (UMLS CUI-1)
Azathioprine
Item
Azathioprine (Total Daily Dose (mg))
float
C0004482 (UMLS CUI [1])
Azathioprine
Item
Azathioprine (Days treated)
integer
C0004482 (UMLS CUI [1,1])
C0444921 (UMLS CUI [1,2])
C0444921 (UMLS CUI [1,2])
Corticosteroids
Item
Corticosteroids (use prednisone equivalents) (Total Daily Dose (mg))
float
C0001617 (UMLS CUI [1])
Corticosteroids
Item
Corticosteroids (use prednisone equivalents) (Days Treated)
integer
C0001617 (UMLS CUI [1,1])
C0444921 (UMLS CUI [1,2])
C0444921 (UMLS CUI [1,2])
Cyclophosphamide
Item
Cyclophosphamide (Total Daily Dose (mg))
float
C0010583 (UMLS CUI [1])
Cyclophosphamide
Item
Cyclophosphamide (Days Treated)
integer
C0010583 (UMLS CUI [1,1])
C0444921 (UMLS CUI [1,2])
C0444921 (UMLS CUI [1,2])
Cyclosporine A
Item
Cyclosporine A (give lower limit of target serum level instead of daily dose) (Total Daily Dose (mg))
float
C0010592 (UMLS CUI [1])
Cyclosporine A
Item
Cyclosporine A (give lower limit of target serum level instead of daily dose) (Days Treated)
integer
C0010592 (UMLS CUI [1,1])
C0444921 (UMLS CUI [1,2])
C0444921 (UMLS CUI [1,2])
Daclizumab
Item
Daclizumab (Total Daily Dose (mg))
float
C0663182 (UMLS CUI [1])
Daclizumab
Item
Daclizumab (Days Treated)
integer
C0663182 (UMLS CUI [1,1])
C0444921 (UMLS CUI [1,2])
C0444921 (UMLS CUI [1,2])
Infliximab
Item
Infliximab (Total Daily Dose (mg))
float
C0666743 (UMLS CUI [1])
Infliximab
Item
Infliximab (Days Treated)
integer
C0666743 (UMLS CUI [1,1])
C0444921 (UMLS CUI [1,2])
C0444921 (UMLS CUI [1,2])
Methotrexate
Item
Methotrexate (Total Daily Dose (mg))
float
C0025677 (UMLS CUI [1])
Methotrexate
Item
Methotrexate (Days Treated)
integer
C0025677 (UMLS CUI [1,1])
C0444921 (UMLS CUI [1,2])
C0444921 (UMLS CUI [1,2])
Mycophenolatemofetil
Item
Mycophenolatemofetil (Total Daily Dose (mg))
float
C0209368 (UMLS CUI [1])
Mycophenolatemofetil
Item
Mycophenolatemofetil (Days Treated)
integer
C0209368 (UMLS CUI [1,1])
C0444921 (UMLS CUI [1,2])
C0444921 (UMLS CUI [1,2])
Sirolimus
Item
Sirolimus (give lower limit of target serum level instead of daily dose) (Total Daily Dose (mg))
float
C0072980 (UMLS CUI [1])
Sirolimus
Item
Sirolimus (give lower limit of target serum level instead of daily dose) (Days Treated)
integer
C0072980 (UMLS CUI [1,1])
C0444921 (UMLS CUI [1,2])
C0444921 (UMLS CUI [1,2])
Tacrolimus
Item
Tacrolimus (give lower limit of target serum level instead of daily dose) (Total Daily Dose (mg))
float
C0085149 (UMLS CUI [1])
Tacrolimus
Item
Tacrolimus (give lower limit of target serum level instead of daily dose) (Days Treated)
integer
C0085149 (UMLS CUI [1,1])
C0444921 (UMLS CUI [1,2])
C0444921 (UMLS CUI [1,2])
Item Group
Please state the types of isolation used accomodating the patient:
C0204727 (UMLS CUI-1)
LAF (Laminar Air Flow)
Item
LAF (Laminar Air Flow)
boolean
C0181507 (UMLS CUI [1])
HEPA (High Efficiency Particulate Air Filtration)
Item
HEPA (High Efficiency Particulate Air Filtration)
boolean
C0262772 (UMLS CUI [1])
