ID

16772

Beschrijving

Clinical survey Micafungin Phase NIT Principal Investigator PD Dr. Jörg Janne Vehreschild, Universitätsklinikum Köln Licence:CC-BY

Trefwoorden

Registries

Mycosis Fungoides

Geüploaded op

5 augustus 2016

DOI

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Licentie

Creative Commons BY-NC 3.0

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Clinical survey Micafungin Phase NIT

model
Details

Clinical survey Micafungin Phase NIT

1 Formulieren

StudyEvent: ODM
1. Clinical survey Micafungin Phase NIT

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

Medical History (PGID 272)

Item Group

Medical History (PGID 272)

Body Height

Item

Body Height (q_1140 - Typ 141)

integer

C0005890 (UMLS CUI [1])

Weight

Item

Body weight (q_1141 - Typ 141)

float

C0005910 (UMLS CUI [1])

date of hospitalization

Item

Specifiy the date of hospitalization (q_1143 - Typ 361)

date

C0011008 (UMLS CUI [1,1])
C0030673 (UMLS CUI [1,2])

Date of discharge

Item

Specify the date of discharge from hospital: (q_1232 - Typ 361)

date

C2361123 (UMLS CUI [1])

Department of initial treatment

Item

By which department was the patient treated initially? (q_1144 - Typ 131)

integer

C0037778 (UMLS CUI [1,1])
C2065349 (UMLS CUI [1,2])

Department of initial treatment

Code List

By which department was the patient treated initially? (q_1144 - Typ 131)

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])

Diseases, conditions

Item Group

Specify the underlying diseases/conditions of the patient: (q_1145 - Typ 121)

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])

T-NHL

Item

T-NHL

boolean

C0079772 (UMLS CUI [1,1])
C0024305 (UMLS CUI [1,2])

Item

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])

Treatment

Item Group

Treatment

ICU

Item

Was the patient treated on an ICU when micafungin treatment was initiated? (q_1146 - Typ 111)

integer

C0021708 (UMLS CUI [1])

ICU

Code List

Was the patient treated on an ICU when micafungin treatment was initiated? (q_1146 - Typ 111)

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])

ICU treatment duration

Item

If yes, for how many days was the patient treated on the ICU BEFORE initiation of micafungin treatment? (q_1233 - Typ 141)

integer

C0021708 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])

Indication for treatment

Item Group

Indication for treatment

C3146298 (UMLS CUI-1)

micafungin indication

Item

What was the indication for treatment with micafungin? (q_1147 - Typ 111)

integer

C3146298 (UMLS CUI [1,1])
C1120386 (UMLS CUI [1,2])

micafungin indication

Code List

What was the indication for treatment with micafungin? (q_1147 - Typ 111)

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)

level of evidence for the fungal infection

Item

What was the level of evidence for the fungal infection? (q_1148 - Typ 111)

integer

C0393009 (UMLS CUI [1,1])
C0026946 (UMLS CUI [1,2])

level of evidence for the fungal infection

Code List

What was the level of evidence for the fungal infection? (q_1148 - Typ 111)

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)

Treatment target

Item Group

If applicable, which pathogen(s) was micafungin treatment targeted at? (q_1149 - Typ 121)

C2985566 (UMLS CUI-1)
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])

Involved sites

Item Group

If applicable, which sites were involved in the fungal infection? (q_1150 - Typ 121)

C0729543 (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])

liver infection

Item

Liver

boolean

C0023884 (UMLS CUI [1,1])
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])

Risk Factors

Item Group

Which risk factors for invasive fungal disease were present in the patient? (q_1151 - Typ 121)

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])

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])

Renal failure / dialysis

Item

Renal failure / dialysis

boolean

C1533077 (UMLS CUI [1])
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])

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? (q_1157 - Typ 141)

integer

C0003232 (UMLS CUI [1,1])
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? (q_1158 - Typ 141)

integer

C0854606 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])

APACHE Score

Item Group

APACHE Score

C0243028 (UMLS CUI-1)

apache II calculated

Item

Was the APACHE II score calculated for the patient within 48 hours of micafungin treatment initiation? (q_1156 - Typ 111)

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])

Immunosuppressants

Item Group

Please specify the use of immunosuppressants from the time of hospital admission until initiation of micafungin treatment: (q_1160 - Typ 363)

