Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item
Session number
text
C1883017 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
CL Item
1 (1)
(Comment:en)
CL Item
1.1 (1.1)
(Comment:en)
CL Item
2 (2)
(Comment:en)
CL Item
3 (3)
(Comment:en)
Item
Day number
integer
C0439228 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
CL Item
1 (1)
(Comment:en)
CL Item
7 (7)
(Comment:en)
CL Item
14 (14)
(Comment:en)
Lab code
Item
Lab code
text
C0022885 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Day hematology sample taken
Item
Day hematology sample taken
date
C0011008 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0474523 (UMLS CUI [1,3])
Time of sample
Item
Time of sample
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0474523 (UMLS CUI [1,3])
Clinically significant hematology abnormalities
Item
Were there any clinically significant hematology abnormalities?
boolean
C0474523 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,3])
Item
If YES, choose abnormal hematology parameter(s)
text
C0474523 (UMLS CUI [1,1])
C0549193 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C2985739 (UMLS CUI [1,4])
Code List
If YES, choose abnormal hematology parameter(s)
CL Item
Hemoglobin (Hemoglobin)
CL Item
Hematocrit (Hematocrit)
CL Item
Platelets (Platelets)
CL Item
Total WBC (Total WBC)
CL Item
Neutrophils (Neutrophils)
CL Item
Lymphocytes (Lymphocytes)
CL Item
Monocytes (Monocytes)
CL Item
Eosinophils (Eosinophils)
CL Item
Basophils (Basophils)
Item
Record primary reason for clinically significant hematology abnormality
text
C0474523 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,3])
C1549995 (UMLS CUI [1,4])
Code List
Record primary reason for clinically significant hematology abnormality
CL Item
Due to disease under study (D)
(Comment:en)
CL Item
Due to other concurrent disease (C)
(Comment:en)
CL Item
Reasonable possibility due to investigational product (T)
(Comment:en)
CL Item
Reasonable possibility due to other concomitant medication (M)
(Comment:en)
CL Item
Other, specify in the following item (X)
(Comment:en)
Primary reason for hematology abnormality
Item
If answer 'X' was choosen as primary reason, specify abnormality in hematology parameter
text
C0474523 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,3])
C1549995 (UMLS CUI [1,4])
Lab code
Item
Lab code
text
C0022885 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Day clinical chemistry sample taken
Item
Day clinical chemistry sample taken
date
C0011008 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,3])
Time of sample
Item
Time of sample
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,3])
Clinically significant clinical chemistry abnormalities
Item
Were there any clinically significant clinical chemistry abnormalities?
boolean
C0008000 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,3])
Item
If YES, choose abnormal clinical chemistry parameter(s)
text
C0008000 (UMLS CUI [1,1])
C0549193 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C2985739 (UMLS CUI [1,4])
Code List
If YES, choose abnormal clinical chemistry parameter(s)
CL Item
Potassium (Potassium)
CL Item
Chloride (Chloride)
CL Item
Calcium (Calcium)
CL Item
Glucose (Glucose)
CL Item
Creatinine (Creatinine)
CL Item
Total bilirubin (Total bilirubin)
CL Item
Alkaline Phosphatase (Alkaline Phosphatase)
CL Item
AST (SGOT) (AST (SGOT))
CL Item
ALT (SGPT) (ALT (SGPT))
CL Item
Troponin I (Troponin I)
Item
Record primary reason for clinical chemistry abnormality
text
C0008000 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,3])
C1549995 (UMLS CUI [1,4])
Code List
Record primary reason for clinical chemistry abnormality
CL Item
Due to disease under study (D)
(Comment:en)
CL Item
Due to other concurrent disease (C)
(Comment:en)
CL Item
Reasonable possibility due to investigational product (T)
(Comment:en)
CL Item
Reasonable possibility due to other concomitant medication (M)
(Comment:en)
CL Item
Other, specify in the following item (X)
(Comment:en)
Primary reason for clinical chemistry abnormality
Item
If answer 'X' was choosen as primary reason, specify abnormality in clinical chemistry parameter
text
C0008000 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,3])
C1549995 (UMLS CUI [1,4])
Day urinalysis sample taken
Item
Day urinalysis sample taken
date
C0011008 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0042014 (UMLS CUI [1,3])
Time of sample
Item
Time of sample
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0042014 (UMLS CUI [1,3])
Clinically significant urinalysis abnormalities
Item
Were there any clinically significant urinalysis abnormalities?
boolean
C0042014 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,3])
Item
If YES, choose abnormal dip-sticks parameter(s)
text
C0042014 (UMLS CUI [1,1])
C1160927 (UMLS CUI [1,2])
C0549193 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,4])
C2985739 (UMLS CUI [1,5])
Code List
If YES, choose abnormal dip-sticks parameter(s)
CL Item
Protein (Protein)
CL Item
Ketones (Ketones)
CL Item
Glucose (Glucose)
CL Item
Bilirubin (Bilirubin)
CL Item
Leucocytes (Leucocytes)
Item
Record primary reason for clinically significant urinalysis abnormality in dip-sticks
text
C0042014 (UMLS CUI [1,1])
C1160927 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C2985739 (UMLS CUI [1,4])
C1549995 (UMLS CUI [1,5])
Code List
Record primary reason for clinically significant urinalysis abnormality in dip-sticks
CL Item
Due to disease under study (D)
(Comment:en)
CL Item
Due to other concurrent disease (C)
(Comment:en)
CL Item
Reasonable possibility due to investigational product (T)
(Comment:en)
CL Item
Reasonable possibility due to other concomitant medication (M)
(Comment:en)
CL Item
Other, specify in the following item (X)
(Comment:en)
Primary reason for urinalysis abnormality in dip-sticks
Item
If answer 'X' was choosen as primary reason, specify abnormality in dip-sticks parameter
text
C0042014 (UMLS CUI [1,1])
C1160927 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C2985739 (UMLS CUI [1,4])
C1549995 (UMLS CUI [1,5])
Item
Choose abnormal urinalysis sedimentary microscopy parameter(s)
text
C2700128 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,3])
Code List
Choose abnormal urinalysis sedimentary microscopy parameter(s)
CL Item
Hyaline casts (Hyaline casts)
CL Item
Granular casts (Granular casts)
CL Item
Cellular casts (Cellular casts)
Item
Record primary reason for abnormality in sedimentary microscopy
text
C0042014 (UMLS CUI [1,1])
C2700128 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C2985739 (UMLS CUI [1,4])
C1549995 (UMLS CUI [1,5])
Code List
Record primary reason for abnormality in sedimentary microscopy
CL Item
Due to disease under study (D)
(Comment:en)
CL Item
Due to other concurrent disease (C)
(Comment:en)
CL Item
Reasonable possibility due to investigational product (T)
(Comment:en)
CL Item
Reasonable possibility due to other concomitant medication (M)
(Comment:en)
CL Item
Other, specify in the following item (X)
(Comment:en)
Primary reason for abnormality in sedimentary microscopy
Item
If answer 'X' was choosen as primary reason, specify abnormality in urinalysis sedimentary microscopy parameter choosen above.
text
C0042014 (UMLS CUI [1,1])
C2700128 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C2985739 (UMLS CUI [1,4])
C1549995 (UMLS CUI [1,5])