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Eligibility Criteria

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
Is the patient 18 years old or older?
Description

Participants should be adult patients >/= 18 years of age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Does the participant have a carcinoma of the colon and/or rectum?
Description

The participant has to have carcinoma of the colon and/or rectum

Data type

boolean

Alias
UMLS CUI [1]
C0009402
Does the patient have disease progression during or within 6 months of last dose of oxaliplatin containing first-line combination therapy for metastatic disease?
Description

Disease Progression

Data type

boolean

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0069717
Does the participant have an ecog performance status of 0-1?
Description

The participant should have an ecog performance status of 0-1

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Does the participant have adequate hematological, renal and liver function?
Description

The participanthas to have adequate hematological, renal and liver function

Data type

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
Did the participant have prior treatment with monoclonal antibody/small molecule against epidermal growth factor receptor (egfr)?
Description

Prior anti-EGFR treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C1443775
UMLS CUI [1,2]
C1514463
UMLS CUI [1,3]
C4055105
Did the participant have prior treatment with irinotecan?
Description

Prior irinotecan treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0123931
Did the participant have radiotherapy within the last 4 weeks before first dose of study drug (except for limited field palliative radiotherapy for bone pain relief)?
Description

The participant should not have had radiotherapy within the last 4 weeks before first dose of study drug (except for limited field palliative radiotherapy for bone pain relief) (if so he is to be excluded)

Data type

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0332185
Does the participant have a CNS metastasis?
Description

CNS metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0686377
Does the participant have a history of or an active autoimmune disorder(s)/condition(s)?
Description

Autoimmune disorders

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0004364
UMLS CUI [2,1]
C0205177
UMLS CUI [2,2]
C0004364
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Similar models

Eligibility Criteria

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
Is the patient 18 years old or older?
boolean
C0001779 (UMLS CUI [1])
Colorectal carcinoma
Item
Does the participant have a carcinoma of the colon and/or rectum?
boolean
C0009402 (UMLS CUI [1])
Disease Progression
Item
Does the patient have disease progression during or within 6 months of last dose of oxaliplatin containing first-line combination therapy for metastatic disease?
boolean
C0242656 (UMLS CUI [1,1])
C0069717 (UMLS CUI [1,2])
ECOG Performance Status
Item
Does the participant have an ecog performance status of 0-1?
boolean
C1520224 (UMLS CUI [1])
Hematological, Renal and Liver Function
Item
Does the participant have adequate hematological, renal and liver function?
boolean
C0221130 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Prior anti-EGFR treatment
Item
Did the participant have prior treatment with monoclonal antibody/small molecule against epidermal growth factor receptor (egfr)?
boolean
C1443775 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C4055105 (UMLS CUI [1,3])
Prior irinotecan treatment
Item
Did the participant have prior treatment with irinotecan?
boolean
C1514463 (UMLS CUI [1,1])
C0123931 (UMLS CUI [1,2])
Prior Radiotherapy
Item
Did the participant have radiotherapy within the last 4 weeks before first dose of study drug (except for limited field palliative radiotherapy for bone pain relief)?
boolean
C0279134 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
CNS metastasis
Item
Does the participant have a CNS metastasis?
boolean
C0686377 (UMLS CUI [1])
Autoimmune disorders
Item
Does the participant have a history of or an active autoimmune disorder(s)/condition(s)?
boolean
C0262926 (UMLS CUI [1,1])
C0004364 (UMLS CUI [1,2])
C0205177 (UMLS CUI [2,1])
C0004364 (UMLS CUI [2,2])
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