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])

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])

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])

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])

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])

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])

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])

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])

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])

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])

Types of isolation

Item Group

Please state the types of isolation used accomodating the patient: (q_1161 - Typ 121)

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])

Other Antifungals BEFORE initiation

Item Group

Please state the total daily dose and the days on treatment for antifungal drugs administered BEFORE initiation of micafungin: (q_1162 - Typ 363)

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])

Amphotericin B lipid complex

Item

Amphotericin B lipid complex (Daily Dose (mg))

float

C0002679 (UMLS CUI [1,1])
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])

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])

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])

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])

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])

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])

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])

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])

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])

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])

Other Antifungals AFTER initiation

Item Group

Please state the total daily dose and the days on treatment for antifungal drugs administered AFTER initiation of micafungin: (q_1163 - Typ 363)

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])

Amphotericin B lipid complex

Item

Amphotericin B lipid complex (Daily Dose (mg))

float

C0002679 (UMLS CUI [1,1])
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])

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])

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])

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])

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])

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])

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])

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])

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])

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])

Temperature

Item Group

Temperature

C0005903 (UMLS CUI-1)

high temperature, fungal infection association

Item

Did the patient develop temperature >= 38.0°C possibly associated with the fungal infection treated with micafungin? (q_1202 - Typ 112)

boolean

C1120386 (UMLS CUI [1,1])
C0559546 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,3])

days with high temperature

Item

If yes, please state the total number of days with temperature >= 38.0°C: (q_1203 - Typ 141)

integer

C0015967 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])

first day of high temperature

Item

Specify the first day of temperature >= 38.0°C: (q_1204 - Typ 361)

date

C0015967 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])

date of defervescence

Item

Specify the date of defervescence: (q_1205 - Typ 361)

date

C0424784 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])

Diagnostic procedures

Item Group

Please state the number of diagnostic procedures performed in the given categories, and how many of them showed findings indicative for invasive fungal infections. (q_1201 - Typ 363)

C0430022 (UMLS CUI-1)

CT (Total Qty. Performed)

Item

CT (Total Qty. Performed)

integer

C0040405 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])

MRT (Total Qty. Performed)

Item

MRT (Total Qty. Performed)

integer

C0024485 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])

Sonography (Total Qty. Performed)

Item

Sonography (Total Qty. Performed)

integer

C0041618 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])

Fundoscopy (Total Qty. Performed)

Item

Fundoscopy (Total Qty. Performed)

integer

C0029090 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])

Microbiology/Serology/PCR (Total Qty. Performed)

Item

Microbiology/Serology/PCR (Total Qty. Performed)

integer

C0085672 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0036743 (UMLS CUI [2,1])
C0449788 (UMLS CUI [2,2])
C0032520 (UMLS CUI [3,1])
C0449788 (UMLS CUI [3,2])

Tissue sample (Total Qty. Performed)

Item

Tissue sample (Total Qty. Performed)

integer

C1292533 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])

CT (Qty. Positive)

Item

CT (Qty. Positive)

integer

C0040405 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])

MRT (Qty. Positive)

Item

MRT (Qty. Positive)

integer

C0024485 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])

Sonography (Qty. Positive)

Item

Sonography (Qty. Positive)

integer

C0041618 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])

Fundoscopy (Qty. Positive)

Item

Fundoscopy (Qty. Positive)

integer

C0029090 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])

Microbiology/Serology/PCR (Qty. Positive)

Item

Microbiology/Serology/PCR (Qty. Positive)

integer

C0085672 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
C0036743 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0449788 (UMLS CUI [2,3])
C0032520 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])
C0449788 (UMLS CUI [3,3])

Tissue sample (Qty. Positive)