Reverse isolation
Item
Reverse isolation
boolean
C0179881 (UMLS CUI [1])
No isolation
Item
No isolation
boolean
C0205409 (UMLS CUI [1])
Item Group
Please state the total daily dose and the days on treatment for antifungal drugs administered BEFORE initiation of micafungin:
C0003308 (UMLS CUI-1)
Amphotericin B deoxycholate
Item
Amphotericin B deoxycholate (Daily Dose (mg))
float
C0051761 (UMLS CUI [1])
Amphotericin B deoxycholate
Item
Amphotericin B deoxycholate (Days on Treatment)
integer
C0051761 (UMLS CUI [1,1])
C0444921 (UMLS CUI [1,2])
C0444921 (UMLS CUI [1,2])
Amphotericin B lipid complex
Item
Amphotericin B lipid complex (Daily Dose (mg))
float
C0002679 (UMLS CUI [1,1])
C0230707 (UMLS CUI [1,2])
C0230707 (UMLS CUI [1,2])
Amphotericin B lipid complex
Item
Amphotericin B lipid complex (Days on Treatment)
integer
C0002679 (UMLS CUI [1,1])
C0230707 (UMLS CUI [1,2])
C0444921 (UMLS CUI [1,3])
C0230707 (UMLS CUI [1,2])
C0444921 (UMLS CUI [1,3])
Amphotericin B, liposomal
Item
Amphotericin B, liposomal (Daily Dose (mg))
float
C1145701 (UMLS CUI [1])
Amphotericin B, liposomal
Item
Amphotericin B, liposomal (Days on Treatment)
integer
C1145701 (UMLS CUI [1,1])
C0444921 (UMLS CUI [1,2])
C0444921 (UMLS CUI [1,2])
Caspofungin
Item
Caspofungin (Daily Dose (mg))
float
C0537894 (UMLS CUI [1])
Caspofungin
Item
Caspofungin (Days on Treatment)
integer
C0537894 (UMLS CUI [1,1])
C0444921 (UMLS CUI [1,2])
C0444921 (UMLS CUI [1,2])
Voriconazole
Item
Voriconazole (Daily Dose (mg))
float
C0393080 (UMLS CUI [1])
Voriconazole
Item
Voriconazole (Days on Treatment)
integer
C0393080 (UMLS CUI [1,1])
C0444921 (UMLS CUI [1,2])
C0444921 (UMLS CUI [1,2])
Fluconazole
Item
Fluconazole (Daily Dose (mg))
float
C0016277 (UMLS CUI [1])
Fluconazole
Item
Fluconazole (Days on Treatment)
integer
C0016277 (UMLS CUI [1,1])
C0444921 (UMLS CUI [1,2])
C0444921 (UMLS CUI [1,2])
Isavuconazole
Item
Isavuconazole (Daily Dose (mg))
float
C1832021 (UMLS CUI [1])
Isavuconazole
Item
Isavuconazole (Days on Treatment)
integer
C1832021 (UMLS CUI [1,1])
C0444921 (UMLS CUI [1,2])
C0444921 (UMLS CUI [1,2])
Itraconazole
Item
Itraconazole (Daily Dose (mg))
float
C0064113 (UMLS CUI [1])
Itraconazole
Item
Itraconazole (Days on Treatment)
integer
C0064113 (UMLS CUI [1,1])
C0444921 (UMLS CUI [1,2])
C0444921 (UMLS CUI [1,2])
Ketoconazole
Item
Ketoconazole (Daily Dose (mg))
float
C0022625 (UMLS CUI [1])
Ketoconazole
Item
Ketoconazole (Days on Treatment)
integer
C0022625 (UMLS CUI [1,1])
C0444921 (UMLS CUI [1,2])
C0444921 (UMLS CUI [1,2])
Micafungin
Item
Micafungin (Daily Dose (mg))
float
C1120386 (UMLS CUI [1])
Micafungin
Item
Micafungin (Days on Treatment)
integer
C1120386 (UMLS CUI [1,1])
C0444921 (UMLS CUI [1,2])
C0444921 (UMLS CUI [1,2])
Posaconazole dose
Item
Posaconazole (Daily Dose (mg))
float
C0936148 (UMLS CUI [1])
Posaconazole duration
Item
Posaconazole (Days on Treatment)
integer
C0936148 (UMLS CUI [1,1])
C0444921 (UMLS CUI [1,2])
C0444921 (UMLS CUI [1,2])