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12632

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A Study of Caspofungin, Liposomal Amphotericin B or the Combination of Both for Patients After Stem-Cell Transplantation NCT00148148

Nyckelord

  1. 2015-11-10 2015-11-10 -
  2. 2015-11-11 2015-11-11 -
  3. 2015-12-07 2015-12-07 -
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7 december 2015

DOI

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Creative Commons BY-NC 3.0

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    Day of last Dose-Toxicity Stem-Cell Transplantation CASLAMB NCT00148148

    Day of last Dose-Toxicity Stem-Cell Transplantation CASLAMB NCT00148148

    Allergien
    Beskrivning

    Allergien

    Allergische Reaktionen / Überempfindlichkeit
    Beskrivning

    Allergic reaction / hypersensitivity

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0020517
    Verfassung
    Beskrivning

    Verfassung

    Fieber
    Beskrivning

    Fever

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0015967
    Schüttelfrost
    Beskrivning

    Rigors, chills

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0036973
    Haut
    Beskrivning

    Haut

    Ausschlag
    Beskrivning

    Rash

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0015230
    Nesselausschlag
    Beskrivning

    Urticaria

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0042109
    Magen-Darm
    Beskrivning

    Magen-Darm

    Übelkeit
    Beskrivning

    Nausea

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0027497
    Erbrechen
    Beskrivning

    Vomiting

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0042963
    Leber
    Beskrivning

    Leber

    Alkalische Phosphatase
    Beskrivning

    Alkaline Phosphatase

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0002059
    Bilirubin
    Beskrivning

    Bilirubin, total measurement

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0201913
    SGOT
    Beskrivning

    SGOT

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0201899
    SGPT
    Beskrivning

    SGPT

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0001899
    Metabolisch / Labor
    Beskrivning

    Metabolisch / Labor

    Übersäuerung
    Beskrivning

    Acidosis

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0001122
    Amylase
    Beskrivning

    Amylase

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0201883
    Hypokaliämie
    Beskrivning

    Hypokalemia

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0020621
    Hypomagnesiämie
    Beskrivning

    Hypomagnesemia

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0151723
    Lipase
    Beskrivning

    Lipase

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0023764
    Lungen
    Beskrivning

    Lungen

    Dyspnoe
    Beskrivning

    Dyspnea

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0013404
    Schmerz
    Beskrivning

    Schmerz

    Bauchschmerzen
    Beskrivning

    Abdominal pain

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0000737
    Brustschmerz
    Beskrivning

    Chest pain

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0008031
    Kopfschmerz
    Beskrivning

    Headache

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0018681
    Myalgie
    Beskrivning

    Myalgia

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0231528
    Renal / Genitourinary
    Beskrivning

    Renal / Genitourinary

    Kreatinin
    Beskrivning

    Creatinine

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0010294
    Nierenversagen
    Beskrivning

    Kidney Failure

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0035078
    Anhang VI: BMT-Komplex
    Beskrivning

    Anhang VI: BMT-Komplex

    Abstoßung des Transplantats (graft failure)
    Beskrivning

    Engraft failure

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C2242642
    GVHD
    Beskrivning

    GVHD

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0018133
    Venenverschlusskrankheit
    Beskrivning