Item

Tissue sample (Qty. Positive)

integer

C1292533 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])

invasive fungal infection detected by CT, date

Item

CTSpecify the date of the first CT indicative for invasive fungal infection: (q_1182 - Typ 361)

date

C2316983 (UMLS CUI [1,1])
C0040405 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1262313 (UMLS CUI [1,4])

invasive fungal infection detected by MRT, date

Item

MRTSpecify the date of the first MRT indicative for invasive fungal infection: (q_1183 - Typ 361)

date

C2316983 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1262313 (UMLS CUI [1,4])

invasive fungal infection detected by Sonography, date

Item

SonographySpecify the date of the first sonography indicative for invasive fungal infection: (q_1184 - Typ 361)

date

C2316983 (UMLS CUI [1,1])
C0041618 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1262313 (UMLS CUI [1,4])

invasive fungal infection detected by Fundoscopy, date

Item

FundoscopySpecify the date of the first fundoscopy indicative for invasive fungal infection: (q_1185 - Typ 361)

date

C2316983 (UMLS CUI [1,1])
C0029090 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1262313 (UMLS CUI [1,4])

invasive fungal infection detected by microbiological culture, date

Item

MicrobiologySpecify the date of the first microbiological culture indicative for invasive fungal infection: (q_1186 - Typ 361)

date

C2316983 (UMLS CUI [1,1])
C0497094 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1262313 (UMLS CUI [1,4])

invasive fungal infection detected by Tissue specimen, date

Item

Tissue specimenSpecify the date of the first tissue sample indicative of invasive fungal infection: (q_1187 - Typ 361)

date

C2316983 (UMLS CUI [1,1])
C1292533 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1262313 (UMLS CUI [1,4])

Sites of Mycosis, CT finding

Item Group

Please indicate sites with CT abnormalities indicative of invasive fungal infections: (q_1188 - Typ 122)

C0026946 (UMLS CUI-1)
C0578491 (UMLS CUI-2)
C0040405 (UMLS CUI-3)

mycosis of lung

Item

Lung

boolean

C0040405 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0024116 (UMLS CUI [1,3])

mycosis of liver

Item

Liver

boolean

C0040405 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C1262313 (UMLS CUI [1,4])

mycosis of spleen

Item

Spleen

boolean

C0040405 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0037993 (UMLS CUI [1,3])
C1262313 (UMLS CUI [1,4])

mycosis of sinus

Item

Sinus

boolean

C0040405 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1262313 (UMLS CUI [1,3])

mycosis of CNS

Item

CNS

boolean

C0040405 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C3714787 (UMLS CUI [1,3])
C1262313 (UMLS CUI [1,4])

mycosis of kidney

Item

Kidney

boolean

C0040405 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0022646 (UMLS CUI [1,3])
C1262313 (UMLS CUI [1,4])

Other bone lesion

Item

Other bone lesion

boolean

C0040405 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0238792 (UMLS CUI [1,3])

Other soft tissue lesion

Item

Other soft tissue lesion

boolean

C0040405 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0410013 (UMLS CUI [1,3])

CT finding description

Item

Briefly describe the type of finding: (q_1195 - Typ 142)

text

C0040405 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])

Sites of Mycosis, MRT finding

Item Group

Please indicate sites with MRT abnormalities indicative of invasive fungal infections: (q_1189 - Typ 122)

C0026946 (UMLS CUI-1)
C0578491 (UMLS CUI-2)
C0024485 (UMLS CUI-3)

mycosis of lung

Item

Lung

boolean

C0024485 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0024116 (UMLS CUI [1,3])

mycosis of liver

Item

Liver

boolean

C0024485 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C1262313 (UMLS CUI [1,4])

mycosis of spleen

Item

Spleen

boolean

C0024485 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0037993 (UMLS CUI [1,3])
C1262313 (UMLS CUI [1,4])

mycosis of sinus

Item

Sinus

boolean

C0024485 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1262313 (UMLS CUI [1,3])

mycosis of CNS

Item

CNS

boolean

C0024485 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C3714787 (UMLS CUI [1,3])
C1262313 (UMLS CUI [1,4])

mycosis of kidney

Item

Kidney

boolean

C0024485 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0022646 (UMLS CUI [1,3])
C1262313 (UMLS CUI [1,4])

Other bone lesion

Item

Other bone lesion

boolean

C0024485 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0238792 (UMLS CUI [1,3])

Other soft tissue lesion

Item

Other soft tissue lesion

boolean

C0024485 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0410013 (UMLS CUI [1,3])

MRT finding description

Item

Briefly describe the type of finding: (q_1196 - Typ 142)

text

C0024485 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])

Sites of Mycosis, Sonography finding

Item Group

Please indicate sites with sonographical abnormalities indicative of invasive fungal infections: (q_1190 - Typ 122)

