ID

20183

Beschrijving

CONCEPT: Comparison of Oxaliplatin vs Conventional Methods With Calcium/Magnesium in First-Line Metastatic Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00129870

Link

https://clinicaltrials.gov/show/NCT00129870

Trefwoorden

Versies (1)
  1. 10-02-17 10-02-17 -
Geüploaded op

10 februari 2017

DOI

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Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT00129870

Engels

Eligibility Colorectal Cancer NCT00129870

1 Formulieren  
Criteria
Beschrijving

Criteria

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically documented metastatic, measurable adenocarcinoma of the colon, rectum, or appendix with no prior therapies for metastatic disease
Beschrijving

Adenocarcinoma of colon metastatic Measurable | Adenocarcinoma of rectum metastatic Measurable | Adenocarcinoma of appendix metastatic Measurable | Neoplasm Metastasis untreated

Datatype

boolean

Alias
UMLS CUI [1,1]
C0338106
UMLS CUI [1,2]
C1522484
UMLS CUI [1,3]
C1513040
UMLS CUI [2,1]
C0149978
UMLS CUI [2,2]
C1522484
UMLS CUI [2,3]
C1513040
UMLS CUI [3,1]
C0238003
UMLS CUI [3,2]
C1522484
UMLS CUI [3,3]
C1513040
UMLS CUI [4,1]
C0027627
UMLS CUI [4,2]
C0332155
ecog performance status (ps) of 0 or 1
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
adequate hematologic, renal, and hepatic function as defined by required baseline laboratory parameters
Beschrijving

Hematologic function | Renal function | Liver function

Datatype

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
no other serious concomitant disease.
Beschrijving

Comorbidity Serious Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0332197
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
peripheral neuropathy > grade 1 at baseline
Beschrijving

Peripheral Neuropathy CTCAE Grades

Datatype

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
history of significant cerebrovascular, cardiovascular, or peripheral vascular disease
Beschrijving

Cerebrovascular Disorders | Cardiovascular Diseases | Peripheral Vascular Diseases

Datatype

boolean

Alias
UMLS CUI [1]
C0007820
UMLS CUI [2]
C0007222
UMLS CUI [3]
C0085096
uncontrolled hypertension (defined as blood pressure > 150/100 mmhg)
Beschrijving

Uncontrolled hypertension | Blood pressure determination

Datatype

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0005824
history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess, within 6 months prior to start of study drug
Beschrijving

abdominal fistula | Gastrointestinal perforation | Abdominal Abscess

Datatype

boolean

Alias
UMLS CUI [1]
C1879311
UMLS CUI [2]
C0151664
UMLS CUI [3]
C0243001
minor surgical procedure, fine needle aspiration, or core biopsy within 7 days prior to start of study drug
Beschrijving

Minor Surgical Procedures | Fine needle aspiration biopsy | Core needle biopsy

Datatype

boolean

Alias
UMLS CUI [1]
C0038904
UMLS CUI [2]
C1510483
UMLS CUI [3]
C1318309
serious, non-healing wound, ulcer, or bone fracture
Beschrijving

Non-healed Wound Serious | Non-healed Ulcer Serious | Non-healed Fracture Serious

Datatype

boolean

Alias
UMLS CUI [1,1]
C0750433
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0041582
UMLS CUI [2,2]
C0205301
UMLS CUI [2,3]
C0205404
UMLS CUI [3,1]
C0016658
UMLS CUI [3,2]
C0205301
UMLS CUI [3,3]
C0205404
active gastroduodenal ulcer
Beschrijving

Peptic Ulcer

Datatype

boolean

Alias
UMLS CUI [1]
C0030920
evidence of bleeding diathesis or coagulopathy
Beschrijving

Bleeding tendency Evidence of | Blood Coagulation Disorders Evidence of

Datatype

boolean

Alias
UMLS CUI [1,1]
C1458140
UMLS CUI [1,2]
C0332120
UMLS CUI [2,1]
C0005779
UMLS CUI [2,2]
C0332120
significant history of bleeding within 6 months prior to registration
Beschrijving

