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

1 moduli

StudyEvent: ODM
1. Day of last Dose-Toxicity Stem-Cell Transplantation CASLAMB NCT00148148

Name

genere

Description | Question | Decode (Coded Value)

Tipo di dati

Alias

Allergy

Item Group

Allergic reaction / hypersensitivity

Item

Allergische Reaktionen / Überempfindlichkeit

integer

Allergic reaction / hypersensitivity

Code List

Allergische Reaktionen / Überempfindlichkeit

CL Item

Grad 0 (none) (1)

CL Item

Grad 1 (transient rash, drug fever <38°C) (2)

CL Item

Grad 2 (urticaria, drug fever ≥38°C, 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)

Constitutional

Item Group

Verfassung

Fever

Item

Fieber

integer

Fever

Code List

Fieber

CL Item

Grad 0 (none) (1)

CL Item

Grad 1 (38.0-39.0 °C) (2)

CL Item

Grad 2 (39.1-40.0 °C) (3)

CL Item

Grad 3 (>40.0 °C for <24 hrs) (4)

CL Item

Grad 4 (>40.0 °C for >24 hrs) (5)

Rigors, chills

Item

Rigor, Schüttelfrost

integer

Rigors, chills

Code List

Rigor, Schüttelfrost

CL Item

Grad 0 (none) (1)

CL Item

Grad 1 (mild, requiring symptomatic treatment (e.g., blanket) or non-narcotic medication) (2)

CL Item

Grad 2 (severe and/or prolonged, requiring narcotic medication) (3)

CL Item

Grad 3 (not responsive to narcotic medication) (4)

CL Item

Grad 4 (-) (5)

Skin

Item Group

Haut

Rash

Item

Ausschlag

integer

Rash

Code List

Ausschlag

CL Item

Grad 0 (none) (1)

CL Item

Grad 1 (macular or papular eruption or erythema without associated symptoms) (2)

CL Item

Grad 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

Grad 3 (symptomatic generalized erythroderma or macular, papular or vesicular eruption or desquamation covering ≥50% of body surface area) (4)

CL Item

Grad 4 (generalized exfoliative dermatitis or ulcerative dermatitis) (5)

Urticaria

Item

Nesselausschlag

integer

Urticaria

Code List

Nesselausschlag

CL Item

Grad 0 (none) (1)

CL Item

Grad 1 (requiring no medication) (2)

CL Item

Grad 2 (requiring PO or topical treatment or IV medication or steroids for <24 hrs) (3)

CL Item

Grad 3 (requiring IV medication or steroids for ≥24 hrs) (4)

CL Item

Grad 4 (-) (5)

Gastrointestinal

Item Group

Magen-Darm

Nausea

Item

Übelkeit

integer

Nausea

Code List

Übelkeit

CL Item

Grad 0 (none) (1)

CL Item

Grad 1 (able to eat) (2)

CL Item

Grad 2 (oral intake significantly decreased) (3)

CL Item

Grad 3 (no significant intake, requiring IV fluids) (4)

CL Item

Grad 4 (-) (5)

Vomiting

Item

Erbrechen

integer

Vomiting

Code List

Erbrechen

CL Item

Grad 0 (none) (1)

CL Item

Grad 1 (1 episode in 24 hours over pretreatment) (2)

CL Item

Grad 2 (2-5 episodes in 24 hours over pretreatment) (3)

CL Item

Grad 3 (≥6 episodes in 24 hours over pretreatment; or need for IV fluids) (4)

CL Item

Grad 4 (requiring parenteral nutrition; or physiologic consequences requiring intensive care; hemodynamic collapse) (5)

Hepatic

Item Group

Leber

Alkaline Phosphatase

Item

Alkalische Phosphatase

integer

Alkaline Phosphatase

Code List

Alkalische Phosphatase

CL Item

Grad 0 (WNL) (1)

CL Item

Grad 1 (>ULN - 2.5 x ULN) (2)

CL Item

Grad 2 (>2.5 - 5.0 x ULN) (3)

CL Item

Grad 3 (>5.0 - 20.0 x ULN) (4)

CL Item

Grad 4 (>20.0 x ULN) (5)