C0026946 (UMLS CUI-1)
C0578491 (UMLS CUI-2)
C0041618 (UMLS CUI-3)

mycosis of pleura

Item

Pleura

boolean

C0041618 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0026946 (UMLS CUI [1,3])
C0032225 (UMLS CUI [1,4])

mycosis of liver

Item

Liver

boolean

C0041618 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C1262313 (UMLS CUI [1,4])

mycosis of spleen

Item

Spleen

boolean

C0041618 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0037993 (UMLS CUI [1,3])
C1262313 (UMLS CUI [1,4])

mycosis of kidney

Item

Kidney

boolean

C0041618 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0022646 (UMLS CUI [1,3])
C1262313 (UMLS CUI [1,4])

Other soft tissue lesion

Item

Other soft tissue lesion

boolean

C0041618 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0410013 (UMLS CUI [1,3])

Sonography finding description

Item

Briefly describe the type of finding: (q_1197 - Typ 142)

text

C0041618 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])

Sites of Mycosis, Fundoscopy finding

Item Group

Sites of Mycosis, Fundoscopy finding

Fundoscopy finding description

Item

Briefly describe the type of finding: (q_1198 - Typ 142)

text

C0029090 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])

Sites of Mycosis, microbiological culture finding

Item Group

Please indicate sites/secretions from where microbiological cultures indicative of invasive fungal infection were obtained: (q_1191 - Typ 122)

C0026946 (UMLS CUI-1)
C0578491 (UMLS CUI-2)
C0497094 (UMLS CUI-3)

ascites

Item

Ascites

boolean

C0497094 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0003962 (UMLS CUI [1,3])
C1262313 (UMLS CUI [1,4])

BAL

Item

BAL

boolean

C0497094 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0006279 (UMLS CUI [1,3])
C1262313 (UMLS CUI [1,4])

mycosis in Cerebrospinal fluid

Item

Cerebrospinal fluid

boolean

C0497094 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0007806 (UMLS CUI [1,3])
C1262313 (UMLS CUI [1,4])

mycosis of blood

Item

Blood

boolean

C0497094 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0005767 (UMLS CUI [1,3])
C1262313 (UMLS CUI [1,4])

mycosis detected in deep wound swabs

Item

Deep wound swabs

boolean

C0497094 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1261188 (UMLS CUI [1,3])
C1262313 (UMLS CUI [1,4])

mycosis detected in Nasopharyngeal secretion

Item

Nasopharyngeal secretion

boolean

C0497094 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1546724 (UMLS CUI [1,3])
C1262313 (UMLS CUI [1,4])

mycosis detected in Sinonasal swabs

Item

Sinonasal swabs

boolean

C0497094 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1711241 (UMLS CUI [1,3])
C1261188 (UMLS CUI [1,4])

mycosis in sputum

Item

Sputum

boolean

C0497094 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0038056 (UMLS CUI [1,3])

mycosis of Superficial skin/wound swabs

Item

Superficial skin/wound swabs

boolean

C0497094 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1123023 (UMLS CUI [1,3])
C1261188 (UMLS CUI [1,4])

mycosis detected in Urine

Item

Urine

boolean

C0497094 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0042036 (UMLS CUI [1,3])

microbiologic finding description

Item

Briefly describe the type of finding: (q_1199 - Typ 142)

text

C0497094 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])

Sites of Mycosis, Tissue specimen finding

Item Group

Please indicate sites from which tissue samples indicative of invasive fungal infections were obtained: (q_1192 - Typ 122)

C0026946 (UMLS CUI-1)
C0578491 (UMLS CUI-2)
C1292533 (UMLS CUI-3)

mycosis of lung

Item

Lung

boolean

C1292533 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0024116 (UMLS CUI [1,3])

mycosis of liver

Item

Liver

boolean

C1292533 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C1262313 (UMLS CUI [1,4])

mycosis of spleen

Item

Spleen

text

C1292533 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0037993 (UMLS CUI [1,3])
C1262313 (UMLS CUI [1,4])

mycosis of sinus

Item

Sinus

boolean

C1292533 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1262313 (UMLS CUI [1,3])

mycosis of CNS

Item

CNS

boolean

C1292533 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C3714787 (UMLS CUI [1,3])
C1262313 (UMLS CUI [1,4])

mycosis of kidney

Item

Kidney

boolean

C1292533 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0022646 (UMLS CUI [1,3])
C1262313 (UMLS CUI [1,4])

