Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Has the subject taken any medication within 1 week PRIOR to the first dose of study medication?
Item
Has the subject taken any medication within 1 week PRIOR to the first dose of study medication?
boolean
C2826257 (UMLS CUI [1])
C0013230 (UMLS CUI [2,1])
C3174092 (UMLS CUI [2,2])
C0205435 (UMLS CUI [2,3])
Prior Medication - Drug Name
Item
Prior Medication - Drug Name
text
C2826257 (UMLS CUI [1])
C2360065 (UMLS CUI [2])
Prior Medication - Single Dose/ Unit
Item
Prior Medication - Single Dose/ Unit
text
C2826257 (UMLS CUI [1])
C1960417 (UMLS CUI [2])
Prior Medication - Frequency of this Dose
Item
Prior Medication - Frequency of this Dose
text
C2826257 (UMLS CUI [1])
C3476109 (UMLS CUI [2])
Item
Prior Medication - Route
text
C2826257 (UMLS CUI [1])
C0013153 (UMLS CUI [2])
Code List
Prior Medication - Route
CL Item
intra-articular (IA)
CL Item
intra-arterial (IAR)
CL Item
intra-dermal (ID)
CL Item
intra-muscular (IM)
CL Item
intra-thecal (IT)
CL Item
intra-venous (IV)
CL Item
subcutaneous (SC)
Prior Medication - Indication
Item
Prior Medication - Indication
text
C2826257 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Prior Medication - Duration of Therapy
Item
Prior Medication - Duration of Therapy
text
C2826257 (UMLS CUI [1,1])
C0444921 (UMLS CUI [1,2])
Prior Medication - End Date
Item
Prior Medication - End Date
date
C2826257 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Prior Medication - Continuing at end of study?
Item
Prior Medication - Continuing at end of study?
boolean
C2826257 (UMLS CUI [1,1])
C1553904 (UMLS CUI [1,2])
C2983670 (UMLS CUI [1,3])
Was a pregnancy test carried out?
Item
Was a pregnancy test carried out?
boolean
C0032976 (UMLS CUI [1])
If no pregnancy test was carried out, please specify reason
Item
If no pregnancy test was carried out, please specify reason
text
C0032976 (UMLS CUI [1,1])
C2826287 (UMLS CUI [1,2])
Date of pregnancy test
Item
Date of pregnancy test
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Pregnancy test result
integer
C0427777 (UMLS CUI [1])
Code List
Pregnancy test result
Was an alcohol breath test carried out?
Item
Was an alcohol breath test carried out?
boolean
C0202306 (UMLS CUI [1])
If no alcohol breath test was carried out, specify reason
Item
If no alcohol breath test was carried out, specify reason
text
C0202306 (UMLS CUI [1,1])
C2826287 (UMLS CUI [1,2])
If alcohol breath test was carried out, indicate date of alcohol breath test
Item
If alcohol breath test was carried out, indicate date of alcohol breath test
date
C0202306 (UMLS CUI [1,1])
C001100 (UMLS CUI [1,2])
Item
Alcohol breath test result
integer
C0202306 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Code List
Alcohol breath test result
Drug Screening (Urine) - Exact date end time of sampling
Item
Drug Screening (Urine) - Exact date end time of sampling
datetime
C0202274 (UMLS CUI [1])
C0870078 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
Were there any contra-indicated drugs detected?
Item
Were there any contra-indicated drugs detected?
boolean
C1511790 (UMLS CUI [1,1])
C4036061 (UMLS CUI [1,2])
C1301624 (UMLS CUI [1,3])
Drug Screening (Urine) - Type of drug
Item
Drug Screening (Urine) - Type of drug
text
C0202274 (UMLS CUI [1])
C0457591 (UMLS CUI [2])
Drug Screening (Urine) - Comment
Item
Drug Screening (Urine) - Comment
text
C0202274 (UMLS CUI [1])
C0947611 (UMLS CUI [2])
Vital Signs - Date and Time
Item
Vital Signs - Date and Time
datetime
C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Vital Signs - Semi-supine BP Systolic
Item
Vital Signs - Semi-supine BP Systolic
integer
C0518766 (UMLS CUI [1])
C0871470 (UMLS CUI [2,1])
C0522019 (UMLS CUI [2,2])
Vital Signs - Semi-supine BP Diastolic
Item
Vital Signs - Semi-supine BP Diastolic
integer
C0518766 (UMLS CUI [1])
C0428883 (UMLS CUI [2,1])
C0522019 (UMLS CUI [2,2])
Vital Signs - Semi-supine Hear Rate
Item
Vital Signs - Semi-supine Hear Rate
integer
C0518766 (UMLS CUI [1])
C0018810 (UMLS CUI [2,1])
C0522019 (UMLS CUI [2,2])
Vital Signs - Time
Item
Vital Signs - Time
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Vital Signs - Erect BP Systolic
Item
Vital Signs - Erect BP Systolic
integer
C0518766 (UMLS CUI [1])
C0871470 (UMLS CUI [2,1])
C0522014 (UMLS CUI [2,2])
Vital Signs - Erect BP Diastolic
Item
Vital Signs - Erect BP Diastolic
integer
C0518766 (UMLS CUI [1])
C0428883 (UMLS CUI [2,1])
C0522014 (UMLS CUI [2,2])
Vital Signs - Erect Heart Rate
Item
Vital Signs - Erect Heart Rate
integer
C0518766 (UMLS CUI [1])
C0018810 (UMLS CUI [2,1])
C0522014 (UMLS CUI [2,2])