    Venoocclusive disease

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0948441

    Similar models

    Day of last Dose-Toxicity Stem-Cell Transplantation CASLAMB NCT00148148

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Allergien
    Item
    Allergische Reaktionen / Überempfindlichkeit
    integer
    C0020517 (UMLS CUI [1])
    Code List
    Allergische Reaktionen / Überempfindlichkeit
    CL Item
    Grad 0 (none) (1)
    CL Item
    Grad 1 (transient rash, drug fever <38C) (2)
    CL Item
    Grad 2 (urticaria, drug fever 38C, and/or asymptomatic bronchospasm) (3)
    CL Item
    Grad 3 (symptomatic bronchospasm, requiring parenteral medication/s, with or without urticaria; allergy-related edema/angioedema) (4)
    CL Item
    Grad 4 (anaphylaxis) (5)
    Item Group
    Verfassung
    Item
    Fieber
    integer
    C0015967 (UMLS CUI [1])
    Code List
    Fieber
    CL Item
    Grade 0 (none) (1)
    CL Item
    Grade 1 (38.0-39.0 °C) (2)
    CL Item
    Grade 2 (39.1-40.0 °C) (3)
    CL Item
    Grade 3 (>40.0 °C for <24 hrs) (4)
    CL Item
    Grade 4 (>40.0 °C for >24 hrs) (5)
    Item
    Schüttelfrost
    integer
    C0036973 (UMLS CUI [1])
    Code List
    Schüttelfrost
    CL Item
    Grade 0 (none) (1)
    CL Item
    Grade 1 (mild, requiring symptomatic treatment (e.g., blanket) or non-narcotic medication) (2)
    CL Item
    Grade 2 (severe and/or prolonged, requiring narcotic medication) (3)
    CL Item
    Grade 3 (not responsive to narcotic medication) (4)
    CL Item
    Grade 4 (-) (5)
    Item Group
    Haut
    Item
    Ausschlag
    integer
    C0015230 (UMLS CUI [1])
    Code List
    Ausschlag
    CL Item
    Grade 0 (none) (1)
    CL Item
    Grade 1 (macular or papular eruption or erythema without associated symptoms) (2)
    CL Item
    Grade 2 (macular or papular eruption or erythema with pruritus or other associated symptoms covering <50% of body surface or localized desquamation or other lesions covering <50% of body surface area) (3)
    CL Item
    Grade 3 (symptomatic generalized erythroderma or macular, papular or vesicular eruption or desquamation covering ≥50% of body surface area) (4)
    CL Item
    Grade 4 (generalized exfoliative dermatitis or ulcerative dermatitis) (5)
    Item
    Nesselausschlag
    integer
    C0042109 (UMLS CUI [1])
    Code List
    Nesselausschlag
    CL Item
    Grade 0 (none) (1)
    CL Item
    Grade 1 (requiring no medication) (2)
    CL Item
    Grade 2 (requiring PO or topical treatment or IV medication or steroids for <24 hrs) (3)
    CL Item
    Grade 3 (requiring IV medication or steroids for ≥24 hrs) (4)
    CL Item
    Grade 4 (-) (5)
    Item Group
    Magen-Darm
    Item
    Übelkeit
    integer
    C0027497 (UMLS CUI [1])
    Code List
    Übelkeit
    CL Item
    Grade 0 (none) (1)
    CL Item
    Grade 1 (able to eat) (2)
    CL Item
    Grade 2 (oral intake significantly decreased) (3)
    CL Item
    Grade 3 (no significant intake, requiring IV fluids) (4)
    CL Item
    Grade 4 (-) (5)
    Item
    Erbrechen
    integer
    C0042963 (UMLS CUI [1])
    Code List
    Erbrechen
    CL Item
    Grade 0 (none) (1)
    CL Item
    Grade 1 (1 episode in 24 hours over pretreatment) (2)
    CL Item
    Grade 2 (2-5 episodes in 24 hours over pretreatment) (3)
    CL Item
    Grade 3 (≥6 episodes in 24 hours over pretreatment; or need for IV fluids) (4)
    CL Item
    Grade 4 (requiring parenteral nutrition; or physiologic consequences requiring intensive care; hemodynamic collapse) (5)