Other bone lesion

Item

Other bone lesion

boolean

C1292533 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0238792 (UMLS CUI [1,3])

Other soft tissue lesion

Item

Other soft tissue lesion

boolean

C1292533 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0410013 (UMLS CUI [1,3])

biopsy finding description

Item

Briefly describe the type of finding: (q_1200 - Typ 142)

text

C1292533 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])

Method of biopsy

Item Group

By which method were tissue samples with results indicate of invasive fungal infection obtained? (q_1193 - Typ 122)

C0449327 (UMLS CUI-1)

endoscopic biopsy

Item

endoscopic biopsy

boolean

C0184980 (UMLS CUI [1])

blind needle biopsy

Item

blind needle biopsy

boolean

C0005560 (UMLS CUI [1])

guided needle biopsy (CT, sonography)

Item

guided needle biopsy (CT, sonography)

boolean

C2919305 (UMLS CUI [1])
C2919740 (UMLS CUI [2])

surgical biopsy

Item

surgical biopsy

boolean

C0565118 (UMLS CUI [1])

Micafungin Treatment (PGID 280)

Item Group

Micafungin Treatment (PGID 280)

C0013216 (UMLS CUI-1)
C1120386 (UMLS CUI-2)

start date of micafungin treatment

Item

Please state the first day of micafungin treatment: (q_1209 - Typ 361)

date

C0808070 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C1120386 (UMLS CUI [1,3])

loading dose

Item

Please state the dosage (mg) used for the first application micafungin (loading dose): (q_1207 - Typ 141)

float

C1120386 (UMLS CUI [1,1])
C3714444 (UMLS CUI [1,2])

maintenance dose

Item

Please state the dosage (mg) used after first application of micafungin (maintenance dose): (q_1206 - Typ 141)

float

C1120386 (UMLS CUI [1,1])
C3714445 (UMLS CUI [1,2])

treatment duration

Item

For how many days was the patient treated with micafungin? (q_1208 - Typ 141)

integer

C0449238 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C1120386 (UMLS CUI [1,3])

hematopoietic growth factors

Item

Did the patient receive hematopoietic growth factors (e.g. G-CSF)? (q_1211 - Typ 111)

boolean

C0079490 (UMLS CUI [1])

concomitant medication

Item

Did the patient receive any other concomitant medication, that might have influenced treatment outcome or tolerability/efficacy of micafungin? (q_1212 - Typ 111)

boolean

C2347852 (UMLS CUI [1])

concomitant medication duration

Item

If yes, please state the days on treatment with that drug and the total daily dose administered: (q_1213 - Typ 144)

integer

C2347852 (UMLS CUI [1,1])
C0444921 (UMLS CUI [1,2])

CYP450 inductors DURING treatment

Item Group

Please state the number of days and the dosage of the following CYP450 inductors used DURING treatment with micafungin: (q_1210 - Typ 363)

C3850052 (UMLS CUI-1)

Rifampicin (Daily Dose (mg))

Item

Rifampicin (Daily Dose (mg))

float

C0035608 (UMLS CUI [1])

Rifampicin (Days on Treatment)

Item

Rifampicin (Days on Treatment)

integer

C0035608 (UMLS CUI [1,1])
C0444921 (UMLS CUI [1,2])

Phenytoin (Daily Dose (mg))

Item

Phenytoin (Daily Dose (mg))

float

C0031507 (UMLS CUI [1,1])
C0230707 (UMLS CUI [1,2])

Phenytoin (Days on Treatment)

Item

Phenytoin (Days on Treatment)

integer

C0031507 (UMLS CUI [1,1])
C0444921 (UMLS CUI [1,2])

Carbamazepine (Daily Dose (mg))

Item

Carbamazepine (Daily Dose (mg))

float

C0006949 (UMLS CUI [1])

Carbamazepine (Days on Treatment)

Item

Carbamazepine (Days on Treatment)

integer

C0006949 (UMLS CUI [1,1])
C0444921 (UMLS CUI [1,2])

Dexamethasone (Daily Dose (mg))

