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

To request one please log in.

License

Creative Commons BY-NC 3.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

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

Data type

integer

Alias
UMLS CUI [1]
C0020517
Patient condition
Description

Patient condition

Fever
Description

Fever

Data type

integer

Alias
UMLS CUI [1]
C0015967
Rigors, chills
Description

Rigors, chills

Data type

integer

Alias
UMLS CUI [1]
C0036973
Skin
Description

Skin

Rash
Description

Rash

Data type

integer

Alias
UMLS CUI [1]
C0015230
Urticaria
Description

Urticaria

Data type

integer

Alias
UMLS CUI [1]
C0042109
Gastrointestinal
Description

Gastrointestinal

Nausea
Description

Nausea

Data type

integer

Alias
UMLS CUI [1]
C0027497
Vomiting
Description

Vomiting

Data type

integer

Alias
UMLS CUI [1]
C0042963
Hepatic
Description

Hepatic

Alkaline Phosphatase
Description

Alkaline Phosphatase

Data type

integer

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

Metabolic / Laboratory

Acidosis
Description

Acidosis

Data type

integer

Alias
UMLS CUI [1]
C0001122
Amylase
Description

Amylase

Data type

integer

Alias
UMLS CUI [1]
C0201883
Hypokalemia
Description

Hypokalemia

Data type

integer

Alias
UMLS CUI [1]
C0020621
Hypomagnesemia
Description

Hypomagnesemia

Data type

integer

Alias
UMLS CUI [1]
C0151723
Lipase
Description

Lipase

Data type

integer

Alias
UMLS CUI [1]
C0023764
Pulmonary
Description

Pulmonary

Dyspnea
Description

Dyspnea

Data type

integer

Alias
UMLS CUI [1]
C0013404
Pain
Description

Pain

Abdominal pain
Description

Abdominal pain

Data type

integer

Alias
UMLS CUI [1]
C0000737
Chest pain
Description

Chest pain

Data type

integer

Alias
UMLS CUI [1]
C0008031
Headache
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

Creatinine
Description

Creatinine

Data type

integer

Alias
UMLS CUI [1]
C0010294
Kidney Failure
Description

Kidney Failure

Data type

integer

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

Appendix VI: BMT complex

Engraft failure
Description

Engraft failure

Data type

integer

Alias
UMLS CUI [1]
C2242642
GVHD
Description

GVHD

Data type

integer

Alias
UMLS CUI [1]
C0018133
Venoocclusive disease
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
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)

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial