Baseline-Toxicity Stem-Cell Transplantation CASLAMB NCT00148148

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StudyEvent: ODM
1. Baseline-Toxicity Stem-Cell Transplantation CASLAMB NCT00148148

Name

Typ

Description | Question | Decode (Coded Value)

Datentyp

Alias

Hypersensitivity

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)

Patient condition

Item Group

Patient condition

Fever

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)

Shivering

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)

Skin

Item Group

Skin

Exanthema

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)

Urticaria

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)

Gastrointestinal

Item Group

Gastrointestinal

Nausea

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)

Vomiting

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)

Hepatic

Item Group

Hepatic

Alkaline Phosphatase

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)

Bilirubin, total measurement

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)

Aspartate aminotransferase measurement

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)

Alanine Transaminase

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)

Metabolic/Laboratory

Item Group

Metabolic/Laboratory

Hyperchlorhydria

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)

Amylase measurement

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)

Hypokalemia

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)

Hypomagnesemia

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)

Lipase

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)

Pulmonary

Item Group

Pulmonary

Dyspnea

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)

Pain

Item Group

Pain

Abdominal 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)

Chest pain

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)

Headache

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)

Myalgia

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)

Renal/Genitourinary

Item Group

Renal/Genitourinary

Creatinine

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)

Kidney Failure

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)

Appendix VI: BMT complex

Item Group

Appendix VI: BMT complex

Engraft failure

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)

Graft-vs-Host Disease

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)

Venoocclusive disease

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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Baseline-Toxicity Stem-Cell Transplantation CASLAMB NCT00148148