ID

12632

Description

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

Mots-clés

  1. 10/11/2015 10/11/2015 -
  2. 11/11/2015 11/11/2015 -
  3. 07/12/2015 07/12/2015 -
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7 décembre 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

Allergy
Description

Allergy

Allergic reaction / hypersensitivity
Description

Allergic reaction / hypersensitivity

Type de données

integer

Alias
UMLS CUI [1]
C0020517
Patient condition
Description

Patient condition

Fever
Description

Fever

Type de données

integer

Alias
UMLS CUI [1]
C0015967
Rigors, chills
Description

Rigors, chills

Type de données

integer

Alias
UMLS CUI [1]
C0036973
Skin
Description

Skin

Rash
Description

Rash

Type de données

integer

Alias
UMLS CUI [1]
C0015230
Urticaria
Description

Urticaria

Type de données

integer

Alias
UMLS CUI [1]
C0042109
Gastrointestinal
Description

Gastrointestinal

Nausea
Description

Nausea

Type de données

integer

Alias
UMLS CUI [1]
C0027497
Vomiting
Description

Vomiting

Type de données

integer

Alias
UMLS CUI [1]
C0042963
Hepatic
Description

Hepatic

Alkaline Phosphatase
Description

Alkaline Phosphatase

Type de données

integer

Alias
UMLS CUI [1]
C0002059
Bilirubin, total measurement
Description

Bilirubin, total measurement

Type de données

integer

Alias
UMLS CUI [1]
C0201913
SGOT
Description

SGOT

Type de données

integer

Alias
UMLS CUI [1]
C0201899
SGPT
Description

SGPT

Type de données

integer

Alias
UMLS CUI [1]
C0001899
Metabolic / Laboratory
Description

Metabolic / Laboratory

Acidosis
Description

Acidosis

Type de données

integer

Alias
UMLS CUI [1]
C0001122
Amylase
Description

Amylase

Type de données

integer

Alias
UMLS CUI [1]
C0201883
Hypokalemia
Description

Hypokalemia

Type de données

integer

Alias
UMLS CUI [1]
C0020621
Hypomagnesemia
Description

Hypomagnesemia

Type de données

integer

Alias
UMLS CUI [1]
C0151723
Lipase
Description

Lipase

Type de données

integer

Alias
UMLS CUI [1]
C0023764
Pulmonary
Description

Pulmonary

Dyspnea
Description

Dyspnea

Type de données

integer

Alias
UMLS CUI [1]
C0013404
Pain
Description

Pain

Abdominal pain
Description

Abdominal pain

Type de données

integer

Alias
UMLS CUI [1]
C0000737
Chest pain
Description

Chest pain

Type de données

integer

Alias
UMLS CUI [1]
C0008031
Headache
Description

Headache

Type de données

integer

Alias
UMLS CUI [1]
C0018681
Myalgie
Description

Myalgia

Type de données

integer

Alias
UMLS CUI [1]
C0231528
Renal/Genitourinary
Description

Renal/Genitourinary

Creatinine
Description

Creatinine

Type de données

integer

Alias
UMLS CUI [1]
C0010294
Kidney Failure
Description

Kidney Failure

Type de données

integer

Alias
UMLS CUI [1]
C0035078
Appendix VI: BMT complex
Description

Appendix VI: BMT complex

Engraft failure
Description

Engraft failure

Type de données

integer

Alias
UMLS CUI [1]
C2242642
GVHD
Description

GVHD

Type de données

integer

Alias
UMLS CUI [1]
C0018133
Venoocclusive disease
Description

Venoocclusive disease

Type de données

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)
Type de données
Alias
Item Group
Allergy
Item
Allergic reaction / hypersensitivity
integer
C0020517 (UMLS CUI [1])
Code List
Allergic reaction / hypersensitivity
CL Item
Grade 0 (none) (1)
CL Item
Grade 1 (transient rash, drug fever <38C) (2)
CL Item
Grade 2 (urticaria, drug fever 38C, and/or asymptomatic bronchospasm) (3)
CL Item
Grade 3 (symptomatic bronchospasm, requiring parenteral medication/s, with or without urticaria; allergy-related edema/angioedema) (4)
CL Item
Grade 4 (anaphylaxis) (5)
Item Group
Patient condition
Item
Fever
integer
C0015967 (UMLS CUI [1])
Code List
Fever
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
Rigors, chills
integer
C0036973 (UMLS CUI [1])
Code List
Rigors, chills
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
Skin
Item
Rash
integer
C0015230 (UMLS CUI [1])
Code List
Rash
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
Urticaria
integer
C0042109 (UMLS CUI [1])
Code List
Urticaria
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
Gastrointestinal
Item
Nausea
integer
C0027497 (UMLS CUI [1])
Code List
Nausea
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
Vomiting
integer
C0042963 (UMLS CUI [1])
Code List
Vomiting
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
Hepatic
Item
Alkaline Phosphatase
integer
C0002059 (UMLS CUI [1])
Code List
Alkaline 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, total measurement
integer
C0201913 (UMLS CUI [1])
Code List
Bilirubin, total measurement
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
Metabolic / Laboratory
Item
Acidosis
integer
C0001122 (UMLS CUI [1])
Code List
Acidosis
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
Hypokalemia
integer
C0020621 (UMLS CUI [1])
Code List
Hypokalemia
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
Hypomagnesemia
integer
C0151723 (UMLS CUI [1])
Code List
Hypomagnesemia
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
Pulmonary
Item
Dyspnea
integer
C0013404 (UMLS CUI [1])
Code List
Dyspnea
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
Pain
Item
Abdominal pain
integer
C0000737 (UMLS CUI [1])
Code List
Abdominal pain
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
Chest pain
integer
C0008031 (UMLS CUI [1])
Code List
Chest pain
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
Headache
integer
C0018681 (UMLS CUI [1])
Code List
Headache
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
Creatinine
integer
C0010294 (UMLS CUI [1])
Code List
Creatinine
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
Kidney Failure
integer
C0035078 (UMLS CUI [1])
Code List
Kidney Failure
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
Appendix VI: BMT complex
Item
Engraft failure
integer
C2242642 (UMLS CUI [1])
Code List
Engraft 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
Venoocclusive disease
integer
C0948441 (UMLS CUI [1])
Code List
Venoocclusive disease
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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