ID

12633

Descripción

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

Palabras clave

Versiones (4)
  1. 21/11/15 21/11/15 -
  2. 26/11/15 26/11/15 -
  3. 6/12/15 6/12/15 -
  4. 7/12/15 7/12/15 -
Subido en

7 de diciembre de 2015

DOI

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Licencia

Creative Commons BY-NC 3.0
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Baseline-Toxicity Stem-Cell Transplantation CASLAMB NCT00148148

Alemán Inglés

Baseline-Toxicity Stem-Cell Transplantation CASLAMB NCT00148148

1 formularios  
Hypersensitivity
Descripción

Hypersensitivity

Hypersensitivity
Descripción

Hypersensitivity

Tipo de datos

integer

Alias
UMLS CUI [1]
C0020517
Patient condition
Descripción

Patient condition

Fever
Descripción

Fever

Tipo de datos

integer

Unidades de medida
  • °C
Alias
UMLS CUI [1]
C0015967
Shivering
Descripción

Shivering

Tipo de datos

integer

Alias
UMLS CUI [1]
C0036973
Skin
Descripción

Skin

Exanthema
Descripción

Exanthema

Tipo de datos

integer

Alias
UMLS CUI [1]
C0015230
Urticaria
Descripción

Urticaria

Tipo de datos

integer

Alias
UMLS CUI [1]
C0042109
Gastrointestinal
Descripción

Gastrointestinal

Nausea
Descripción

Nausea

Tipo de datos

integer

Alias
UMLS CUI [1]
C0027497
Vomiting
Descripción

Vomiting

Tipo de datos

integer

Alias
UMLS CUI [1]
C0042963
Hepatic
Descripción

Hepatic

Alkaline Phosphatase
Descripción

Alkaline Phosphatase

Tipo de datos

integer

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

Bilirubin, total measurement

Tipo de datos

integer

Alias
UMLS CUI [1]
C0201913
Aspartate aminotransferase measurement
Descripción

Aspartate aminotransferase measurement

Tipo de datos

integer

Alias
UMLS CUI [1]
C0201899
Alanine Transaminase
Descripción

Alanine Transaminase

Tipo de datos

integer

Alias
UMLS CUI [1]
C0001899
Metabolic/Laboratory
Descripción

Metabolic/Laboratory

Hyperchlorhydria
Descripción

Hyperchlorhydria

Tipo de datos

integer

Alias
UMLS CUI [1]
C0151713
Amylase measurement
Descripción

Amylase measurement

Tipo de datos

integer

Alias
UMLS CUI [1]
C0201883
Hypokalemia
Descripción

Hypokalemia

Tipo de datos

integer

Alias
UMLS CUI [1]
C0020621
Hypomagnesemia
Descripción

Hypomagnesemia

Tipo de datos

integer

Alias
UMLS CUI [1]
C0151723
Lipase
Descripción

Lipase

Tipo de datos

integer

Alias
UMLS CUI [1]
C0023764
Pulmonary
Descripción

Pulmonary

Dyspnea
Descripción

Dyspnea

Tipo de datos

integer

Alias
UMLS CUI [1]
C0013404
Pain
Descripción

Pain

Abdominal pain
Descripción

Abdominal pain

Tipo de datos

integer

Alias
UMLS CUI [1]
C0000737
Chest pain
Descripción

Chest pain

Tipo de datos

integer

Alias
UMLS CUI [1]
C0008031
Headache
Descripción

Headache

Tipo de datos

integer

Alias
UMLS CUI [1]
C0018681
Myalgie
Descripción

Myalgia

Tipo de datos

integer

Alias
UMLS CUI [1]
C0231528
Renal/Genitourinary
Descripción

Renal/Genitourinary

Kreatinin
Descripción

Creatinine

Tipo de datos

integer

Alias
UMLS CUI [1]
C0010294
Kidney Failure
Descripción

Kidney Failure

Tipo de datos

integer

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

Appendix VI: BMT complex

Engraft failure
Descripción

Engraft failure

Tipo de datos

integer

Alias
UMLS CUI [1]
C2242642
Graft-vs-Host Disease
Descripción

Graft-vs-Host Disease

Tipo de datos

integer

Alias
UMLS CUI [1]
C0018133
Venoocclusive disease
Descripción

Venoocclusive disease

Tipo de datos

integer

Alias
UMLS CUI [1]
C0948441
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Similar models