Hemorrhage

Datatype

boolean

Alias
UMLS CUI [1]
C0019080
prior history of hypertensive crisis or hypertensive encephalopathy
Beschrijving

Hypertensive crisis | Hypertensive Encephalopathy

Datatype

boolean

Alias
UMLS CUI [1]
C0020546
UMLS CUI [2]
C0151620
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Similar models

Eligibility Colorectal Cancer NCT00129870

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of colon metastatic Measurable | Adenocarcinoma of rectum metastatic Measurable | Adenocarcinoma of appendix metastatic Measurable | Neoplasm Metastasis untreated
Item
histologically or cytologically documented metastatic, measurable adenocarcinoma of the colon, rectum, or appendix with no prior therapies for metastatic disease
boolean
C0338106 (UMLS CUI [1,1])
C1522484 (UMLS CUI [1,2])
C1513040 (UMLS CUI [1,3])
C0149978 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
C1513040 (UMLS CUI [2,3])
C0238003 (UMLS CUI [3,1])
C1522484 (UMLS CUI [3,2])
C1513040 (UMLS CUI [3,3])
C0027627 (UMLS CUI [4,1])
C0332155 (UMLS CUI [4,2])
ECOG performance status
Item
ecog performance status (ps) of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Hematologic function | Renal function | Liver function
Item
adequate hematologic, renal, and hepatic function as defined by required baseline laboratory parameters
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Comorbidity Serious Absent
Item
no other serious concomitant disease.
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Peripheral Neuropathy CTCAE Grades
Item
peripheral neuropathy > grade 1 at baseline
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Cerebrovascular Disorders | Cardiovascular Diseases | Peripheral Vascular Diseases
Item
history of significant cerebrovascular, cardiovascular, or peripheral vascular disease
boolean
C0007820 (UMLS CUI [1])
C0007222 (UMLS CUI [2])
C0085096 (UMLS CUI [3])
Uncontrolled hypertension | Blood pressure determination
Item
uncontrolled hypertension (defined as blood pressure > 150/100 mmhg)
boolean
C1868885 (UMLS CUI [1])
C0005824 (UMLS CUI [2])
abdominal fistula | Gastrointestinal perforation | Abdominal Abscess
Item
history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess, within 6 months prior to start of study drug
boolean
C1879311 (UMLS CUI [1])
C0151664 (UMLS CUI [2])
C0243001 (UMLS CUI [3])
Minor Surgical Procedures | Fine needle aspiration biopsy | Core needle biopsy
Item
minor surgical procedure, fine needle aspiration, or core biopsy within 7 days prior to start of study drug
boolean
C0038904 (UMLS CUI [1])
C1510483 (UMLS CUI [2])
C1318309 (UMLS CUI [3])
Non-healed Wound Serious | Non-healed Ulcer Serious | Non-healed Fracture Serious
Item
serious, non-healing wound, ulcer, or bone fracture
boolean
C0750433 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0041582 (UMLS CUI [2,1])
C0205301 (UMLS CUI [2,2])
C0205404 (UMLS CUI [2,3])
C0016658 (UMLS CUI [3,1])
C0205301 (UMLS CUI [3,2])
C0205404 (UMLS CUI [3,3])
Peptic Ulcer
Item
active gastroduodenal ulcer
boolean
C0030920 (UMLS CUI [1])
Bleeding tendency Evidence of | Blood Coagulation Disorders Evidence of
Item
evidence of bleeding diathesis or coagulopathy
boolean
C1458140 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0005779 (UMLS CUI [2,1])
C0332120 (UMLS CUI [2,2])
Hemorrhage
Item
significant history of bleeding within 6 months prior to registration
boolean
C0019080 (UMLS CUI [1])
Hypertensive crisis | Hypertensive Encephalopathy
Item
prior history of hypertensive crisis or hypertensive encephalopathy
boolean
C0020546 (UMLS CUI [1])
C0151620 (UMLS CUI [2])
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