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  1. StudyEvent: E1900 Induction Treatment Form
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Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
ECOG clinical trial administrative data
ECOGProtocolNo.
Item
ECOG Protocol No.
text
ECOGPatientID
Item
ECOG Patient ID
text
RegistrationStep
Item
Registration Step
text
Patient'sName
Item
Patient?s Name
text
ParticipatingGroupProtocolNo.
Item
Participating Group Protocol No.
text
ParticipatingGroupPatientID
Item
Participating Group Patient ID
text
MainMemberInstitution/Affiliate
Item
Institution/Affiliate
text
AmendedDataInd
Item
Are data amended? (If yes, please circle amended items in red)
boolean
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
Item Group
Vital Status
Item
Patient?s Vital Status
text
CL.2
Code List
Patient?s Vital Status
CL Item
Alive (Alive)
CL Item
Dead (Dead)
DeathDate/LastContactDate
Item
Date of Last Contact or Death (M D Y)
date
Item
Cause of Death (if applicable)
text
CL.3
Code List
Cause of Death (if applicable)
CL Item
Due To Protocol Treatment (Due to protocol treatment)
CL Item
Due To This Disease (Due to this disease)
CL Item
Due To Other Cause (Due to other cause)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
DeathReason,Specify
Item
Describe cause of death
text
Item Group
Treatment Cycle Information
Item
Assigned Treatment Arm (Choose one)
text
CL.4
Code List
Assigned Treatment Arm (Choose one)
CL Item
Arm A - Daunorubicin 45 mg/m2 (Arm A - Daunorubicin 45 mg/m2)
CL Item
Arm B - Daunorubicin 90 mg/m2 (Arm B - Daunorubicin 90 mg/m2)
Item
Cycle
text
CL.5
Code List
Cycle
CL Item
Cycle 1 (Cycle 1)
CL Item
Cycle 2 (Cycle 2)
PatientWeight
Item
Weight for this cycle (kg)
float
TreatmentBeginDate
Item
Treatment Begin Date
date
AgentInitialDose
Item
Cytarabine Initial Dose
float
AgentDuration
Item
Number of days GM-CSF was given
float
AgentTotalCumulativeDose
Item
GM-CSF Total Cumulative Dose
float
Wasintrathecalmethotrexateorcytarabineadministered?
Item
Was intrathecal methotrexate or cytarabine administered? (choose one)
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
Item
Were there any dose modifications or additions/omissions to protocol treatment? (Choose one:)
text
CL.7
Code List
Were there any dose modifications or additions/omissions to protocol treatment? (Choose one:)
CL Item
No (No)
C49487 (NCI Thesaurus)
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)
Non-ProtocolTherapyInd,DuringTreatment
Item
Was any non-protocol therapy given during protocol treatment? (not previously reported)
boolean
TreatmentEndDate
Item
Last date (any modality of) protocol therapy was given
date
Item
Reason Treatment Ended (Choose one)
text
CL.9
Code List
Reason Treatment Ended (Choose one)
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
Toxicity/side Effects/complications (Toxicity/side effects/complications)
CL Item
Death After Beginning Protocol Therapy (Death after beginning protocol therapy)
CL Item
Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal or refusal after beginning protocol therapy)
CL Item
Alternative Therapy (Alternative therapy)
CL Item
Patient Off-treatment For Other Complicating Disease (Other complicating disease)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
OffTreatmentReason,ComplicatingDisease
Item
Specify complicating disease (reason treatment ended)
text
OffTreatmentReason,Other
Item
Specify other Reasons (reason treatment ended)
text
Item Group
Comments
Comments
Item
Comments
text
InvestigatorSignature
Item
Investigator Signature
text
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
InvestigatorSignatureDate
Item
Date
date
Item Group
Ccrr Module For E1900 Induction Treatment Form
AgentName
Item
Agent Name
text
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