Information:
Error:
Instructions: Complete and submit thie form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice. Print text in capital letters. Avoid contact with the edges of the boxes. Cirlce amended items and check "Amended data" box to teh right. If submitting by mail, retain a copy for your records and send the original form for mazimum clarity in transmission and fax to 919-416-4990. If submistting electronically, click the Send button when you have completed the PDF version of the form.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
CALGBProtocolNumber
Item
CALGB Study No.
text
CALGBPatientID
Item
CALGB Patient ID
text
AmendedDataInd
Item
Are data amended?
text
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
Patient Initials
Item
Patient's Initials (Last, First, Middle)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
ParticipatingGroup
Item
Participating Group
text
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PatientHospitalNumber
Item
Patient Hospital No.
text
ParticipatingGroupProtocolNo.
Item
Participating Group Protocol No.
text
MainMemberInstitution/Affiliate
Item
Institution/Affiliate
text
ParticipatingGroupPatientID
Item
Participating Group Patient ID:
text
IntervalReportFromDate
Item
Reporting period Start Date
date
IntervalReportFromDate
Item
Reporting period Start Date
date
IntervalReportToDate
Item
Reporting period End Date (MM DD YYYY)
date
IntervalReportToDate
Item
Reporting period End Date (MM DD YYYY)
date
CL Item
Current Phase Of Leukemia Treatment For Patient Is Induction (Induction)
CL Item
Current Phase Of Leukemia Treatment For Patient Is Consolidation (Consolidation)
CL Item
Current Phase Of Leukemia Treatment For Patient Is Follow-up, Or Patient Is Off Therapy (Follow-Up/Off Therapy)
CL Item
Current Phase Of Leukemia Treatment For Patient Is Specified Other Phase (Other, specify)
TreatmentPhase,Other
Item
Other, specify (treatment phase)
text
ProtocolTreatmentInd
Item
Did the patient receive any protocol treatment?
boolean
TreatmentFirstDoseBeginDate
Item
Date of first dose for this reporting period (MM DD YYYY)
date
TotalCourseNumber
Item
Number of courses or cycles given this reporting period
float
TreatmentLastDoseEndDate
Item
Date of last dose for this reporting period (MM DD YYYY)
date
AgentTotalDose
Item
G3139 (dose) (mg)
float
AgentTotalDose
Item
G3139 (dose) (mg)
float
AgentTotalDose
Item
G3139 (dose) (mg)
float
Item
If the treatment ended this period, reason treatment ended or not given (Mark one with an X)
text
Code List
If the treatment ended this period, reason treatment ended or not given (Mark one with an X)
CL Item
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
CL Item
Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)
CL Item
Progression Of Disease Occurred Prior To The Patient Beginning Protocol Therapy (Disease progression, relapse prior to beginning protocol therapy)
CL Item
Toxicity/side Effects/complications (Toxicity/side effects/complications)
CL Item
Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdraw or refusal after beginning protocol therapy)
CL Item
Patient Withdrawal Or Refusal Prior To Beginning Protocol Therapy (Patient withdraw or refusal before beginning protocol therapy)
CL Item
Death Of Patient Occurred After The Patient Began Protocol Therapy (Death after beginning protocol therapy)
CL Item
Death Prior To Beginning Protocol Therapy (Death prior to beginning protocol therapy)
CL Item
Alternative Therapy (Alternative therapy)
CL Item
Other (Other complicating disease)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
C0205394 (UMLS 2011AA)
CL Item
Other, Specify (Other, specify)
OffTreatmentReason,Other
Item
Other, specify (reason treatment ended)
text
Item
Were there any dose modifications or additions/omissions to protocol treatment (Mark one with an X)
text
Code List
Were there any dose modifications or additions/omissions to protocol treatment (Mark one with an X)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C1298908 (UMLS 2011AA)
CL Item
(i.e., The Treatment Was Changed According To Protocol Guidelines) (Yes, planned)
CL Item
(i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (Yes, unplanned)
DoseModificationReason
Item
If yes, unplanned, specify change
text
CompletedBy
Item
Completed by (First Name, Last Name)
text