Laboratory Examination - Treatment Period 2, Day 14, Pre-dose

1 forms

StudyEvent: ODM
1. Laboratory Examination - Treatment Period 2, Day 14, Pre-dose

Pregnancy Test

Description

Pregnancy Test

Alias

UMLS CUI-1: C0032976

Pregnancy Test: Date sample taken

Description

Complete for Female Subjects Only.

Data type

date

Alias

UMLS CUI [1,1]: C0032976

UMLS CUI [1,2]: C0011008

Pregnancy Test Results

Description

Pregnancy Test Results

Data type

text

Alias

UMLS CUI [1,1]: C0032976

UMLS CUI [1,2]: C1274040

Positive (Positive)

Negative (Negative)

Haematology

Description

Haematology

Alias

UMLS CUI-1: C0018941

Haematology: Date and time sample taken

Description

Day Month Year Hr : Min (00:00 - 23:59)

Data type

datetime

Alias

UMLS CUI [1,1]: C0005834

UMLS CUI [1,2]: C0011008

UMLS CUI [1,3]: C0040223

Has the subject fasted?

Description

Fasting

Data type

text

Alias

UMLS CUI [1]: C0015663

yes (y)

no (n)

White blood cell count (WBC) (absolute)

Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias

UMLS CUI [1]: C0023508

Red blood cell count (RBC) (absolute)

Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias

UMLS CUI [1]: C0014772

Haemoglobin (Hb)

Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias

UMLS CUI [1]: C0518015

Haematocrit (HCT)

Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias

UMLS CUI [1]: C0018935

Mean cell volume (MCV)

Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias

UMLS CUI [1]: C1948043

Mean cell haemoglobin (MCH)

Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias

UMLS CUI [1]: C0369183

Mean cell haemoglobin concentration (MCHC)

Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias

UMLS CUI [1]: C0474535

Platelet count (absolute)

Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias

UMLS CUI [1]: C0005821

Reticulocytes (absolute)

Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias

UMLS CUI [1]: C0206161

Neutrophil count (absolute)

Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias

UMLS CUI [1]: C0948762

Lymphocyte count

Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias

UMLS CUI [1]: C0200635

Monocyte count (absolute)

Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias

UMLS CUI [1]: C0750880

Eosinophil count (absolute)

Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias

UMLS CUI [1]: C0200638

Basophil count (absolute)

Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias

UMLS CUI [1]: C1883362

Clinical Chemistry

Description

Clinical Chemistry

Alias

UMLS CUI-1: C0008000

Date and time sample taken

Description

Date and time sample taken

Data type

datetime

Alias

UMLS CUI [1,1]: C0011008

UMLS CUI [1,2]: C0040223

UMLS CUI [1,3]: C0200345

Has the subject fasted?

Description

Fasting

Data type

text

Alias

UMLS CUI [1]: C0015663

yes (y)

no (n)

Alkaline phasphatase

Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias

UMLS CUI [1]: C0201850

Alanine transaminase

Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias

UMLS CUI [1]: C0201836

Aspartate transaminase

Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias

UMLS CUI [1]: C0004002

Gamma-glutamyl transpeptidase

Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias

UMLS CUI [1]: C0202035

Lactate dehydrogenase

Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias

UMLS CUI [1]: C0202113

Urea

Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias

UMLS CUI [1]: C0523961

Sodium

Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias

UMLS CUI [1]: C0337443

Triglycerides

Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias

UMLS CUI [1]: C0202236

Albumin

Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias

UMLS CUI [1]: C0201838

Total protein

Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias

UMLS CUI [1]: C0555903

Total Bilirubin

Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias

UMLS CUI [1]: C0201913

Creatinine

Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias

UMLS CUI [1]: C0201975

Potassium

Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias

UMLS CUI [1]: C0202194

Glucose

Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias

UMLS CUI [1]: C0337438

Cholesterol

Description

Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

Data type

text

Alias

UMLS CUI [1]: C0201950

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Laboratory Examination - Treatment Period 2, Day 14, Pre-dose

1 forms

StudyEvent: ODM
1. Laboratory Examination - Treatment Period 2, Day 14, Pre-dose

Name

Type

Description | Question | Decode (Coded Value)

