Medical History findings
Item
Are there any Medical History findings excluding study indication that started before the subject signed the informed consent and that are considered relevant to the study?
boolean
C0262926 (UMLS CUI [1,1])
C2607943 (UMLS CUI [1,2])
Medical History finding
Item
Medical History finding
text
C0262926 (UMLS CUI [1,1])
C2607943 (UMLS CUI [1,2])
Start date
Item
Start date
date
C0808070 (UMLS CUI [1])
Ongoing
Item
Ongoing at subject's last visit
boolean
C0549178 (UMLS CUI [1])
date resolved
Item
If not ongoing, date resolved
date
C0011008 (UMLS CUI [1,1])
C2699488 (UMLS CUI [1,2])
Concomitant Medication
Item
Has the subject received any Concomitant Medication during the study period associated with Adverse Events or Primary Malignancy?
boolean
C2347852 (UMLS CUI [1])
Trade name
Item
Trade name
text
C2360065 (UMLS CUI [1])
Specify dose, unit and frequency
Item
Specify dose, unit and frequency
text
C1521902 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1521902 (UMLS CUI [2,1])
C0439148 (UMLS CUI [2,2])
C1521902 (UMLS CUI [3,1])
C0439603 (UMLS CUI [3,2])
Concomitant Medication Route of Administration
Item
Route
text
C2826730 (UMLS CUI [1])
Other Concomitant Medication Route of Administration
Item
Other, specify
text
C2826730 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Start date
Item
Start date
date
C0808070 (UMLS CUI [1])
Ongoing
Item
Ongoing at subjects last visit
boolean
C2826666 (UMLS CUI [1])
Stop date
Item
Stop date
date
C0806020 (UMLS CUI [1])
Indication
Item
Indication
text
C3146298 (UMLS CUI [1])
Dynamic search list
Item
Dynamic search list contains "Line No - Term - Start Date"
text
C0557959 (UMLS CUI [1,1])
C0745732 (UMLS CUI [1,2])
Other indication
Item
If indication is "Other'', specify
text
C3146298 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Concomitant Analgesic Medication
Item
Has the subject received any Concomitant Analgesic Medication during the study period?
boolean
C2347852 (UMLS CUI [1,1])
C0002771 (UMLS CUI [1,2])
Trade name
Item
Trade name
text
C2360065 (UMLS CUI [1])
Medication Dose
Item
Dose
text
C3174092 (UMLS CUI [1])
Unit
Item
Unit
text
C2348328 (UMLS CUI [1])
Medication frequency
Item
Frequency
text
C2826654 (UMLS CUI [1])
Concomitant Medication Route of Administration
Item
Route
text
C2826730 (UMLS CUI [1])
Other Concomitant Medication Route of Administration
Item
Other, specify
text
C2826730 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Start date
Item
Start date
date
C0808070 (UMLS CUI [1])
Concomitant Medication Ongoing
Item
Ongoing at subjects last visit
boolean
C2826666 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Indication
Item
Indication
text
C2826696 (UMLS CUI [1])
Dynamic search list
Item
Dynamic search list contains: "Line No - Term - Start Date"
text
C0557959 (UMLS CUI [1,1])
C0745732 (UMLS CUI [1,2])
Other Indication
Item
If indication is "Other", specify
text
C3146298 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
AE number
Item
AE number
integer
C0877248 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Cancer type
Item
Cancer type
text
C0872066 (UMLS CUI [1])
Other Cancer type
Item
Other, specify
text
C1707251 (UMLS CUI [1])
If not AML/MDS, histopathological results
Item
If not AML/MDS, histopathological results:
text
C0023467 (UMLS CUI [1,1])
C0243140 (UMLS CUI [1,2])
C3463824 (UMLS CUI [2,1])
C0243140 (UMLS CUI [2,2])
If AML/MDS, specify classification
Item
If AML/MDS, specify classification
text
C0023467 (UMLS CUI [1,1])
C0683326 (UMLS CUI [1,2])
C3463824 (UMLS CUI [2,1])
C0683326 (UMLS CUI [2,2])
If AML, specify percentage of blasts
Item
If AML, specify % of blasts
text
C0023467 (UMLS CUI [1,1])
C1318434 (UMLS CUI [1,2])
MDS Subtype
Item
If MDS, Subtype
text
C3463824 (UMLS CUI [1,1])
C0449560 (UMLS CUI [1,2])
Diagnostic findings
Item
Diagnostic findings
text
C0011900 (UMLS CUI [1])
Concomitant radiotherapy
Item
Has the subject received any concomitant radiotherapy during study?
boolean
C1522449 (UMLS CUI [1,1])
C1707479 (UMLS CUI [1,2])
Regimen number
Item
Regimen number
text
C0040808 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Irradiation site
Item
Irradiated location 1
text
C2169202 (UMLS CUI [1])
Irradiation site
Item
Irradiated location 2
text
C2169202 (UMLS CUI [1])
Irradiation site
Item
Irradiated location 3
text
C2169202 (UMLS CUI [1])
Intention
Item
Intent
text
C1283828 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
Was this radiotherapy given to relieve skeletal symptoms
Item
Was this radiotherapy given to relieve skeletal symptoms?
boolean
C1522449 (UMLS CUI [1,1])
C0683368 (UMLS CUI [1,2])
C1301676 (UMLS CUI [1,3])
Type of radiotherapy
Item
Type of radiotherapy
text
C1522449 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Date of first fraction
Item
Date of first fraction
date
C1522449 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Date of last fraction
Item
Date of last fraction
date
C1522449 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Total cumulative dose
Item
Total cumulative dose
text
C2986497 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
concurrent diagnostic or therapeutic procedures
Item
Has the subject undergone any concurrent diagnostic or therapeutic procedures associated with the cancer under study (including surgery and biopsy)?
boolean
C0205420 (UMLS CUI [1,1])
C1576868 (UMLS CUI [1,2])
Procedure
Item
Procedure
text
C0184661 (UMLS CUI [1])
Other procedure
Item
Other procedure: please specify
text
C0393107 (UMLS CUI [1])
Location
Item
Location
text
C0450429 (UMLS CUI [1])
Other location
Item
Other location: please specify
text
C0450429 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Date of procedure
Item
Date of procedure
date
C2584899 (UMLS CUI [1])
Purpose of procedure
Item
Purpose of procedure
text
C0517852 (UMLS CUI [1])
Histopathological or surgery findings
Item
Histopathological or surgery findings
text
C0311392 (UMLS CUI [1,1])
C0243140 (UMLS CUI [1,2])
C0311392 (UMLS CUI [2,1])
C0038895 (UMLS CUI [2,2])