ID

28338

Beschreibung

NCT02499003 The GOAL Trial: Rescue Treatment With the Monoclonal Anti CD20-antibody Obinutuzumab (GA101) in Combination With Pixantrone for the Treatment of Patients With Relapsed Aggressive B-cell Lymphoma Source: Prof. Dr. med. Georg Heß Universitätsmedizin Mainz

Stichworte

Versionen (3)
  1. 04.12.17 04.12.17 -
  2. 04.12.17 04.12.17 -
  3. 04.01.18 04.01.18 -
Rechteinhaber

Prof. Dr. med. Georg Heß

Hochgeladen am

4. Januar 2018

DOI

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Lizenz

Creative Commons BY-NC 3.0
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    Laboratory GOAL Trial B-cell Lymphoma NCT02499003

    Englisch

    Laboratory GOAL Trial B-cell Lymphoma NCT02499003

    1 Formulare  
    Admininstrative data
    Beschreibung

    Admininstrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject ID
    Beschreibung

    Subject ID

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    Visit
    Beschreibung

    Visit

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0545082
    Laboratory: Hematology
    Beschreibung

    Laboratory: Hematology

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C0474523
    Date
    Beschreibung

    Date

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C0011008
    Hematocrit: Lab value
    Beschreibung

    Hematocrit

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0518014
    Hematocrit: Unit
    Beschreibung

    Hematocrit unit

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0518014
    UMLS CUI [1,2]
    C1519795
    Hematocrit: Clin. significant?
    Beschreibung

    clinical significance

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2826293
    Hematocrit: CTCAE
    Beschreibung

    CTCAE

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1516728
    Hemoglobin: Lab value
    Beschreibung

    Hemoglobin

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0518015
    Hemoglobin: Unit
    Beschreibung

    Hemoglobin unit

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1519795
    UMLS CUI [1,2]
    C0518015
    Hemoglobin: Clin. significant?
    Beschreibung

    clinical significance

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2826293
    Hemoglobin: CTCAE
    Beschreibung

    CTCAE

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1516728
    Red blood cells: Lab value
    Beschreibung

    Red blood cells

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0014772
    Red blood cells: Unit
    Beschreibung

    Red blood cells unit

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0014772
    UMLS CUI [1,2]
    C1519795
    Red blood cells: Clin. significant?
    Beschreibung

    clinical significance

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2826293
    Red blood cells: CTCAE
    Beschreibung

    CTCAE

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1516728
    White blood cells: Lab value
    Beschreibung

    White blood cells

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0023508
    White blood cells: Unit
    Beschreibung

    White blood cells unit

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0023508
    UMLS CUI [1,2]
    C1519795
    White blood cells: Clin. significant?
    Beschreibung

    clinical significance

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2826293
    White blood cells: CTCAE
    Beschreibung

    CTCAE

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1516728
    Platelets: Lab value
    Beschreibung

    Platelets

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0032181
    Platelets: Unit
    Beschreibung

    Platelets unit

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0032181
    UMLS CUI [1,2]
    C1519795
    Platelets: Clin. significant?
    Beschreibung

    clinical significance

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2826293
    Platelets: CTCAE
    Beschreibung

    CTCAE

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1516728
    Neutrophils: Lab value
    Beschreibung

    Neutrophils

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0200633
    Neutrophils: Unit
    Beschreibung

    Neutrophils unit

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0200633
    UMLS CUI [1,2]
    C1519795
    Neutrophils: Clin. significant?
    Beschreibung

    clinical significance

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2826293
    Neutrophils: CTCAE
    Beschreibung

    CTCAE

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1516728
    Eosinophils: Lab value
    Beschreibung

    Eosinophils

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0200638
    Eosinophils: Unit
    Beschreibung

    Eosinophils unit

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0200638
    UMLS CUI [1,2]
    C1519795
    Eosinophils: Clin. significant?
    Beschreibung

    clinical significance

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2826293
    Eosinophils: CTCAE
    Beschreibung

    CTCAE

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1516728
    Basophils: Lab value
    Beschreibung

