Center Number
Item
Center Number
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
text
C1709561 (UMLS CUI [1])
Patient ID
Item
Patient ID
text
C2348585 (UMLS CUI [1])
Are there any non-serious adverse events to report?
Item
Are there any non-serious adverse events to report?
boolean
C1518404 (UMLS CUI [1])
Non-Serious adverse Event
Item
Non-Serious adverse Event
text
C1518404 (UMLS CUI [1])
Non-Serious adverse Event Onset Date
Item
Non-Serious adverse Event Onset Date
date
C2985916 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Non-Serious adverse Event End Date
Item
Non-Serious adverse Event End Date
date
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Non-serious adverse Event Outcome
integer
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Code List
Non-serious adverse Event Outcome
CL Item
Ongoing (at end of study) (2)
CL Item
Deíed --> see SAE section (3)
Item
Non-Serious adverse Event Experience Course
integer
C1518404 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Code List
Non-Serious adverse Event Experience Course
Non-Serious adverse Event Common Toxicity Grade
Item
Non-Serious adverse Event Common Toxicity Grade
integer
C1518404 (UMLS CUI [1,1])
C2826262 (UMLS CUI [1,2])
Item
Non-Serious adverse Event - Action Taken with Respect to investigational Drug
integer
C1518404 (UMLS CUI [1,1])
C2826626 (UMLS CUI [1,2])
Code List
Non-Serious adverse Event - Action Taken with Respect to investigational Drug
CL Item
Drug interrupted/restarted (3)
CL Item
Dose delayed and reduced (6)
Item
Non-Serious adverse Event - Relationship to Investigational Drug
integer
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Code List
Non-Serious adverse Event - Relationship to Investigational Drug
CL Item
Probably Unrelated (2)
CL Item
Possibly Related (3)
Non-Serious adverse Event - Corrective Therapy
Item
Non-Serious adverse Event - Corrective Therapy
boolean
C1518404 (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Was patient withdrawn due to this specific AE?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Was patient withdrawn due to this specific AE?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])
Serious Adverse Event
Item
Serious Adverse Event
text
C1519255 (UMLS CUI [1])
Person Reporting SAE:
Item
Person Reporting SAE:
text
C0008961 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Serious Adverse Event Onset Date
Item
Serious Adverse Event Onset Date
date
C2985916 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Serious Adverse Event Onset Time
Item
Serious Adverse Event Onset Time
time
C1519255 (UMLS CUI [1,1])
C0449244 (UMLS CUI [1,2])
Serious Adverse Event End Date
Item
Serious Adverse Event End Date
date
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Serious Adverse Event End Time
Item
Serious Adverse Event End Time
time
C1519255 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Specify reason(s) for considering this an SAE.
integer
C1519255 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Code List
Specify reason(s) for considering this an SAE.
CL Item
Results in death (1)
CL Item
Life threatening (2)
CL Item
Results in hospitalization or prolongation of existing hospitalization (3)
CL Item
Results in disability / incapacity (4)
CL Item
Congenital abnormality / birth defect (5)
CL Item
Other (see definition), specify: (6)
If other reason(s) for considering this an SAE, specify
Item
If other reason(s) for considering this an SAE, specify
text
C1519255 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item
Serious Adverse Event Outcome
integer
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Code List
Serious Adverse Event Outcome
CL Item
Died (Complete Patient Form D) (3)
Item
Serious Adverse Event - Experience Course
integer
C1519255 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Code List
Serious Adverse Event - Experience Course
Serious Adverse Event - Common Toxicity Grade
Item
Serious Adverse Event - Common Toxicity Grade
integer
C1519255 (UMLS CUI [1,1])
C2826262 (UMLS CUI [1,2])
Item
Serious Adverse Event - Action Taken with Respect to Investigational Drug
integer
C1519255 (UMLS CUI [1,1])
C2826626 (UMLS CUI [1,2])
Code List
Serious Adverse Event - Action Taken with Respect to Investigational Drug
CL Item
Drug interrupted/restarted (3)
CL Item
Dose delayed and reduced (6)
Did the SAE abate?
Item
Did the SAE abate?
boolean
C1519255 (UMLS CUI [1,1])
C3853704 (UMLS CUI [1,2])
If study medication was interrupted, stopped, or dose reduced, was study Medication reintroduced (or dose decresed)?
Item
If study medication was interrupted, stopped, or dose reduced, was study Medication reintroduced (or dose decresed)?
boolean
C0304229 (UMLS CUI [1,1])
C1707811 (UMLS CUI [1,2])
If study Medication was reintroduced, did SAE recur?