Baseline-Toxicity Stem-Cell Transplantation CASLAMB NCT00148148

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Hypersensitivity
Item
Hypersensitivity
integer
C0020517 (UMLS CUI [1])
Allergic reaction / hypersensitivity
Code List
Hypersensitivity
CL Item
Grad 0 (none) (1)
C1827485 (UMLS CUI-1)
CL Item
Grade 1 (transient rash, drug fever <38C) (2)
C1560128 (UMLS CUI-1)
CL Item
Grade 2 (urticaria, drug fever 38 °C, and/or asymptomatic bronchospasm) (3)
C1560129 (UMLS CUI-1)
CL Item
Grade 3 (symptomatic bronchospasm, requiring parenteral medication/s, with or without urticaria; allergy-related edema/angioedema) (4)
C1560128 (UMLS CUI-1)
CL Item
Grade 4 (anaphylaxis) (5)
C1560131 (UMLS CUI-1)
Item Group
Patient condition
Item
integer
C0015967 (UMLS CUI [1])
Fever
Code List
Fever
CL Item
Grade 0 (none) (1)
C1827485 (UMLS CUI-1)
CL Item
Grade 1 (38.0-39.0 °C) (2)
C1556367 (UMLS CUI-1)
CL Item
Grade 2 (39.1-40.0 °C) (3)
C1556368 (UMLS CUI-1)
CL Item
Grade 3 (>40.0 °C for <24 hrs) (4)
C1556369 (UMLS CUI-1)
CL Item
Grade 4 (>40.0 °C for >24 hrs) (5)
C1556370 (UMLS CUI-1)
Item
integer
C0036973 (UMLS CUI [1])
Rigors, chills
Code List
Shivering
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
CL Item
 (4)
CL Item
 (5)
Item Group
Skin
Item
Exanthema
integer
C0015230 (UMLS CUI [1])
Rash
Code List
Exanthema
CL Item
Grade 0 (none) (1)
C1827485 (UMLS CUI-1)
CL Item
Grade 1 (macular or papular eruption or erythema without associated symptoms) (2)
C1827085 (UMLS CUI-1)
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)
C1827397 (UMLS CUI-1)
CL Item
Grade 3 (symptomatic generalized erythroderma or macular, papular or vesicular eruption or desquamation covering ≥50% of body surface area) (4)
C1827891 (UMLS CUI-1)
CL Item
Grade 4 (generalized exfoliative dermatitis or ulcerative dermatitis) (5)
C1827323 (UMLS CUI-1)
Item
Urticaria
integer
C0042109 (UMLS CUI [1])
Urticaria
Code List
Urticaria
CL Item
Grade 0 (none) (1)
C1827485 (UMLS CUI-1)
CL Item
Grade 1 (requiring no medication) (2)
C1827485 (UMLS CUI-1)
CL Item
Grade 2 (requiring PO or topical treatment or IV medication or steroids for <24 hrs) (3)
C1827397 (UMLS CUI-1)
CL Item
Grade 3 (requiring IV medication or steroids for ≥24 hrs) (4)
C1827891 (UMLS CUI-1)
CL Item
Grade 4 (-) (5)
C1827323 (UMLS CUI-1)
Item Group
Gastrointestinal
Item
Nausea
integer
C0027497 (UMLS CUI [1])
Nausea
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])
Vomiting
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])
Alkaline Phosphatase
Code List
Alkaline Phosphatase
CL Item
Grade 0 (WNL) (1)
CL Item
Grade 1 (>ULN - 2.5 x ULN) (2)
C1557180 (UMLS CUI-1)
CL Item
Grade 2 (>2.5 - 5.0 x ULN) (3)
C1557181 (UMLS CUI-1)