Bilirubin

Item

Bilirubin

integer

Bilirubin

Code List

Bilirubin

CL Item

Grad 0 (WNL) (1)

CL Item

Grad 1 (>ULN - 1.5 x ULN) (2)

CL Item

Grad 2 (>1.5 - 3.0 x ULN) (3)

CL Item

Grad 3 (>3.0 - 10.0 x ULN) (4)

CL Item

Grad 4 (>10.0 x ULN) (5)

SGOT

Item

SGOT

integer

SGOT

Code List

SGOT

CL Item

Grad 0 (WNL) (1)

CL Item

Grad 1 (>ULN - 2.5 x ULN) (2)

CL Item

Grad 2 (>2.5 - 5.0 x ULN) (3)

CL Item

Grad 3 (>5.0 - 20.0 x ULN) (4)

CL Item

Grad 4 (>20.0 x ULN) (5)

SGPT

Item

SGPT

integer

SGPT

Code List

SGPT

CL Item

Grad 0 (WNL) (1)

CL Item

Grad 1 (>ULN - 2.5 x ULN) (2)

CL Item

Grad 2 (>2.5 - 5.0 x ULN) (3)

CL Item

Grad 3 (>5.0 - 20.0 x ULN) (4)

CL Item

Grad 4 (>20.0 x ULN) (5)

Metabolic/Laboratory

Item Group

Metabolic / Labor

Acidosis

Item

Übersäuerung

integer

Acidosis

Code List

Übersäuerung

CL Item

Grad 0 (normal) (1)

CL Item

Grad 1 (pH <normal, but ≥7.3) (2)

CL Item

Grad 2 (-) (3)

CL Item

Grad 3 (pH <7.3) (4)

CL Item

Grad 4 (pH <7.3 with lifethreatening physiologic consequences) (5)

Amylase

Item

Amylase

integer

Amylase

Code List

Amylase

CL Item

Grad 0 (WNL) (1)

CL Item

Grad 1 (>ULN - 1.5 x ULN) (2)

CL Item

Grad 2 (>1.5 - 2.0 x ULN) (3)

CL Item

Grad 3 (>2.0 - 5.0 x ULN) (4)

CL Item

Grad 4 (>5.0 x ULN) (5)

Hypokalemia

Item

Hypokaliämie

integer

Hypokalemia

Code List

Hypokaliämie

CL Item

Grad 0 (WNL) (1)

CL Item

Grad 1 (<LLN - 3.0 mmol/L) (2)

CL Item

Grad 2 (-) (3)

CL Item

Grad 3 (2.5 - <3.0 mmol/L) (4)

CL Item

Grad 4 (<2.5 mmol/L) (5)

Hypomagnesemia

Item

Hypomagnesiämie

integer

Hypomagnesemia

Code List

Hypomagnesiämie

CL Item

Grad 0 (WNL) (1)

CL Item

Grad 1 (<LLN - 1.2 mg/dL; <LLN - 0.5 mmol/L) (2)

CL Item

Grad 2 (0.9 - <1.2 mg/dL; 0.4 - <0.5 mmol/L) (3)

CL Item

Grad 3 (0.7 - <0.9 mg/dL; 0.3 - <0.4 mmol/L) (4)

CL Item

Grad 4 (<0.7 mg/dL; <0.3 mmol/L) (5)

Lipase

Item

Lipase

integer

Lipase

Code List

Lipase

CL Item

Grad 0 (WNL) (1)

CL Item

Grad 1 (>ULN - 1.5 x ULN) (2)

CL Item

Grad 2 (>1.5 - 2.0 x ULN) (3)

CL Item

Grad 3 (>2.0 - 5.0 x ULN) (4)

CL Item

Grad 4 (>5.0 x ULN) (5)

Pulmonary

Item Group

Lungen

Dyspnea

Item

Kurzatmigkeit

integer

Dyspnea

Code List

Kurzatmigkeit

CL Item

Grad 0 (normal) (1)

CL Item

Grad 1 (-) (2)

CL Item

Grad 2 (dyspnea on exertion) (3)

CL Item

Grad 3 (dyspnea at normal level of activity) (4)