Item

Dexamethasone (Daily Dose (mg))

float

C0011777 (UMLS CUI [1])

Dexamethasone (Days on Treatment)

Item

Dexamethasone (Days on Treatment)

integer

C0011777 (UMLS CUI [1,1])
C0444921 (UMLS CUI [1,2])

Efavirenz (Daily Dose (mg))

Item

Efavirenz (Daily Dose (mg))

float

C0674428 (UMLS CUI [1])

Efavirenz (Days on Treatment)

Item

Efavirenz (Days on Treatment)

integer

C0674428 (UMLS CUI [1,1])
C0444921 (UMLS CUI [1,2])

Nevirapine (Daily Dose (mg))

Item

Nevirapine (Daily Dose (mg))

float

C0132326 (UMLS CUI [1])

Nevirapine (Days on Treatment)

Item

Nevirapine (Days on Treatment)

integer

C0132326 (UMLS CUI [1,1])
C0444921 (UMLS CUI [1,2])

Breakthrough Infections (PGID 281)

Item Group

Did breakthrough fungal infections occur during treatment with micafungin? (q_1214 - Typ 121)

C3666010 (UMLS CUI-1)

aspergillosis breakthrough infection

Item

Aspergillosis

boolean

C3666010 (UMLS CUI [1,1])
C0004030 (UMLS CUI [1,2])

Candidiasis, species breakthrough infection

Item

Candidiasis, species:

boolean

C3666010 (UMLS CUI [1,1])
C0006840 (UMLS CUI [1,2])

Fusariosis breakthrough infection

Item

Fusariosis

boolean

C3666010 (UMLS CUI [1,1])
C0276758 (UMLS CUI [1,2])

Zygomycosis, species breakthrough infection

Item

Zygomycosis, species:

boolean

C3666010 (UMLS CUI [1,1])
C0043541 (UMLS CUI [1,2])

other species breakthrough infection

Item

other species

boolean

C3666010 (UMLS CUI [1])

Adverse Events

Item Group

Which of the following adverse events occurred during treatment that were at least remotely related to micafungin? (q_1215 - Typ 121)

C0877248 (UMLS CUI-1)
C1120386 (UMLS CUI-2)

adverse event: chills

Item

Chills

boolean

C0877248 (UMLS CUI [1,1])
C0085593 (UMLS CUI [1,2])

adverse event: Diarrhea

Item

Diarrhea

boolean

C0877248 (UMLS CUI [1,1])
C0011991 (UMLS CUI [1,2])

adverse event: Phlebitis

Item

Phlebitis

boolean

C0877248 (UMLS CUI [1,1])
C0031542 (UMLS CUI [1,2])

adverse event: Skin rash

Item

Skin rash

boolean

C0877248 (UMLS CUI [1,1])
C0015230 (UMLS CUI [1,2])

adverse event: Thrombocytopenia

Item

Thrombocytopenia

boolean

C0877248 (UMLS CUI [1,1])
C0040034 (UMLS CUI [1,2])

adverse event: Other, please give a list:

Item

Other, please give a list:

text

C0877248 (UMLS CUI [1])

AE causing prolongation of hospitalization or re-hospitalization

Item

Did any adverse event during treatment with micafungin or during follow up cause prolongation of hospitalization or the need of unscheduled re-hospitalization after discharge? (q_1216 - Typ 111)

boolean

C1548168 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
C1120386 (UMLS CUI [1,3])
C0877248 (UMLS CUI [1,4])

AE causing permanent impairment of any body function

Item

Did any adverse event during treatment with micafungin or during follow up cause permanent impairment of any body function? (q_1217 - Typ 111)

boolean

C0221099 (UMLS CUI [1,1])
C0205355 (UMLS CUI [1,2])
C1120386 (UMLS CUI [1,3])
C0877248 (UMLS CUI [1,4])

AE causing life threatening condition

Item

Did any adverse event during treatment with micafungin or during follow up cause a life threatening condition? (q_1218 - Typ 111)

boolean

C1517874 (UMLS CUI [1,1])
C1120386 (UMLS CUI [1,2])

congenital anomalies during treatment

Item

Do you know of any congenital anomalies occur in children born during treatment or follow up? (q_1219 - Typ 111)

boolean

C0000768 (UMLS CUI [1,1])
C2709058 (UMLS CUI [1,2])

any other SAE

Item

Did any other severe adverse event occur during treatment with micafungin or during follow (e.g. abnormal laboratory findings)? (q_1220 - Typ 111)

boolean

C1519255 (UMLS CUI [1])

