Is the subject suffering from or has he/she ever suffered from any significant medical or surgical conditions since screening?
Item
Is the subject suffering from or has he/she ever suffered from any significant medical or surgical conditions since screening?
boolean
C0012634 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
Is the subject suffering from or has he/she ever suffered from any significant medical or surgical conditions since treatment period 1?
Item
Is the subject suffering from or has he/she ever suffered from any significant medical or surgical conditions since treatment period 1?
boolean
C0012634 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Year of first diagnosis
Item
Year of first diagnosis
partialDate
C0439234 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Diagnosis status
integer
C0011900 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Code List
Diagnosis status
Physical Examination - Date
Item
Physical Examination - Date
date
C2826643 (UMLS CUI [1])
Physical Examination - Time
Item
Physical Examination - Time
time
C2826761 (UMLS CUI [1])
Has there been any change from the last examination (screening)?
Item
Has there been any change from the last examination (screening)?
boolean
C0031809 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
Physical Examination - Change
Item
Physical Examination - Change
text
C0031809 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
Physical Examination - Date
Item
Physical Examination - Date
date
C2826643 (UMLS CUI [1])
Physical Examination - Time
Item
Physical Examination - Time
time
C2826761 (UMLS CUI [1])
Has there been any change from the last examination (period 1)?
Item
Has there been any change from the last examination (period 1)?
boolean
C0031809 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
Physical Examination - Change
Item
Physical Examination - Change
text
C0031809 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
Physical Examination - Date
Item
Physical Examination - Date
date
C2826643 (UMLS CUI [1])
Physical Examination - Time
Item
Physical Examination - Time
time
C2826761 (UMLS CUI [1])
Has there been any change from the last examination (Period 1 Day -1)?
Item
Has there been any change from the last examination (Period 1 Day -1)?
boolean
C0031809 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
Physical Examination - Change
Item
Physical Examination - Change
text
C0031809 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
Investigator's Signature
Item
Investigator's Signature
text
C2346576 (UMLS CUI [1])
Investigator's Signature Date
Item
Investigator's Signature Date
date
C1519316 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Was a pregnancy test carried out?
Item
Was a pregnancy test carried out?
boolean
C0032976 (UMLS CUI [1])
If no pregnancy test has been carried out, please specify reason
Item
If no pregnancy test has been carried out, please specify reason
text
C0032976 (UMLS CUI [1,1])
C2826287 (UMLS CUI [1,2])
Date and time of pregnancy test
Item
Date and time of pregnancy test
datetime
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
Result of pregnancy test
integer
C0427777 (UMLS CUI [1])
Code List
Result of pregnancy test
Item
Please mark box for test type
integer
C0032976 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Code List
Please mark box for test type
CL Item
Dipstick urine HCG (1)
CL Item
Other, please specify (3)
If other test type, specify
Item
If other test type, specify
text
C0032976 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Laboratory name, if applicable
Item
Laboratory name, if applicable
text
C1882331 (UMLS CUI [1])