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Long NameOff Treatment NCI Standard Template
DefinitionThe collection of CDEs used in the off treatment module.
ContextcaBIG
Protocol Long NameNCI Standard Template Forms
WorkflowRELEASED
TypeCRF
Public ID3476130
Version1.0
Module Long NameModule InstructionsQuestionCDECDE Public IDCDE VersionValue Domain Data TypeValue Domain Unit of MeasureDisplay FormatValid ValueForm Value Meaning TextForm Value Meaning Desc.
Mandatory Off Treatment Questions These items must be included when this data is collected for reporting.
Off Intervention DateOff Treatment Date233.0DATEMM/DD/YYYY
Off Treatment ReasonOff-treatment Code24532191.0CHARACTER
01Treatment completed per protocol criteriaTreatment completed per protocol criteria
02Disease progression, relapse during active treatmentDisease progression, relapse during active treatment
03Adverse event/side effects/complicationsAdverse event/side effects/complications
04DEATH ON STUDYDEATH ON STUDY
05Patient withdrawal/refusal after beginning protocol therapyPatient withdrawal/refusal after beginning protocol therapy [patient refused to continue protocol therapy for reasons other than side effects, Adverse Event, or complications (e.g., cost, travel)].
06Patient withdrawal/refusal prior to beginning a protocol therapyPatient withdrawal/refusal prior to beginning a protocol therapy
07Alternative TherapyAlternative Therapy
08PATIENT OFF-TREATMENT FOR OTHER COMPLICATING DISEASEPATIENT OFF-TREATMENT FOR OTHER COMPLICATING DISEASE
10Lost to Follow-upNo value exists.
11Cytogenetic resistanceCytogenetic resistance
12Disease progression before active treatmentDisease progression before active treatment
13No treatment, per protocol criteriaNo treatment, per protocol criteria
98OtherNot otherwise specified.
Off Treatment Other, SpecifyOff Treatment Reason Specify29568701.0CHARACTER