Laboratory Parameters (PGID 283)

Item Group

Please specify the laboratory parameters before and during micafungin treatent. (q_1164 - Typ 363)

C0587081 (UMLS CUI-1)

GOT (U/l) (Before micafungin treatment)

Item

GOT (U/l) (Before micafungin treatment)

float

C0201899 (UMLS CUI [1,1])
C2709094 (UMLS CUI [1,2])

GPT (U/l) (Before micafungin treatment)

Item

GPT (U/l) (Before micafungin treatment)

float

C0201836 (UMLS CUI [1,1])
C2709094 (UMLS CUI [1,2])

GGT (U/l) (Before micafungin treatment)

Item

GGT (U/l) (Before micafungin treatment)

float

C0202035 (UMLS CUI [1,1])
C2709094 (UMLS CUI [1,2])

Bilirubin (mg/dl) (Before micafungin treatment)

Item

Bilirubin (mg/dl) (Before micafungin treatment)

float

C0201913 (UMLS CUI [1,1])
C2709094 (UMLS CUI [1,2])

Alkaline phosphatase (U/l) (Before micafungin treatment)

Item

Alkaline phosphatase (U/l) (Before micafungin treatment)

float

C0002059 (UMLS CUI [1,1])
C2709094 (UMLS CUI [1,2])

LDH (U/l) (Before micafungin treatment)

Item

LDH (U/l) (Before micafungin treatment)

float

C0202113 (UMLS CUI [1,1])
C2709094 (UMLS CUI [1,2])

Creatinine (mg/dl) (Before micafungin treatment)

Item

Creatinine (mg/dl) (Before micafungin treatment)

float

C0201975 (UMLS CUI [1,1])
C2709094 (UMLS CUI [1,2])

GOT (U/l) (During micafungin treatment)

Item

GOT (U/l) (During micafungin treatment)

float

C0201899 (UMLS CUI [1,1])
C2709058 (UMLS CUI [1,2])

GPT (U/l) (During micafungin treatment)

Item

GPT (U/l) (During micafungin treatment)

float

C0201836 (UMLS CUI [1,1])
C2709058 (UMLS CUI [1,2])

GGT (U/l) (During micafungin treatment)

Item

GGT (U/l) (During micafungin treatment)

float

C0202035 (UMLS CUI [1,1])
C2709058 (UMLS CUI [1,2])

Bilirubin (mg/dl) (During micafungin treatment)

Item

Bilirubin (mg/dl) (During micafungin treatment)

float

C0201913 (UMLS CUI [1,1])
C2709058 (UMLS CUI [1,2])

Alkaline phosphatase (U/l) (During micafungin treatment)

Item

Alkaline phosphatase (U/l) (During micafungin treatment)

float

C0201850 (UMLS CUI [1,1])
C2709058 (UMLS CUI [1,2])

LDH (U/l) (During micafungin treatment)

Item

LDH (U/l) (During micafungin treatment)

float

C0202113 (UMLS CUI [1,1])
C2709058 (UMLS CUI [1,2])

Creatinine (mg/dl) (During micafungin treatment)

Item

Creatinine (mg/dl) (During micafungin treatment)

float

C0201975 (UMLS CUI [1,1])
C2709058 (UMLS CUI [1,2])

neutrophil count

Item

Did the patient show a neutrophil count < 500 /µl at any time during treatment? (q_1152 - Typ 112)

boolean

C0200633 (UMLS CUI [1])

date of neutropenia

Item

If patient had neutropenia, what was the first day with a neutrophile count < 500 /µl? (q_1153 - Typ 361)

date

C0808070 (UMLS CUI [1,1])
C0027947 (UMLS CUI [1,2])

end date of neutropenia

Item

If patient had neutropenia, what was the last day with a neutrophile count < 500 /µl? (q_1154 - Typ 361)

date

C0806020 (UMLS CUI [1,1])
C0027947 (UMLS CUI [1,2])

Outcome Micafungin (PGID 284)

