LateAdverseEventOnsetDate
Item
Date of onset: (day month year)
date
CTCAdverseEvent,Follow-upReportDate
Item
Date of this follow-up report: (day month year)
date
Item
Action taken regarding protocol treatment: (select all that apply)
text
Code List
Action taken regarding protocol treatment: (select all that apply)
CL Item
None (None)
C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)
CL Item
Dose Reduced (Dose reduced)
C49505 (NCI Thesaurus)
C1707814 (UMLS 2011AA)
CL Item
Treatment Delayed (Treatment delayed)
CL Item
Treatment Temporarily Discontinued (Treatment temporarily discontinued)
CL Item
Treatment Permanently Discontinued (Treatment permanently discontinued)
CL Item
Other, Specify (Other, specify)
Other,
Item
Other, (specify)
text
Treatments/proceduresforSAE:
Item
Treatments/procedures for SAE: (please describe)
text
Item
Were there changes in previous Concomitant Therapy? (Complete ONLY if different from initial report in Section A.)
text
Code List
Were there changes in previous Concomitant Therapy? (Complete ONLY if different from initial report in Section A.)
AgentName
Item
Name of Medication
text
AgentAdminRoute
Item
Admin. (e.g., i.v., p.o.)
text
AgentTotalDose(perday)
Item
Daily Dosage
double
AgentBeginDate
Item
Date Started (day month year)
date
AgentEndDate
Item
Date Stopped (day month year)
date
Item
Outcome (select one)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C26726 (NCI Thesaurus Property)
C0009450 (UMLS 2011AA Property)
Code List
Outcome (select one)
CL Item
Resolved: (Resolved:)
CL Item
Resolved with Sequelae: (Resolved with Sequelae:)
CL Item
Not resolved/ongoing (Not resolved/ongoing)
CL Item
Death, date of death: (Death, date of death:)
ResolvedwithSequelae
Item
Resolved with Sequelae: (please specify)
text
DeathReason
Item
Cause of death:
text
Item
Autopsy Report available?
text
Code List
Autopsy Report available?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes.)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
InvestigatorSignature
Item
Investigator/Designee Signature
text
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
InvestigatorSignature
Item
Investigator/Designee Signature
text
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
PhoneNumber
Item
Phone number:
double
TreatingPhysician
Item
MD Name (please print:)
text
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25741 (NCI Thesaurus ObjectClass)
C0031831 (UMLS 2011AA ObjectClass)
C25705 (NCI Thesaurus ObjectClass)
C1522326 (UMLS 2011AA ObjectClass)
FaxNumber
Item
Fax number:
double
InvestigatorSignatureDate
Item
Date (day month year)
date
PatientStudyID,CoordinatingGroup
Item
Patient ID Number (Study No.)
text
PatientInitialsName
Item
Patient Initials (f m fl sl)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
PatientBirthDate
Item
Patient's Date of Birth (day)
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
MainMemberInstitution/Affiliate
Item
Participating Center/Affiliate
text
ParticipatingGroupCode
Item
Center Code (Ver.#1)
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)