    Basophils

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0200641
    Basophils: Unit
    Beschreibung

    Basophils unit

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0200641
    UMLS CUI [1,2]
    C1519795
    Basophils: Clin. significant?
    Beschreibung

    clinical significance

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2826293
    Basophils: CTCAE
    Beschreibung

    CTCAE

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1516728
    Monocytes: Lab value
    Beschreibung

    Monocytes

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0200637
    Monocytes: Unit
    Beschreibung

    Monocytes unit

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0200637
    UMLS CUI [1,2]
    C1519795
    Monocytes: Clin. significant?
    Beschreibung

    clinical significance

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2826293
    Monocytes: CTCAE
    Beschreibung

    CTCAE

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1516728
    Lymphocytes: Lab value
    Beschreibung

    Lymphocytes

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0200635
    Lymphocytes: Unit
    Beschreibung

    Lymphocytes unit

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0200635
    UMLS CUI [1,2]
    C1519795
    Lymphocytes: Clin. significant?
    Beschreibung

    clinical significance

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2826293
    Lymphocytes: CTCAE
    Beschreibung

    CTCAE

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1516728
    ANC: Lab value
    Beschreibung

    ANC

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0948762
    ANC: Unit
    Beschreibung

    ANC unit

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0948762
    UMLS CUI [1,2]
    C1519795
    ANC: Clin. significant?
    Beschreibung

    clinical significance

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2826293
    ANC: CTCAE
    Beschreibung

    CTCAE

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1516728
    Laboratory: Blood chemistry
    Beschreibung

    Laboratory: Blood chemistry

    Alias
    UMLS CUI-1
    C1254595
    UMLS CUI-2
    C0005774
    Sodium: Lab value
    Beschreibung

    Sodium

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0337443
    Sodium: Unit
    Beschreibung

    Sodium unit

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0337443
    UMLS CUI [1,2]
    C1519795
    Sodium: Clin. significant?
    Beschreibung

    clinical significance

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2826293
    Sodium: CTCAE
    Beschreibung

    CTCAE

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1516728
    Potassium: Lab value
    Beschreibung

    Potassium

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0202194
    Potassium: Unit
    Beschreibung

    Potassium unit

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0202194
    UMLS CUI [1,2]
    C1519795
    Potassium: Clin. significant?
    Beschreibung

    clinical significance

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2826293
    Potassium: CTCAE
    Beschreibung

    CTCAE

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1516728
    Calcium: Lab value
    Beschreibung

    Calcium

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0201925
    Calcium: Unit
    Beschreibung

    Calcium unit

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0201925
    UMLS CUI [1,2]
    C1519795
    Calcium: Clin. significant?
    Beschreibung

    clinical significance

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2826293
    Calcium: CTCAE
    Beschreibung

    CTCAE

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1516728
    Chloride: Lab value
    Beschreibung

    Chloride

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0201952
    Chloride: Unit
    Beschreibung

    Chloride unit

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0201952
    UMLS CUI [1,2]
    C1519795
    Chloride: Clin. significant?
    Beschreibung

    clinical significance

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2826293
    Chloride: CTCAE
    Beschreibung

    CTCAE

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1516728
    Magnesium: Lab value
    Beschreibung

    Magnesium

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0373675
    Magnesium: Unit
    Beschreibung

    Magnesium unit

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0373675
    UMLS CUI [1,2]
    C1519795
    Magnesium: Clin. significant?
    Beschreibung

    clinical significance

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2826293
    Magnesium: CTCAE
    Beschreibung

    CTCAE

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1516728
    Bilirubin (total): Lab value
    Beschreibung

    Bilirubin

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1278039
    Bilirubin (total): Unit
    Beschreibung

    Bilirubin unit

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1278039
    UMLS CUI [1,2]
    C1519795
    Bilirubin (total): Clin. significant?
    Beschreibung

    clinical significance

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2826293
    Bilirubin: CTCAE
    Beschreibung

    CTCAE

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1516728
    AST (GOT): Lab value
    Beschreibung