    Item Group
    Leber
    Item
    Alkalische Phosphatase
    integer
    C0002059 (UMLS CUI [1])
    Code List
    Alkalische Phosphatase
    CL Item
    Grade 0 (WNL) (1)
    CL Item
    Grade 1 (>ULN - 2.5 x ULN) (2)
    CL Item
    Grade 2 (>2.5 - 5.0 x ULN) (3)
    CL Item
    Grade 3 (>5.0 - 20.0 x ULN) (4)
    CL Item
    Grade 4 (>20.0 x ULN) (5)
    Item
    Bilirubin
    integer
    C0201913 (UMLS CUI [1])
    Code List
    Bilirubin
    CL Item
    Grade 0 (WNL) (1)
    CL Item
    Grade 1 (>ULN - 1.5 x ULN) (2)
    CL Item
    Grade 2 (>1.5 - 3.0 x ULN) (3)
    CL Item
    Grade 3 (>3.0 - 10.0 x ULN) (4)
    CL Item
    Grade 4 (>10.0 x ULN) (5)
    Item
    SGOT
    integer
    C0201899 (UMLS CUI [1])
    Code List
    SGOT
    CL Item
    Grade 0 (WNL) (1)
    CL Item
    Grade 1 (>ULN - 2.5 x ULN) (2)
    CL Item
    Grade 2 (>2.5 - 5.0 x ULN) (3)
    CL Item
    Grade 3 (>5.0 - 20.0 x ULN) (4)
    CL Item
    Grade 4 (>20.0 x ULN) (5)
    Item
    SGPT
    integer
    C0001899 (UMLS CUI [1])
    Code List
    SGPT
    CL Item
    Grade 0 (WNL) (1)
    CL Item
    Grade 1 (>ULN - 2.5 x ULN) (2)
    CL Item
    Grade 2 (>2.5 - 5.0 x ULN) (3)
    CL Item
    Grade 3 (>5.0 - 20.0 x ULN) (4)
    CL Item
    Grade 4 (>20.0 x ULN) (5)
    Item Group
    Metabolisch / Labor
    Item
    Übersäuerung
    integer
    C0001122 (UMLS CUI [1])
    Code List
    Übersäuerung
    CL Item
    Grade 0 (normal) (1)
    CL Item
    Grade 1 (pH <normal, but ≥7.3) (2)
    CL Item
    Grade 2 (-) (3)
    CL Item
    Grade 3 (pH <7.3) (4)
    CL Item
    Grade 4 (pH <7.3 with lifethreatening physiologic consequences) (5)
    Item
    Amylase
    integer
    C0201883 (UMLS CUI [1])
    Code List
    Amylase
    CL Item
    Grade 0 (WNL) (1)
    CL Item
    Grade 1 (>ULN - 1.5 x ULN) (2)
    CL Item
    Grade 2 (>1.5 - 2.0 x ULN) (3)
    CL Item
    Grade 3 (>2.0 - 5.0 x ULN) (4)
    CL Item
    Grade 4 (>5.0 x ULN) (5)
    Item
    Hypokaliämie
    integer
    C0020621 (UMLS CUI [1])
    Code List
    Hypokaliämie
    CL Item
    Grade 0 (WNL) (1)
    CL Item
    Grade 1 (<LLN - 3.0 mmol/L) (2)
    CL Item
    Grade 2 (-) (3)
    CL Item
    Grade 3 (2.5 - <3.0 mmol/L) (4)
    CL Item
    Grade 4 (<2.5 mmol/L) (5)
    Item
    Hypomagnesiämie
    integer
    C0151723 (UMLS CUI [1])
    Code List
    Hypomagnesiämie
    CL Item
    Grade 0 (WNL) (1)
    CL Item
    Grade 1 (<LLN - 1.2 mg/dL; <LLN - 0.5 mmol/L) (2)
    CL Item
    Grade 2 (0.9 - <1.2 mg/dL; 0.4 - <0.5 mmol/L) (3)
    CL Item
    Grade 3 (0.7 - <0.9 mg/dL; 0.3 - <0.4 mmol/L) (4)
    CL Item
    Grade 4 (<0.7 mg/dL; <0.3 mmol/L) (5)
    Item
    Lipase
    integer
    C0023764 (UMLS CUI [1])
    Code List
    Lipase
    CL Item
    Grade 0 (WNL) (1)
    CL Item
    Grade 1 (>ULN - 1.5 x ULN) (2)
    CL Item
    Grade 2 (>1.5 - 2.0 x ULN) (3)
    CL Item
    Grade 3 (>2.0 - 5.0 x ULN) (4)
    CL Item
    Grade 4 (>5.0 x ULN) (5)
    Item Group
    Lungen
    Item
    Dyspnoe
    integer
    C0013404 (UMLS CUI [1])
    Code List
    Dyspnoe
    CL Item
    Grade 0 (normal) (1)
    CL Item
    Grade 1 (-) (2)
    CL Item
    Grade 2 (dyspnea on exertion) (3)
    CL Item
    Grade 3 (dyspnea at normal level of activity) (4)
    CL Item
    Grade 4 (dyspnea at rest or requiring ventilator support) (5)
    Item Group
    Schmerz
    Item
    Bauchschmerzen
    integer
    C0000737 (UMLS CUI [1])
    Code List
    Bauchschmerzen
    CL Item
    Grade 0 (none) (1)
    CL Item
    Grade 1 (mild pain not interfering with function) (2)