Data type

Alias

Pregnancy Test

Item Group

Pregnancy Test

C0032976 (UMLS CUI-1)

Pregnancy test Date

Item

Pregnancy Test: Date sample taken

date

C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])

Pregnancy Test Results

Item

Pregnancy Test Results

text

C0032976 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])

Pregnancy Test Results

Code List

Pregnancy Test Results

CL Item

Positive (Positive)

CL Item

Negative (Negative)

Haematology

Item Group

Haematology

C0018941 (UMLS CUI-1)

Haematology sampling date and time

Item

Haematology: Date and time sample taken

datetime

C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])

Fasting

Item

Has the subject fasted?

text

C0015663 (UMLS CUI [1])

Fasting

Code List

Has the subject fasted?

CL Item

yes (y)

CL Item

no (n)

White blood cell count

Item

White blood cell count (WBC) (absolute)

text

C0023508 (UMLS CUI [1])

Red blood cell count

Item

Red blood cell count (RBC) (absolute)

text

C0014772 (UMLS CUI [1])

Haemoglobin

Item

Haemoglobin (Hb)

text

C0518015 (UMLS CUI [1])

Haematocrit

Item

Haematocrit (HCT)

text

C0018935 (UMLS CUI [1])

Mean cell volume

Item

Mean cell volume (MCV)

text

C1948043 (UMLS CUI [1])

Mean cell haemoglobin

Item

Mean cell haemoglobin (MCH)

text

C0369183 (UMLS CUI [1])

Mean cell haemoglobin concentration

Item

Mean cell haemoglobin concentration (MCHC)

text

C0474535 (UMLS CUI [1])

Platelet count

Item

Platelet count (absolute)

text

C0005821 (UMLS CUI [1])

Reticulocytes

Item

Reticulocytes (absolute)

text

C0206161 (UMLS CUI [1])

Neutrophil count

Item

Neutrophil count (absolute)

text

C0948762 (UMLS CUI [1])

Lymphocyte count

Item

Lymphocyte count

text

C0200635 (UMLS CUI [1])

Monocyte count

Item

Monocyte count (absolute)

text

C0750880 (UMLS CUI [1])

Eosinophil count

Item

Eosinophil count (absolute)

text

C0200638 (UMLS CUI [1])

Basophil count

Item

Basophil count (absolute)

text

C1883362 (UMLS CUI [1])

Clinical Chemistry

Item Group

Clinical Chemistry

C0008000 (UMLS CUI-1)

Date and time sample taken

Item

Date and time sample taken

datetime

C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])

Fasting

Item

Has the subject fasted?

text

C0015663 (UMLS CUI [1])

Fasting

Code List

Has the subject fasted?

CL Item

yes (y)

CL Item

no (n)

Alkaline phosphatase

Item

Alkaline phasphatase

text

C0201850 (UMLS CUI [1])

Alanine transaminase

Item

Alanine transaminase

text

C0201836 (UMLS CUI [1])

Aspartate transaminase

Item

Aspartate transaminase

text

C0004002 (UMLS CUI [1])

Gamma-glutamyl transpeptidase

Item

Gamma-glutamyl transpeptidase

text

C0202035 (UMLS CUI [1])

Lactate dehydrogenase

Item

Lactate dehydrogenase

text

C0202113 (UMLS CUI [1])

Urea

Item

Urea

text

C0523961 (UMLS CUI [1])

Sodium

Item

Sodium

text

C0337443 (UMLS CUI [1])

Triglycerides

Item

Triglycerides

text

C0202236 (UMLS CUI [1])

Albumin

Item

Albumin

text

C0201838 (UMLS CUI [1])

Total protein

Item

Total protein

text

C0555903 (UMLS CUI [1])

Total Bilirubin

Item

Total Bilirubin

text

C0201913 (UMLS CUI [1])

Creatinine

Item

Creatinine

text

C0201975 (UMLS CUI [1])

Potassium

Item

Potassium

text

C0202194 (UMLS CUI [1])

Glucose

Item

Glucose

text

C0337438 (UMLS CUI [1])

Cholesterol

Item

Cholesterol

text

C0201950 (UMLS CUI [1])

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