    AST GOT

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0201899
    AST (GOT): Unit
    Beschreibung

    AST GOT unit

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0201899
    UMLS CUI [1,2]
    C1519795
    AST (GOT): Clin. significant?
    Beschreibung

    clinical significance

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2826293
    AST (GOT): CTCAE
    Beschreibung

    CTCAE

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1516728
    ALT (GPT): Lab value
    Beschreibung

    ALT GPT

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0201836
    ALT (GPT): Unit
    Beschreibung

    ALT GPT unit

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0201836
    UMLS CUI [1,2]
    C1519795
    ALT (GPT): Clin. significant?
    Beschreibung

    clinical significance

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2826293
    ALT (GPT): CTCAE
    Beschreibung

    CTCAE

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1516728
    GGT: Lab value
    Beschreibung

    GGT

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0202035
    GGT: Unit
    Beschreibung

    GGT unit

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0202035
    UMLS CUI [1,2]
    C1519795
    GGT: Clin. significant?
    Beschreibung

    clinical significance

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2826293
    GGT: CTCAE
    Beschreibung

    CTCAE

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1516728
    Lipase: Lab value
    Beschreibung

    Lipase

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0373670
    Lipase: Unit
    Beschreibung

    Lipase unit

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0373670
    UMLS CUI [1,2]
    C1519795
    Lipase: Clin. significant?
    Beschreibung

    clinical significance

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2826293
    Lipase: CTCAE
    Beschreibung

    CTCAE

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1516728
    Amylase: Lab value
    Beschreibung

    Amylase

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0201883
    Amylase: Unit
    Beschreibung

    Amylase unit

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0201883
    UMLS CUI [1,2]
    C1519795
    Amylase: Clin. significant?
    Beschreibung

    clinical significance

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2826293
    Amylase: CTCAE
    Beschreibung

    CTCAE

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1516728
    Creatinine: Lab value
    Beschreibung

    Creatinine

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0201976
    Creatinine: Unit
    Beschreibung

    Creatinine unit

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0201976
    UMLS CUI [1,2]
    C1519795
    Creatinine: Clin. significant?
    Beschreibung

    clinical significance

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2826293
    Creatinine: CTCAE
    Beschreibung

    CTCAE

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1516728
    Uric acid: Lab value
    Beschreibung

    Uric acid

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0041980
    Uric acid: Unit
    Beschreibung

    Uric acid unit

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0041980
    UMLS CUI [1,2]
    C1519795
    Uric acid: Clin. significant?
    Beschreibung

    clinical significance

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2826293
    Uric acid: CTCAE
    Beschreibung

    CTCAE

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1516728
    Troponin T: Lab value
    Beschreibung

    Troponin T or Troponin I

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0585642
    Troponin T: Unit
    Beschreibung

    Troponin T or Troponin I

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0585642
    UMLS CUI [1,2]
    C1519795
    Troponin T: Clin. significant?
    Beschreibung

    Troponin T or Troponin I

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2826293
    Troponin T: CTCAE
    Beschreibung

    Troponin T or Troponin I

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1516728
    Troponin I: Lab value
    Beschreibung

    Troponin T or Troponin I

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0920210
    Troponin I: Unit
    Beschreibung

    Troponin T or Troponin I

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0920210
    UMLS CUI [1,2]
    C1519795
    Troponin I: Clin. significant?
    Beschreibung

    Troponin T or Troponin I

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2826293
    Troponin I: CTCAE
    Beschreibung

    Troponin T or Troponin I

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1516728
    LDH: Lab value
    Beschreibung

    This item applies to the following visits: Day 1 of Cycles 1 - 6; Day 22 of Cycles 2 - 6; Interim Staging; End of Treatment; Follow Up 1 - 8.

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0202113
    LDH: Unit
    Beschreibung

    This item applies to the following visits: Day 1 of Cycles 1 - 6; Day 22 of Cycles 2 - 6; Interim Staging; End of Treatment; Follow Up 1 - 8.

