PatientInternationalBreastCancerStudyGroupIdentifierNumber
Item
IBCSG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25530 (NCI Thesaurus Property)
C1512890 (UMLS 2011AA Property)
PatientInitialsName
Item
Patient Initials
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
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus ValueDomain)
C25155 (NCI Thesaurus Property)
C0005615 (UMLS 2011AA Property)
ParticipatingCenter/Affiliate
Item
Participating Center/Affiliate
text
CenterCode
Item
Center Code
text
Item
Did the patient complete chemotherapy?
text
Code List
Did the patient complete chemotherapy?
CL Item
No, Will Never Start (no, will never start)
CL Item
No, Started But Stopped Early (no, started but stopped early)
CL Item
Yes, Completed With Modifications Or Delays Of One Week Or More (yes, completed with modifications or delays of one week or more)
CL Item
Yes, Completed As Planned (yes, completed as planned)
Item
Reason code, specify (reason treatment ended)
text
Code List
Reason code, specify (reason treatment ended)
CL Item
Patient Refused (patient refused)
CL Item
Adverse Event (adverse event)
C41331 (NCI Thesaurus)
C0877248 (UMLS 2011AA)
CL Item
Medical Decision (medical decision)
CL Item
Recurrence (recurrence)
C3352 (NCI Thesaurus)
C0034897 (UMLS 2011AA)
CL Item
Death On Study (death on study)
CL Item
Error (error)
C0743559 (NCI Metathesaurus)
CL Item
Other, Specify (other, specify)
Adverseevent,specify
Item
adverse event, specify
text
Medicaldecision,specify
Item
medical decision, specify
text
OffTreatmentReason,Other
Item
other, specify
text
Item
Reasons chemotherapy was delayed or modified
text
Code List
Reasons chemotherapy was delayed or modified
CL Item
Hematologic Toxicity (hematologic toxicity)
CL Item
Other Toxicity, Specify (other toxicity, specify)
CL Item
Reason Other Than Toxicity, Specify (reason other than toxicity, specify)
othertoxicity,specify
Item
other toxicity, specify
text
reasonotherthantoxicity,specify
Item
reason other than toxicity, specify
text
PriorChemotherapyBeginDate
Item
Date of first dose of chemotherapy
date
Dateoflastdoseofchemotherapy
Item
Date of last dose of chemotherapy
text
TotalCourseNumber
Item
Total number of cycles of the regimen of chemotherapy given
double
InvestigatorSignature
Item
Investigator Signature
text
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
AgentName
Item
Agent Name
text
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C0450442 (UMLS 2011AA ValueDomain)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
AgentDoseLevelValue
Item
Agent Dose
text
C25488 (NCI Thesaurus Property)
C0178602 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25554 (NCI Thesaurus Property)
C0441889 (UMLS 2011AA Property)
AgentAdminRoute
Item
Route of Administration
text
Schedule&Frequency
Item
Schedule & Frequency
text
Item
Leukocytes CTCAE Grade
double
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Code List
Leukocytes CTCAE Grade
CL Item
>= 1.0 - <2.0 X 10e9/l; >= 1000 - <2000/mm(3) (Grade 3)
CL Item
<1.0 X 10e9/l; <1000/mm(3) (Grade 4)
CL Item
Death Related To Toxicity (Grade 5)
Item
Platelets CTCAE Grade
double
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Code List
Platelets CTCAE Grade
CL Item
>=10.0 - <50.0 X 10e9/l; >=10,000 - <50,000/mm(3) (Grade 3)
CL Item
<10.0 X 10e9/l; <10,000/mm(3) (Grade 4)
CL Item
Death Related To Toxicity (Grade 5)
Item
Hemoglobin CTCAE Grade
double
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Code List
Hemoglobin CTCAE Grade
CL Item
6.5 - <8.0 G/dl; 65 - <80 G/l; 4.0 - <4.9 Mmol/l (Grade 3)
CL Item
Grade 4 (Grade 4)
CL Item
Death Related To Toxicity (Grade 5)
Item
Mucositis/Stomatis CTCAE Grade
double
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Code List
Mucositis/Stomatis CTCAE Grade
CL Item
Painful Erythema, Edema, Or Ulcers Requiring Iv Hydration (Grade 3)
CL Item
Severe Ulceration Or Requires Parenteral Or Enteral Nutritional Support Or Prophylactic Intubation (Grade 4)
CL Item
Death Related To Toxicity (Grade 5)
Item
Fatigue CTCAE Grade
double
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Code List
Fatigue CTCAE Grade
CL Item
Severe (e.g., Decrease In Performance Status By >= 2 Ecog Levels Or 40% Karnofsky Or Lansky) Or Loss Of Ability To Perform Some Activities (Grade 3)
CL Item
Bedridden Or Disabling (Grade 4)
Item
Dizziness/lightheadedness CTCAE Grade
double
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Code List
Dizziness/lightheadedness CTCAE Grade
CL Item
Interfering With Activities Of Daily Living (Grade 3)
CL Item
Bedridden Or Disabling (Grade 4)
CL Item
Death Related To Toxicity (Grade 5)
Item
Somnolence/Depressed level of consciousness CTCAE Grade
double
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Code List
Somnolence/Depressed level of consciousness CTCAE Grade
CL Item
Obtundation Or Stupor; Difficult To Arouse; Interfering With Activities Of Daily Living (Grade 3)
CL Item
Coma (Grade 4)
C34497 (NCI Thesaurus)
C0009421 (UMLS 2011AA)
CL Item
Death Related To Toxicity (Grade 5)
Item
Memory impairment CTCAE Grade
double
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Code List
Memory impairment CTCAE Grade
CL Item
Memory Loss Interfering With Activities Of Daily Living (Grade 3)
CL Item
Amnesia (Grade 4)
C2867 (NCI Thesaurus)
C0002622 (UMLS 2011AA)
Item
Mood alternation-depression CTCAE Grade
double
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Code List
Mood alternation-depression CTCAE Grade
CL Item
Severe Mood Alteration Interfering With Activities Of Daily Living (Grade 3)
CL Item
Suicidal Ideation Or Danger To Self (Grade 4)
CL Item
Death Related To Toxicity (Grade 5)
Item
Neuropathy-sensory CTCAE Grade
double
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C0151313 (NCI Metathesaurus Property)
Code List
Neuropathy-sensory CTCAE Grade
CL Item
Sensory Loss Or Paresthesia Interfering With Activities Of Daily Living (Grade 3)
CL Item
Permanent Sensory Loss That Interferes With Function (Grade 4)
CL Item
Death Related To Toxicity (Grade 5)
Item
Did the patient have other Grade 3 or higher adverse event(s)?
text
Code List
Did the patient have other Grade 3 or higher adverse event(s)?
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CTCAdverseEventTermSpecify
Item
If yes, specify other CTCAE terms not listed
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25703 (NCI Thesaurus Property)
C1515273 (UMLS 2011AA Property)
Item
CTCAE Grade
double
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL Item
Severe And Undesirable Adverse Event (Grade 3)
CL Item
Life-threatening Or Disabling Adverse Event (Grade 4)
CL Item
Death Related To Adverse Event (Grade 5)
C48275 (NCI Thesaurus)
C1705232 (UMLS 2011AA)