Item
If study Medication was reintroduced, did SAE recur?
boolean
C0304229 (UMLS CUI [1,1])
C1707811 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0034897 (UMLS CUI [2,2])
Item
Serious Adverse Event - Relationship to Investigatinoal Drug
integer
C1519255 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Code List
Serious Adverse Event - Relationship to Investigatinoal Drug
CL Item
Propably Unrelated (2)
CL Item
Possibly Related (3)
Item
If Relationship to Investigational Product is "Unrelated" or "Probably Unrelated", the SAE is propably associated with...
integer
C1519255 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0445356 (UMLS CUI [2])
C0332281 (UMLS CUI [3])
Code List
If Relationship to Investigational Product is "Unrelated" or "Probably Unrelated", the SAE is propably associated with...
CL Item
Protocol design of procedures (but not to study drug), specify (1)
CL Item
Another condition (e.g., condition under study, intercurrent illness), specify (2)
CL Item
Another Drug, specify (3)
If SAE is associated with Protocol design or procedures, specify
Item
If SAE is associated with Protocol design or procedures, specify
text
C1519255 (UMLS CUI [1,1])
C0184661 (UMLS CUI [1,2])
C0332281 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
If SAE ist associated with another condition, specify
Item
If SAE ist associated with another condition, specify
text
C1519255 (UMLS CUI [1,1])
C0348080 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0332281 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
If SAE is associated with another Drug, specify
Item
If SAE is associated with another Drug, specify
text
C1519255 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0332281 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
Serious Adverse Event - Corrective Therapy
Item
Serious Adverse Event - Corrective Therapy
boolean
C1519255 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Was patient withdrawn due to this specific SAE?
Item
Was patient withdrawn due to this specific SAE?
boolean
C0422727 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Serious Adverse Event - Remarks
Item
Serious Adverse Event - Remarks
text
C1519255 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Laboratory Test
Item
Laboratory Test
text
C0022885 (UMLS CUI [1])
Laboratory Test Date
Item
Laboratory Test Date
date
C2826641 (UMLS CUI [1])
Laboratory Test Value
Item
Laboratory Test Value
text
C0587081 (UMLS CUI [1])
Laboratory Test Units
Item
Laboratory Test Units
text
C1519795 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Laboratory Test Normal Range
Item
Laboratory Test Normal Range
text
C1096215 (UMLS CUI [1])
Serious Adverse Event - Investigator's Signature
Item
Serious Adverse Event - Investigator's Signature
text
C1519255 (UMLS CUI [1,1])
C2346576 (UMLS CUI [1,2])
Investigator's Name
Item
Investigator's Name
text
C2826892 (UMLS CUI [1])
Investigator's Siganture Date Signed
Item
Investigator's Siganture Date Signed
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Medical Monitor‘s Signature
Item
Medical Monitor‘s Signature
text
C1708968 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
Medical Monitor's Name
Item
Medical Monitor's Name
text
C0027365 (UMLS CUI [1,1])
C1708968 (UMLS CUI [1,2])
Medical Monitors Signature Date Signed
Item
Medical Monitors Signature Date Signed
date
C1708968 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Were any Medications taken by the patient up to 14 days prior to first administration of study medication and/or during the study?
Item
Were any Medications taken by the patient up to 14 days prior to first administration of study medication and/or during the study?
boolean
C2826257 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Line Number
Item
Line Number
integer
C0449788 (UMLS CUI [1])
Medication Generic Name
Item
Medication Generic Name
text
C0013227 (UMLS CUI [1,1])
C0592502 (UMLS CUI [1,2])
Medication Dose
Item
Medication Dose
text
C3174092 (UMLS CUI [1])
Medication Units
Item
Medication Units
text
C0013227 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Medication Route
Item
Medication Route
text
C0013153 (UMLS CUI [1])
Medication Frequency
Item
Medication Frequency
text
C3476109 (UMLS CUI [1])
Medication Indication
Item
Medication Indication
text
C2826696 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
Item
Medication prior to study medication
integer
C2826257 (UMLS CUI [1])
C0304229 (UMLS CUI [2])
Code List
Medication prior to study medication
Item
Concomitant Medication
integer
C2347852 (UMLS CUI [1])
Code List
Concomitant Medication
Medication Start Date
Item
Medication Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Medication End Date
Item
Medication End Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
OR Ongoing at end of study
integer
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Code List
OR Ongoing at end of study