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0202113
    UMLS CUI [1,2]
    C1519795
    LDH: Clin. significant?
    Beschreibung

    This item applies to the following visits: Day 1 of Cycles 1 - 6; Day 22 of Cycles 2 - 6; Interim Staging; End of Treatment; Follow Up 1 - 8.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2826293
    LDH: CTCAE
    Beschreibung

    This item applies to the following visits: Day 1 of Cycles 1 - 6; Day 22 of Cycles 2 - 6; Interim Staging; End of Treatment; Follow Up 1 - 8.

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1516728
    BNP: Lab value
    Beschreibung

    BNP or NT-ProBNP. This item applies to the following visits: Days 8, 15, and 22 of Cycle 1; Day 1 of Cycles 2 - 6; Interim Staging; End of Treatment; Follow Up 1 - 8.

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1095989
    BNP: Unit
    Beschreibung

    BNP or NT-ProBNP. This item applies to the following visits: Days 8, 15, and 22 of Cycle 1; Day 1 of Cycles 2 - 6; Interim Staging; End of Treatment; Follow Up 1 - 8.

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1095989
    UMLS CUI [1,2]
    C1519795
    BNP: Clin. significant?
    Beschreibung

    BNP or NT-ProBNP. This item applies to the following visits: Days 8, 15, and 22 of Cycle 1; Day 1 of Cycles 2 - 6; Interim Staging; End of Treatment; Follow Up 1 - 8.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2826293
    BNP: CTCAE
    Beschreibung

    BNP or NT-ProBNP. This item applies to the following visits: Days 8, 15, and 22 of Cycle 1; Day 1 of Cycles 2 - 6; Interim Staging; End of Treatment; Follow Up 1 - 8.

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1516728
    NT-ProBNP: Lab value
    Beschreibung

    BNP or NT-ProBNP. This item applies to the following visits: Days 8, 15, and 22 of Cycle 1; Day 1 of Cycles 2 - 6; Interim Staging; End of Treatment; Follow Up 1 - 8.

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C3272900
    NT-ProBNP: Unit
    Beschreibung

    BNP or NT-ProBNP. This item applies to the following visits: Days 8, 15, and 22 of Cycle 1; Day 1 of Cycles 2 - 6; Interim Staging; End of Treatment; Follow Up 1 - 8.

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C3272900
    UMLS CUI [1,2]
    C1519795
    NT-ProBNP: Clin. significant?
    Beschreibung

    BNP or NT-ProBNP. This item applies to the following visits: Days 8, 15, and 22 of Cycle 1; Day 1 of Cycles 2 - 6; Interim Staging; End of Treatment; Follow Up 1 - 8.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2826293
    NT-ProBNP: CTCAE
    Beschreibung

    BNP or NT-ProBNP. This item applies to the following visits: Days 8, 15, and 22 of Cycle 1; Day 1 of Cycles 2 - 6; Interim Staging; End of Treatment; Follow Up 1 - 8.

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1516728
    sCD25: Lab value
    Beschreibung

    This item applies to the following visits: Cycle 1 Day 1, Interim Staging, and Follow Up 1 - 8.

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C3888514
    sCD25: Unit
    Beschreibung

    This item applies to the following visits: Cycle 1 Day 1, Interim Staging, and Follow Up 1 - 8.

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C3888514
    UMLS CUI [1,2]
    C1519795
    sCD25: Clin. significant?
    Beschreibung

    This item applies to the following visits: Cycle 1 Day 1, Interim Staging, and Follow Up 1 - 8.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2826293
    sCD25: CTCAE
    Beschreibung

    This item applies to the following visits: Cycle 1 Day 1, Interim Staging, and Follow Up 1 - 8.

