Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Date of visit/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1])
Item
Visit Type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
CL Item
End of treatment/Early withdrawal (1)
Item
Were haematology lab samples taken?
text
C0022885 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
Code List
Were haematology lab samples taken?
Item
Were chemistry lab samples taken?
text
C0008000 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Code List
Were chemistry lab samples taken?
Item
Was a blood smear performed?
text
C2238079 (UMLS CUI [1])
Code List
Was a blood smear performed?
Item
Were coagulation parameters calculated?
text
C1441506 (UMLS CUI [1,1])
C0005789 (UMLS CUI [1,2])
Code List
Were coagulation parameters calculated?
Item
Were renal assessments performed?
text
C0232804 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Code List
Were renal assessments performed?
Item
Was a PK sample taken?
text
C1277698 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
Code List
Was a PK sample taken?
Item
Were vitals signs taken?
text
C0518766 (UMLS CUI [1])
Code List
Were vitals signs taken?
Item
Were ophthalmic exams done?
text
C0200149 (UMLS CUI [1])
Code List
Were ophthalmic exams done?
Item
Ophthalmic exams type
text
C0332307 (UMLS CUI [1,1])
C0200149 (UMLS CUI [1,2])
Code List
Ophthalmic exams type
Item
Was WHO bleeding scale assessed?
text
C0043237 (UMLS CUI [1,1])
C3251812 (UMLS CUI [1,2])
C0681889 (UMLS CUI [1,3])
Code List
Was WHO bleeding scale assessed?
Item
Was a quality of life assessment performed?
text
C0034380 (UMLS CUI [1])
Code List
Was a quality of life assessment performed?
Item
Is subject less than 6 years of age?
text
C0001779 (UMLS CUI [1])
Code List
Is subject less than 6 years of age?
Item
Was the investigational product stopped permanently before the scheduled end of the treatment period?
text
C0304229 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0444930 (UMLS CUI [1,4])
C2347804 (UMLS CUI [1,5])
Code List
Was the investigational product stopped permanently before the scheduled end of the treatment period?
Item
Select primary reason the investigational product was stopped
integer
C0205225 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0444930 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
Code List
Select primary reason the investigational product was stopped
CL Item
Adverse Event (1)
CL Item
Lack of efficacy (2)
CL Item
Subject reached protocol defined stopping criteria (3)
CL Item
Study closed/terminated (4)
CL Item
Lost to Follow-Up (5)
CL Item
Investigator discretion (6)
CL Item
Decision by subject or proxy (7)
Item
Adverse event, subreason
integer
C0877248 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Code List
Adverse event, subreason
Investigator discretion, specification
Item
If Investigator discretion is the primary reason the investigational product was stopped, please specify
text
C2348235 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
C0022423 (UMLS CUI [1,3])
Decision by subject or proxy, specification
Item
If Decision by subject or proxy is the primary reason the investigational product was stopped, please specify
text
C2348235 (UMLS CUI [1,1])
C0422727 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,3])
C2348235 (UMLS CUI [2,1])
C0422727 (UMLS CUI [2,2])
C0600420 (UMLS CUI [2,3])
C0679006 (UMLS CUI [2,4])