    CL Item
    Grade 2 (moderate pain: pain or analgesics interfering with function, but not interfering with activities of daily living) (3)
    CL Item
    Grade 3 (severe pain: pain or analgesics severely interfering with activities of daily living) (4)
    CL Item
    Grade 4 (disabling) (5)
    Item
    Brustschmerz
    integer
    C0008031 (UMLS CUI [1])
    Code List
    Brustschmerz
    CL Item
    Grade 0 (none) (1)
    CL Item
    Grade 1 (mild pain not interfering with function) (2)
    CL Item
    Grade 2 (moderate pain: pain or analgesics interfering with function, but not interfering with activities of daily living) (3)
    CL Item
    Grade 3 (severe pain: pain or analgesics severely interfering with activities of daily living) (4)
    CL Item
    Grade 4 (disabling) (5)
    Item
    Kopfschmerz
    integer
    C0018681 (UMLS CUI [1])
    Code List
    Kopfschmerz
    CL Item
    Grade 0 (none) (1)
    CL Item
    Grade 1 (mild pain not interfering with function) (2)
    CL Item
    Grade 2 (moderate pain: pain or analgesics interfering with function, but not interfering with activities of daily living) (3)
    CL Item
    Grade 3 (severe pain: pain or analgesics severely interfering with activities of daily living) (4)
    CL Item
    Grade 4 (disabling) (5)
    Item
    Myalgie
    integer
    C0231528 (UMLS CUI [1])
    Code List
    Myalgie
    CL Item
    Grade 0 (none) (1)
    CL Item
    Grade 1 (mild pain not interfering with function) (2)
    CL Item
    Grade 2 (moderate pain: pain or analgesics interfering with function, but not interfering with activities of daily living) (3)
    CL Item
    Grade 3 (severe pain: pain or analgesics severely interfering with activities of daily living) (4)
    CL Item
    Grade 4 (disabling) (5)
    Item Group
    Renal / Genitourinary
    Item
    Kreatinin
    integer
    C0010294 (UMLS CUI [1])
    Code List
    Kreatinin
    CL Item
    Grade 0 (WNL) (1)
    CL Item
    Grade 1 (>ULN - 1.5 x ULN) (2)
    CL Item
    Grade 2 (>1.5 - 3.0 x ULN) (3)
    CL Item
    Grade 3 (>3.0 - 6.0 x ULN) (4)
    CL Item
    Grade 4 (>6.0 x ULN) (5)
    Item
    Nierenversagen
    integer
    C0035078 (UMLS CUI [1])
    Code List
    Nierenversagen
    CL Item
    Grade 0 (none) (1)
    CL Item
    Grade 1 (-) (2)
    CL Item
    Grade 2 (-) (3)
    CL Item
    Grade 3 (requiring dialysis, but reversible) (4)
    CL Item
    Grade 4 (requiring dialysis and irreversible) (5)
    Item Group
    Anhang VI: BMT-Komplex
    Item
    Abstoßung des Transplantats (graft failure)
    integer
    C2242642 (UMLS CUI [1])
    Code List
    Abstoßung des Transplantats (graft failure)
    CL Item
    Grade 0 (absent) (1)
    CL Item
    Grade 1 (mild) (2)
    CL Item
    Grade 2 (moderate) (3)
    CL Item
    Grade 3 (severe) (4)
    CL Item
    Grade 4 (life-threatening) (5)
    Item
    GVHD
    integer
    C0018133 (UMLS CUI [1])
    Code List
    GVHD
    CL Item
    Grade 0 (absent) (1)
    CL Item
    Grade 1 (mild) (2)
    CL Item
    Grade 2 (moderate) (3)
    CL Item
    Grade 3 (severe) (4)
    CL Item
    Grade 4 (life-threatening) (5)
    Item
    Venenverschlusskrankheit
    integer
    C0948441 (UMLS CUI [1])
    Code List
    Venenverschlusskrankheit
    CL Item
    Grade 0 (absent) (1)
    CL Item
    Grade 1 (mild) (2)
    CL Item
    Grade 2 (moderate) (3)
    CL Item
    Grade 3 (severe) (4)
    CL Item
    Grade 4 (life-threatening) (5)

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