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1516728
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    Ähnliche Modelle

    Laboratory GOAL Trial B-cell Lymphoma NCT02499003

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Admininstrative data
    C1320722 (UMLS CUI-1)
    Subject ID
    Item
    Subject ID
    text
    C2348585 (UMLS CUI [1])
    Item
    Visit
    text
    C0545082 (UMLS CUI [1])
    Visit
    Code List
    Visit
    CL Item
    Cycle 1 Day 1 (Cycle 1 Day 1)
    CL Item
    Cycle 1 Day 15 (Cycle 1 Day 15)
    CL Item
    Cycle 1 Day 22 (Cycle 1 Day 22)
    CL Item
    Cycle 2 Day 1 (Cycle 2 Day 1)
    CL Item
    Cycle 2 Day 8 (Cycle 2 Day 8)
    CL Item
    Cycle 2 Day 15 (Cycle 2 Day 15)
    CL Item
    Cycle 2 Day 22 (Cycle 2 Day 22)
    CL Item
    Cycle 3 Day 1 (Cycle 3 Day 1)
    CL Item
    Cycle 3 Day 8 (Cycle 3 Day 8)
    CL Item
    Cycle 3 Day 15 (Cycle 3 Day 15)
    CL Item
    Cycle 3 Day 22 (Cycle 3 Day 22)
    CL Item
    Interim Staging (Interim Staging)
    CL Item
    Cycle 4 Day 1 (Cycle 4 Day 1)
    CL Item
    Cycle 4 Day 8 (Cycle 4 Day 8)
    CL Item
    Cycle 4 Day 15 (Cycle 4 Day 15)
    CL Item
    Cycle 4 Day 22 (Cycle 4 Day 22)
    CL Item
    Cycle 5 Day 1 (Cycle 5 Day 1)
    CL Item
    Cycle 5 Day 8 (Cycle 5 Day 8)
    CL Item
    Cycle 5 Day 15 (Cycle 5 Day 15)
    CL Item
    Cycle 5 Day 22 (Cycle 5 Day 22)
    CL Item
    Cycle 6 Day 1 (Cycle 6 Day 1)
    CL Item
    Cycle 6 Day 8 (Cycle 6 Day 8)
    CL Item
    Cycle 6 Day 15 (Cycle 6 Day 15)
    CL Item
    Cycle 6 Day 22 (Cycle 6 Day 22)
    CL Item
    End of Treatment (End of Treatment)
    CL Item
    Follow Up 1 (Follow Up 1)
    CL Item
    Follow Up 2 (Follow Up 2)
    CL Item
    Follow Up 3 (Follow Up 3)
    CL Item
    Follow Up 4 (Follow Up 4)
    CL Item
    Follow Up 5 (Follow Up 5)
    CL Item
    Follow Up 6 (Follow Up 6)
    CL Item
    Follow Up 7 (Follow Up 7)
    CL Item
    Follow Up 8 (Follow Up 8)
    CL Item
    Cyce 1 Day 8 (Cycle 1 Day 8)
    Item Group
    Laboratory: Hematology
    C0022885 (UMLS CUI-1)
    C0474523 (UMLS CUI-2)
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
    Hematocrit
    Item
    Hematocrit: Lab value
    text
    C0518014 (UMLS CUI [1])
    Hematocrit unit
    Item
    Hematocrit: Unit
    text
    C0518014 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    clinical significance
    Item
    Hematocrit: Clin. significant?
    boolean
    C2826293 (UMLS CUI [1])
    CTCAE
    Item
    Hematocrit: CTCAE
    text
    C1516728 (UMLS CUI [1])
    Hemoglobin
    Item
    Hemoglobin: Lab value
    text
    C0518015 (UMLS CUI [1])
    Hemoglobin unit
    Item
    Hemoglobin: Unit
    text
    C1519795 (UMLS CUI [1,1])
    C0518015 (UMLS CUI [1,2])
    clinical significance
    Item
    Hemoglobin: Clin. significant?
    boolean
    C2826293 (UMLS CUI [1])
    CTCAE
    Item
    Hemoglobin: CTCAE
    text
    C1516728 (UMLS CUI [1])
    Red blood cells
    Item
    Red blood cells: Lab value
    text
    C0014772 (UMLS CUI [1])
    Red blood cells unit
    Item
    Red blood cells: Unit
    text
    C0014772 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    clinical significance
    Item
    Red blood cells: Clin. significant?
    boolean
    C2826293 (UMLS CUI [1])
    CTCAE
    Item
    Red blood cells: CTCAE
    text
    C1516728 (UMLS CUI [1])
    White blood cells
    Item
    White blood cells: Lab value
    text
    C0023508 (UMLS CUI [1])
    White blood cells unit