CL Item
Grade 3 (>5.0 - 20.0 x ULN) (4)
C1557182 (UMLS CUI-1)
CL Item
Grade 4 (>20.0 x ULN) (5)
C1557183 (UMLS CUI-1)
Item
Bilirubin, total measurement
integer
C0201913 (UMLS CUI [1])
Bilirubin
Code List
Bilirubin, total measurement
CL Item
Grade 0 (WNL) (1)
CL Item
Grade 1 (>ULN - 1.5 x ULN) (2)
C1557210 (UMLS CUI-1)
CL Item
Grade 2 (>1.5 - 3.0 x ULN) (3)
C1557211 (UMLS CUI-1)
CL Item
Grade 3 (>3.0 - 10.0 x ULN) (4)
C1557212 (UMLS CUI-1)
CL Item
Grade 4 (>10.0 x ULN) (5)
C1557213 (UMLS CUI-1)
Item
Aspartate aminotransferase measurement
integer
C0201899 (UMLS CUI [1])
SGOT
Code List
Aspartate aminotransferase measurement
CL Item
Grad 0 (WNL) (1)
CL Item
Grad 1 (>ULN - 2.5 x ULN) (2)
C1557199 (UMLS CUI-1)
CL Item
Grad 2 (>2.5 - 5.0 x ULN) (3)
C1557199 (UMLS CUI-1)
CL Item
Grad 3 (>5.0 - 20.0 x ULN) (4)
C1557201 (UMLS CUI-1)
CL Item
Grad 4 (>20.0 x ULN) (5)
C1557202 (UMLS CUI-1)
Item
Alanine Transaminase
integer
C0001899 (UMLS CUI [1])
SGPT
Code List
Alanine Transaminase
CL Item
Grad 0 (WNL) (1)
CL Item
Grad 1 (>ULN - 2.5 x ULN) (2)
C1557190 (UMLS CUI-1)
CL Item
Grad 2 (>2.5 - 5.0 x ULN) (3)
C1557191 (UMLS CUI-1)
CL Item
Grad 3 (>5.0 - 20.0 x ULN) (4)
C1557192 (UMLS CUI-1)
CL Item
Grad 4 (>20.0 x ULN) (5)
C1557193 (UMLS CUI-1)
Item Group
Metabolic/Laboratory
Item
Hyperchlorhydria
integer
C0151713 (UMLS CUI [1])
Acidosis
Code List
Hyperchlorhydria
CL Item
Grade 0 (normal) (1)
C0860760 (UMLS CUI-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 measurement
integer
C0201883 (UMLS CUI [1])
Amylase
Code List
Amylase measurement
CL Item
Grade 0 (WNL) (1)
CL Item
Grade 1 (>ULN - 1.5 x ULN) (2)
C1557194 (UMLS CUI-1)
CL Item
Grade 2 (>1.5 - 2.0 x ULN) (3)
C1557195 (UMLS CUI-1)
CL Item
Grade 3 (>2.0 - 5.0 x ULN) (4)
C1557196 (UMLS CUI-1)
CL Item
Grade 4 (>5.0 x ULN) (5)
C1557197 (UMLS CUI-1)
Item
Hypokalemia
integer
C0020621 (UMLS CUI [1])
Hypokalemia
Code List
Hypokalemia
CL Item
Grade 0 (WNL) (1)
CL Item
Grade 1 (<LLN - 3.0 mmol/L) (2)
C1559964 (UMLS CUI-1)
CL Item
Grade 2 (-) (3)
C1559965 (UMLS CUI-1)
CL Item
Grade 3 (2.5 - <3.0 mmol/L) (4)
C1559966 (UMLS CUI-1)
CL Item
Grade 4 (<2.5 mmol/L) (5)
C1559967 (UMLS CUI-1)
Item
Hypomagnesemia
integer
C0151723 (UMLS CUI [1])
Hypomagnesemia
Code List
Hypomagnesemia
CL Item
Grad 0 (WNL) (1)
CL Item
Grade 1 (<LLN - 1.2 mg/dL; <LLN - 0.5 mmol/L) (2)
C1559940 (UMLS CUI-1)
CL Item
Grade 2 (0.9 - <1.2 mg/dL; 0.4 - <0.5 mmol/L) (3)
C1559941 (UMLS CUI-1)
CL Item
Grade 3 (0.7 - <0.9 mg/dL; 0.3 - <0.4 mmol/L) (4)
C1559942 (UMLS CUI-1)
CL Item
Grade 4 (<0.7 mg/dL; <0.3 mmol/L) (5)
C1559943 (UMLS CUI-1)
Item
Lipase
integer
C0023764 (UMLS CUI [1])
Lipase
Code List
Lipase
CL Item
Grad 0 (WNL) (1)
CL Item