Item Group

Outcome Micafungin (PGID 284)

C1120386 (UMLS CUI-1)
C0085415 (UMLS CUI-2)

micafungin outcome

Item

Please judge the outcome of MICAFUNGIN treatment: (q_1221 - Typ 111)

integer

C1120386 (UMLS CUI [1,1])
C0085415 (UMLS CUI [1,2])

micafungin outcome

Code List

Please judge the outcome of MICAFUNGIN treatment: (q_1221 - Typ 111)

CL Item

Response (1)

CL Item

Stabilization (2)

CL Item

Failure (3)

treatment switch

Item

Did you switch to another antifungal drug at the end of micafungin treatment? (q_1222 - Typ 111)

boolean

C0580105 (UMLS CUI [1,1])
C0003308 (UMLS CUI [1,2])

if yes, reason for switch

Item

If yes, give the reason for the switch

text

C0392360 (UMLS CUI [1,1])
C0580105 (UMLS CUI [1,2])

if yes, dose used

Item

and the dose used: (q_1223 - Typ 144)

float

C3174092 (UMLS CUI [1,1])
C0580105 (UMLS CUI [1,2])

eradication of pathogen through treatment

Item

Was eradication of the causative pathogen achieved during MICAFUNGIN treatment? (q_1224 - Typ 112)

boolean

C2728502 (UMLS CUI [1,1])
C1120386 (UMLS CUI [1,2])

days spent on ICU during treatment

Item

What was the total amount of days spent on the ICU during micafungin treatment? (q_1235 - Typ 141)

integer

C0021708 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])

ICU during treatment

Item

Was the patient transferred to the ICU during micafungin treatment? (q_1234 - Typ 112)

boolean

C0021708 (UMLS CUI [1])

treatment survival

Item

Was the patient alive at the end of MICAFUNGIN treatment? (q_1225 - Typ 112)

boolean

C0011065 (UMLS CUI [1])

treatment related death

Item

If not, was death related to the fungal infection? (q_1226 - Typ 112)

boolean

C0007465 (UMLS CUI [1,1])
C0026946 (UMLS CUI [1,2])

Other Antifungal, Outcome Final Antifungal Treatment (PGID 286)

Item Group

Other Antifungal, Outcome Final Antifungal Treatment (PGID 286)

C0085415 (UMLS CUI-1)
C0003308 (UMLS CUI-2)

v_442 treatment outcome

Item

Please judge the outcome of #v_442# treatment: (q_1227 - Typ 111)

integer

C0085415 (UMLS CUI [1])

v_442 treatment outcome

Code List

Please judge the outcome of #v_442# treatment: (q_1227 - Typ 111)

CL Item

Response (1)

CL Item

Stabilization (2)

CL Item

Failure (3)

eradication through treatment

Item

Was eradication of the causative pathogen achieved during #v_442# treatment? (q_1228 - Typ 112)

boolean

C2728502 (UMLS CUI [1])

v_442 treatment survival

Item

Was the patient alive at the end of #v_442# treatment? (q_1229 - Typ 112)

boolean

C0011065 (UMLS CUI [1])

v_442 treatment related death

Item

If not, was death related to the fungal infection? (q_1230 - Typ 112)

boolean

C0007465 (UMLS CUI [1,1])
C0026946 (UMLS CUI [1,2])

Follow Up (PGID 287)

Item Group

Follow Up (PGID 287)

C1522577 (UMLS CUI-1)

fungal infection relapse

Item

Did the fungal infection treated with micafungin relapse within 28 days after treatment discontinuation? (q_1236 - Typ 112)

integer

C0035020 (UMLS CUI [1,1])
C0026946 (UMLS CUI [1,2])
C0558681 (UMLS CUI [1,3])
C1120386 (UMLS CUI [1,4])

fungal infection relapse

Code List

Did the fungal infection treated with micafungin relapse within 28 days after treatment discontinuation? (q_1236 - Typ 112)

CL Item

No (1)

CL Item

Yes (2)

CL Item

Unknown (3)

comments

Item

Please give any comments or suggestions that you have, be it on the documented case or on the survey as a whole: (q_1413 - Typ 142)

text

C0947611 (UMLS CUI [1])

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Clinical survey Micafungin Phase NIT

Clinical survey Micafungin Phase NIT

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