CL Item

Grad 4 (dyspnea at rest or requiring ventilator support) (5)

Pain

Item Group

Schmerz

Abdominal pain

Item

Bauchschmerzen

integer

Abdominal pain

Code List

Bauchschmerzen

CL Item

Grad 0 (none) (1)

CL Item

Grad 1 (mild pain not interfering with function) (2)

CL Item

Grad 2 (moderate pain: pain or analgesics interfering with function, but not interfering with activities of daily living) (3)

CL Item

Grad 3 (severe pain: pain or analgesics severely interfering with activities of daily living) (4)

CL Item

Grad 4 (disabling) (5)

Chest pain

Item

Brustschmerz

integer

Chest pain

Code List

Brustschmerz

CL Item

Grad 0 (none) (1)

CL Item

Grad 1 (mild pain not interfering with function) (2)

CL Item

Grad 2 (moderate pain: pain or analgesics interfering with function, but not interfering with activities of daily living) (3)

CL Item

Grad 3 (severe pain: pain or analgesics severely interfering with activities of daily living) (4)

CL Item

Grad 4 (disabling) (5)

Headache

Item

Kopfschmerz

integer

Headache

Code List

Kopfschmerz

CL Item

Grad 0 (none) (1)

CL Item

Grad 1 (mild pain not interfering with function) (2)

CL Item

Grad 2 (moderate pain: pain or analgesics interfering with function, but not interfering with activities of daily living) (3)

CL Item

Grad 3 (severe pain: pain or analgesics severely interfering with activities of daily living) (4)

CL Item

Grad 4 (disabling) (5)

Myalgia

Item

Myalgie

integer

Myalgia

Code List

Myalgie

CL Item

Grad 0 (none) (1)

CL Item

Grad 1 (mild pain not interfering with function) (2)

CL Item

Grad 2 (moderate pain: pain or analgesics interfering with function, but not interfering with activities of daily living) (3)

CL Item

Grad 3 (severe pain: pain or analgesics severely interfering with activities of daily living) (4)

CL Item

Grad 4 (disabling) (5)

Renal/Genitourinary

Item Group

Renal / Genitourinary

Creatinine

Item

Kreatinin

integer

Creatinine

Code List

Kreatinin

CL Item

Grad 0 (WNL) (1)

CL Item

Grad 1 (>ULN - 1.5 x ULN) (2)

CL Item

Grad 2 (>1.5 - 3.0 x ULN) (3)

CL Item

Grad 3 (>3.0 - 6.0 x ULN) (4)

CL Item

Grad 4 (>6.0 x ULN) (5)

Renal failure

Item

Nierenversagen

integer

Renal failure

Code List

Nierenversagen

CL Item

Grad 0 (none) (1)

CL Item

Grad 1 (-) (2)

CL Item

Grad 2 (-) (3)

CL Item

Grad 3 (requiring dialysis, but reversible) (4)

CL Item

Grad 4 (requiring dialysis and irreversible) (5)

Appendix VI: BMT complex

Item Group

Anhang VI: BMT-Komplex

Failure to engraft

Item

Nichtbeachtung

integer

Failure to engraft

Code List

Nichtbeachtung

CL Item

Grad 0 (absent) (1)

CL Item

Grad 1 (mild) (2)

CL Item

Grad 2 (moderate) (3)

CL Item

Grad 3 (severe) (4)

CL Item

Grad 4 (life-threatening) (5)

GVHD

Item

GVHD

integer

Failure to engraft

Code List

GVHD

CL Item

Grad 0 (absent) (1)

CL Item

Grad 1 (mild) (2)

CL Item

Grad 2 (moderate) (3)

CL Item

Grad 3 (severe) (4)

CL Item

Grad 4 (life-threatening) (5)

Veno-occlusive disease

Item

Venenverschlusskrankheit

integer

Failure to engraft

Code List

Venenverschlusskrankheit

CL Item

Grad 0 (absent) (1)

CL Item

Grad 1 (mild) (2)

CL Item

Grad 2 (moderate) (3)

CL Item

Grad 3 (severe) (4)

CL Item

Grad 4 (life-threatening) (5)

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