Grade 1 (>ULN - 1.5 x ULN) (2)
C1559930 (UMLS CUI-1)
CL Item
Grade 2 (>1.5 - 2.0 x ULN) (3)
C1559931 (UMLS CUI-1)
CL Item
Grade 3 (>2.0 - 5.0 x ULN) (4)
C1559932 (UMLS CUI-1)
CL Item
Grade 4 (>5.0 x ULN) (5)
C1559933 (UMLS CUI-1)
Item Group
Pulmonary
Item
Dyspnea
integer
C0013404 (UMLS CUI [1])
Dyspnea
Code List
Dyspnea
CL Item
Grade 0 (normal) (1)
CL Item
Grade 1 (-) (2)
C1557662 (UMLS CUI-1)
CL Item
Grade 2 (dyspnea on exertion) (3)
C1557663 (UMLS CUI-1)
CL Item
Grade 3 (dyspnea at normal level of activity) (4)
C1557664 (UMLS CUI-1)
CL Item
Grade 4 (dyspnea at rest or requiring ventilator support) (5)
C1557665 (UMLS CUI-1)
Item Group
Pain
Item
Abdominal pain
integer
C0000737 (UMLS CUI [1])
Abdominal pain
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])
Chest pain
Code List
Chest pain
CL Item
Grad 0 (none) (1)
CL Item
Grad 1 (mild pain not interfering with function) (2)
C1557431 (UMLS CUI-1)
CL Item
Grad 2 (moderate pain: pain or analgesics interfering with function, but not interfering with activities of daily living) (3)
C1557432 (UMLS CUI-1)
CL Item
Grad 3 (severe pain: pain or analgesics severely interfering with activities of daily living) (4)
C1557433 (UMLS CUI-1)
CL Item
Grad 4 (disabling) (5)
C1557434 (UMLS CUI-1)
Item
Headache
integer
C0018681 (UMLS CUI [1])
Headache
Code List
Headache
CL Item
Grad 0 (none) (1)
CL Item
Grad 1 (mild pain not interfering with function) (2)
C1557471 (UMLS CUI-1)
CL Item
Grad 2 (moderate pain: pain or analgesics interfering with function, but not interfering with activities of daily living) (3)
C1557472 (UMLS CUI-1)
CL Item
Grad 3 (severe pain: pain or analgesics severely interfering with activities of daily living) (4)
C1557473 (UMLS CUI-1)
CL Item
Grad 4 (disabling) (5)
C1557474 (UMLS CUI-1)
Item
Myalgie
integer
C0231528 (UMLS CUI [1])
Myalgia
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])
Creatinine
Code List
Kreatinin
CL Item
Grade 0 (WNL) (1)
CL Item
Grade 1 (>ULN - 1.5 x ULN) (2)
C1559901 (UMLS CUI-1)
CL Item
Grade 2 (>1.5 - 3.0 x ULN) (3)
C1559902 (UMLS CUI-1)
CL Item
Grade 3 (>3.0 - 6.0 x ULN) (4)
C1559903 (UMLS CUI-1)
CL Item
Grade 4 (>6.0 x ULN) (5)
C1559904 (UMLS CUI-1)
Item
Kidney Failure
integer
C0035078 (UMLS CUI [1])
Renal failure
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])
Failure to engraft
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
Graft-vs-Host Disease
integer
C0018133 (UMLS CUI [1])
Failure to engraft
Code List
Graft-vs-Host 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)
Item
Venoocclusive disease
integer
C0948441 (UMLS CUI [1])
Failure to engraft
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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