    Item
    White blood cells: Unit
    text
    C0023508 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    clinical significance
    Item
    White blood cells: Clin. significant?
    boolean
    C2826293 (UMLS CUI [1])
    CTCAE
    Item
    White blood cells: CTCAE
    text
    C1516728 (UMLS CUI [1])
    Platelets
    Item
    Platelets: Lab value
    text
    C0032181 (UMLS CUI [1])
    Platelets unit
    Item
    Platelets: Unit
    text
    C0032181 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    clinical significance
    Item
    Platelets: Clin. significant?
    boolean
    C2826293 (UMLS CUI [1])
    CTCAE
    Item
    Platelets: CTCAE
    text
    C1516728 (UMLS CUI [1])
    Neutrophils
    Item
    Neutrophils: Lab value
    text
    C0200633 (UMLS CUI [1])
    Neutrophils unit
    Item
    Neutrophils: Unit
    text
    C0200633 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    clinical significance
    Item
    Neutrophils: Clin. significant?
    boolean
    C2826293 (UMLS CUI [1])
    CTCAE
    Item
    Neutrophils: CTCAE
    text
    C1516728 (UMLS CUI [1])
    Eosinophils
    Item
    Eosinophils: Lab value
    text
    C0200638 (UMLS CUI [1])
    Eosinophils unit
    Item
    Eosinophils: Unit
    text
    C0200638 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    clinical significance
    Item
    Eosinophils: Clin. significant?
    boolean
    C2826293 (UMLS CUI [1])
    CTCAE
    Item
    Eosinophils: CTCAE
    text
    C1516728 (UMLS CUI [1])
    Basophils
    Item
    Basophils: Lab value
    text
    C0200641 (UMLS CUI [1])
    Basophils unit
    Item
    Basophils: Unit
    text
    C0200641 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    clinical significance
    Item
    Basophils: Clin. significant?
    boolean
    C2826293 (UMLS CUI [1])
    CTCAE
    Item
    Basophils: CTCAE
    text
    C1516728 (UMLS CUI [1])
    Monocytes
    Item
    Monocytes: Lab value
    text
    C0200637 (UMLS CUI [1])
    Monocytes unit
    Item
    Monocytes: Unit
    text
    C0200637 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    clinical significance
    Item
    Monocytes: Clin. significant?
    boolean
    C2826293 (UMLS CUI [1])
    CTCAE
    Item
    Monocytes: CTCAE
    text
    C1516728 (UMLS CUI [1])
    Lymphocytes
    Item
    Lymphocytes: Lab value
    text
    C0200635 (UMLS CUI [1])
    Lymphocytes unit
    Item
    Lymphocytes: Unit
    text
    C0200635 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    clinical significance
    Item
    Lymphocytes: Clin. significant?
    boolean
    C2826293 (UMLS CUI [1])
    CTCAE
    Item
    Lymphocytes: CTCAE
    text
    C1516728 (UMLS CUI [1])
    ANC
    Item
    ANC: Lab value
    text
    C0948762 (UMLS CUI [1])
    ANC unit
    Item
    ANC: Unit
    text
    C0948762 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    clinical significance
    Item
    ANC: Clin. significant?
    boolean
    C2826293 (UMLS CUI [1])
    CTCAE
    Item
    ANC: CTCAE
    text
    C1516728 (UMLS CUI [1])
    Item Group
    Laboratory: Blood chemistry
    C1254595 (UMLS CUI-1)
    C0005774 (UMLS CUI-2)
    Sodium
    Item
    Sodium: Lab value
    text
    C0337443 (UMLS CUI [1])
    Sodium unit
    Item
    Sodium: Unit
    text
    C0337443 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    clinical significance
    Item
    Sodium: Clin. significant?
    boolean
    C2826293 (UMLS CUI [1])
    CTCAE
    Item
    Sodium: CTCAE
