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ID
12372
Description
A Study of Caspofungin, Liposomal Amphotericin B or the Combination of Both for Patients After Stem-Cell Transplantation NCT00148148
Keywords
Versions (3)
- 11/10/15 11/10/15 -
- 11/11/15 11/11/15 -
- 12/7/15 12/7/15 -
Uploaded on
November 11, 2015
DOI
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License
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
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Day of last Dose-Toxicity Stem-Cell Transplantation CASLAMB NCT00148148
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)