ID

12632

Description

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

Keywords

  1. 11/10/15 11/10/15 -
  2. 11/11/15 11/11/15 -
  3. 12/7/15 12/7/15 -
Uploaded on

December 7, 2015

DOI

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License

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
Description

Allergien

Allergische Reaktionen / Überempfindlichkeit
Description

Allergic reaction / hypersensitivity

Data type

integer

Alias
UMLS CUI [1]
C0020517
Verfassung
Description

Verfassung

Fieber
Description

Fever

Data type

integer

Alias
UMLS CUI [1]
C0015967
Schüttelfrost
Description

Rigors, chills

Data type

integer

Alias
UMLS CUI [1]
C0036973
Haut
Description

Haut

Ausschlag
Description

Rash

Data type

integer

Alias
UMLS CUI [1]
C0015230
Nesselausschlag
Description

Urticaria

Data type

integer

Alias
UMLS CUI [1]
C0042109
Magen-Darm
Description

Magen-Darm

Übelkeit
Description

Nausea

Data type

integer

Alias
UMLS CUI [1]
C0027497
Erbrechen
Description

Vomiting

Data type

integer

Alias
UMLS CUI [1]
C0042963
Leber
Description

Leber

Alkalische Phosphatase
Description

Alkaline Phosphatase

Data type

integer

Alias
UMLS CUI [1]
C0002059
Bilirubin
Description

Bilirubin, total measurement

Data type

integer

Alias
UMLS CUI [1]
C0201913
SGOT
Description

SGOT

Data type

integer

Alias
UMLS CUI [1]
C0201899
SGPT
Description

SGPT

Data type

integer

Alias
UMLS CUI [1]
C0001899
Metabolisch / Labor
Description

Metabolisch / Labor

Übersäuerung
Description

Acidosis

Data type

integer

Alias
UMLS CUI [1]
C0001122
Amylase
Description

Amylase

Data type

integer

Alias
UMLS CUI [1]
C0201883
Hypokaliämie
Description

Hypokalemia

Data type

integer

Alias
UMLS CUI [1]
C0020621
Hypomagnesiämie
Description

Hypomagnesemia

Data type

integer

Alias
UMLS CUI [1]
C0151723
Lipase
Description

Lipase

Data type

integer

Alias
UMLS CUI [1]
C0023764
Lungen
Description

Lungen

Dyspnoe
Description

Dyspnea

Data type

integer

Alias
UMLS CUI [1]
C0013404
Schmerz
Description

Schmerz

Bauchschmerzen
Description

Abdominal pain

Data type

integer

Alias
UMLS CUI [1]
C0000737
Brustschmerz
Description

Chest pain

Data type

integer

Alias
UMLS CUI [1]
C0008031
Kopfschmerz
Description

Headache

Data type

integer

Alias
UMLS CUI [1]
C0018681
Myalgie
Description

Myalgia

Data type

integer

Alias
UMLS CUI [1]
C0231528
Renal / Genitourinary
Description

Renal / Genitourinary

Kreatinin
Description

Creatinine

Data type

integer

Alias
UMLS CUI [1]
C0010294
Nierenversagen
Description

Kidney Failure

Data type

integer

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

Anhang VI: BMT-Komplex

Abstoßung des Transplantats (graft failure)
Description

Engraft failure

Data type

integer

Alias
UMLS CUI [1]
C2242642
GVHD
Description

GVHD

Data type

integer

Alias
UMLS CUI [1]
C0018133
Venenverschlusskrankheit
Description

Venoocclusive disease

Data type

integer

Alias
UMLS CUI [1]
C0948441

Similar models

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

Name
Type
Description | Question | Decode (Coded Value)
Data type
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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