Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Course Number
Item
Course Number
integer
C0237753 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Investigator
Item
Investigator
text
C2826892 (UMLS CUI [1])
Date for which these reference ranges became effective
Item
Date for which these reference ranges became effective
date
C0883335 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Laboratory Name
Item
Laboratory Name
text
C3258037 (UMLS CUI [1])
Laboratory Address
Item
Laboratory Address
text
C1442065 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
Item
Reference range gender
text
C0883335 (UMLS CUI [1,1])
C0079399 (UMLS CUI [1,2])
Code List
Reference range gender
Age range
Item
Age range
text
C0001779 (UMLS CUI [1,1])
C1514721 (UMLS CUI [1,2])
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1])
Total Daily Dose
Item
Total Daily Dose
text
C2348070 (UMLS CUI [1])
Item
Route
text
C0013153 (UMLS CUI [1])
CL Item
intramuscular (IM)
CL Item
intra-arterial (IAR)
CL Item
intra-articular injection (IA)
CL Item
subcutaneous (SC)
Medical Condition
Item
Medical Condition
text
C0012634 (UMLS CUI [1])
Medication Start Date
Item
Medication Start Date
date
C2826734 (UMLS CUI [1])
Medication End Date
Item
Medication End Date
date
C2826744 (UMLS CUI [1])
Item
Medication Continuing
integer
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Code List
Medication Continuing
CL Item
Medication Continuing (1)
Item
If no adverse experiences occured during the study, please sign form below and mark this box
integer
C0877248 (UMLS CUI [1,1])
C1298908 (UMLS CUI [1,2])
Code List
If no adverse experiences occured during the study, please sign form below and mark this box
CL Item
No Adverse Experience (1)
Adverse Experience
Item
Adverse Experience
text
C0877248 (UMLS CUI [1])
Adverse Experience Onset Date and Time
Item
Adverse Experience Onset Date and Time
datetime
C2985916 (UMLS CUI [1])
C2697889 (UMLS CUI [2])
Adverse Experience End Date and Time
Item
Adverse Experience End Date and Time
datetime
C2826793 (UMLS CUI [1])
Item
Adverse Experience Outcome
integer
C1705586 (UMLS CUI [1])
Code List
Adverse Experience Outcome
Item
Experience Course
integer
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Code List
Experience Course
If Intermittent Course, record number of episodes
Item
If Intermittent Course, record number of episodes
integer
C0750729 (UMLS CUI [1,1])
C0205267 (UMLS CUI [1,2])
C4086638 (UMLS CUI [1,3])
Common Toxicity Grade
Item
Common Toxicity Grade
integer
C2826262 (UMLS CUI [1])
Item
Action Taken with Respect to Investigational Drug
integer
C2826626 (UMLS CUI [1])
Code List
Action Taken with Respect to Investigational Drug
CL Item
Dose increased (3)
CL Item
Drug interrupted/ restarted (5)
CL Item
Dose delayed and decreased (7)
Item
Relationship to Investigational Drug
integer
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Code List
Relationship to Investigational Drug
CL Item
Suspected (reasonable possibility) (2)
Corrective Therapy
Item
Corrective Therapy
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Was patient withdrawn due to this specific AE?
Item
Was patient withdrawn due to this specific AE?
boolean
C0422727 (UMLS CUI [1,1])
C1518404 (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
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])