    text
    C1516728 (UMLS CUI [1])
    Potassium
    Item
    Potassium: Lab value
    text
    C0202194 (UMLS CUI [1])
    Potassium unit
    Item
    Potassium: Unit
    text
    C0202194 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    clinical significance
    Item
    Potassium: Clin. significant?
    boolean
    C2826293 (UMLS CUI [1])
    CTCAE
    Item
    Potassium: CTCAE
    text
    C1516728 (UMLS CUI [1])
    Calcium
    Item
    Calcium: Lab value
    text
    C0201925 (UMLS CUI [1])
    Calcium unit
    Item
    Calcium: Unit
    text
    C0201925 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    clinical significance
    Item
    Calcium: Clin. significant?
    boolean
    C2826293 (UMLS CUI [1])
    CTCAE
    Item
    Calcium: CTCAE
    text
    C1516728 (UMLS CUI [1])
    Chloride
    Item
    Chloride: Lab value
    text
    C0201952 (UMLS CUI [1])
    Chloride unit
    Item
    Chloride: Unit
    text
    C0201952 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    clinical significance
    Item
    Chloride: Clin. significant?
    boolean
    C2826293 (UMLS CUI [1])
    CTCAE
    Item
    Chloride: CTCAE
    text
    C1516728 (UMLS CUI [1])
    Magnesium
    Item
    Magnesium: Lab value
    text
    C0373675 (UMLS CUI [1])
    Magnesium unit
    Item
    Magnesium: Unit
    text
    C0373675 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    clinical significance
    Item
    Magnesium: Clin. significant?
    boolean
    C2826293 (UMLS CUI [1])
    CTCAE
    Item
    Magnesium: CTCAE
    text
    C1516728 (UMLS CUI [1])
    Bilirubin
    Item
    Bilirubin (total): Lab value
    text
    C1278039 (UMLS CUI [1])
    Bilirubin unit
    Item
    Bilirubin (total): Unit
    text
    C1278039 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    clinical significance
    Item
    Bilirubin (total): Clin. significant?
    boolean
    C2826293 (UMLS CUI [1])
    CTCAE
    Item
    Bilirubin: CTCAE
    text
    C1516728 (UMLS CUI [1])
    AST GOT
    Item
    AST (GOT): Lab value
    text
    C0201899 (UMLS CUI [1])
    AST GOT unit
    Item
    AST (GOT): Unit
    text
    C0201899 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    clinical significance
    Item
    AST (GOT): Clin. significant?
    boolean
    C2826293 (UMLS CUI [1])
    CTCAE
    Item
    AST (GOT): CTCAE
    text
    C1516728 (UMLS CUI [1])
    ALT GPT
    Item
    ALT (GPT): Lab value
    text
    C0201836 (UMLS CUI [1])
    ALT GPT unit
    Item
    ALT (GPT): Unit
    text
    C0201836 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    clinical significance
    Item
    ALT (GPT): Clin. significant?
    boolean
    C2826293 (UMLS CUI [1])
    CTCAE
    Item
    ALT (GPT): CTCAE
    text
    C1516728 (UMLS CUI [1])
    GGT
    Item
    GGT: Lab value
    text
    C0202035 (UMLS CUI [1])
    GGT unit
    Item
    GGT: Unit
    text
    C0202035 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    clinical significance
    Item
    GGT: Clin. significant?
    boolean
    C2826293 (UMLS CUI [1])
    CTCAE
    Item
    GGT: CTCAE
    text
    C1516728 (UMLS CUI [1])
    Lipase
    Item
    Lipase: Lab value
    text
    C0373670 (UMLS CUI [1])
    Lipase unit
    Item
    Lipase: Unit
    text
    C0373670 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    clinical significance
    Item
    Lipase: Clin. significant?
    boolean
    C2826293 (UMLS CUI [1])
    CTCAE
    Item
    Lipase: CTCAE
    text
    C1516728 (UMLS CUI [1])
    Amylase
    Item
    Amylase: Lab value
    text
    C0201883 (UMLS CUI [1])
    Amylase unit
    Item
    Amylase: Unit
    text
    C0201883 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    clinical significance
    Item
    Amylase: Clin. significant?
    boolean
    C2826293 (UMLS CUI [1])
    CTCAE
    Item
    Amylase: CTCAE
    text
    C1516728 (UMLS CUI [1])
    Creatinine
    Item
    Creatinine: Lab value
    text
    C0201976 (UMLS CUI [1])
    Creatinine unit
    Item
    Creatinine: Unit
    text
    C0201976 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    clinical significance
    Item
    Creatinine: Clin. significant?
    boolean
    C2826293 (UMLS CUI [1])
    CTCAE
    Item
    Creatinine: CTCAE
    text
    C1516728 (UMLS CUI [1])
    Uric acid
    Item
    Uric acid: Lab value
    text
    C0041980 (UMLS CUI [1])
    Uric acid unit
    Item
    Uric acid: Unit
    text
    C0041980 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    clinical significance
    Item
    Uric acid: Clin. significant?
    boolean
    C2826293 (UMLS CUI [1])
    CTCAE
    Item
    Uric acid: CTCAE
    text
    C1516728 (UMLS CUI [1])
    Troponin T
    Item
    Troponin T: Lab value
    text
    C0585642 (UMLS CUI [1])
    Troponin T unit
    Item
    Troponin T: Unit
    text
    C0585642 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    clinical significance
    Item
    Troponin T: Clin. significant?
    boolean
    C2826293 (UMLS CUI [1])
    CTCAE
    Item
    Troponin T: CTCAE
    text
    C1516728 (UMLS CUI [1])
    Troponin I
    Item
    Troponin I: Lab value
    text
    C0920210 (UMLS CUI [1])
    Troponin I unit
    Item
    Troponin I: Unit
    text
    C0920210 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    clinical significance
    Item
    Troponin I: Clin. significant?
    boolean
    C2826293 (UMLS CUI [1])
    CTCAE
    Item
    Troponin I: CTCAE
    text
    C1516728 (UMLS CUI [1])
    LDH
    Item
    LDH: Lab value
    text
    C0202113 (UMLS CUI [1])
    LDH unit
    Item
    LDH: Unit
    text
    C0202113 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    clinical significance
    Item
    LDH: Clin. significant?
    boolean
    C2826293 (UMLS CUI [1])
    CTCAE
    Item
    LDH: CTCAE
    text
    C1516728 (UMLS CUI [1])
    BNP
    Item
    BNP: Lab value
    text
    C1095989 (UMLS CUI [1])
    BNP unit
    Item
    BNP: Unit
    text
    C1095989 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    clinical significance
    Item
    BNP: Clin. significant?
    boolean
    C2826293 (UMLS CUI [1])
    CTCAE
    Item
    BNP: CTCAE
    text
    C1516728 (UMLS CUI [1])
    NT-ProBNP
    Item
    NT-ProBNP: Lab value
    text
    C3272900 (UMLS CUI [1])
    NT-ProBNP unit
    Item
    NT-ProBNP: Unit
    text
    C3272900 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    clinical significance
    Item
    NT-ProBNP: Clin. significant?
    boolean
    C2826293 (UMLS CUI [1])
    CTCAE
    Item
    NT-ProBNP: CTCAE
    text
    C1516728 (UMLS CUI [1])
    sCD25
    Item
    sCD25: Lab value
    text
    C3888514 (UMLS CUI [1])
    sCD25 unit
    Item
    sCD25: Unit
    text
    C3888514 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    clinical significance
    Item
    sCD25: Clin. significant?
    boolean
    C2826293 (UMLS CUI [1])
    CTCAE
    Item
    sCD25: CTCAE
    text
    C1516728 (UMLS CUI [1])
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