ID

38231

Description

A Study of Capecitabine Rapid Disintegrating Tablets (RDT) Versus Commercial Xeloda in Patients With Solid Tumours; ODM derived from: https://clinicaltrials.gov/show/NCT01493336

Link

https://clinicaltrials.gov/show/NCT01493336

Keywords

Versions (1)
  1. 9/30/19 9/30/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 30, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer, Colorectal Cancer NCT01493336

English

Eligibility Breast Cancer, Colorectal Cancer NCT01493336

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients,>/= 18 years of age
Description

Adult | Age

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
histological/cytological confirmation of colorectal or breast cancer
Description

Colorectal Carcinoma | Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0009402
UMLS CUI [2]
C0678222
patient is ambulatory and has a karnofsky performance status of > 70%
Description

Patient Ambulatory | Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0439841
UMLS CUI [2]
C0206065
body surface area between 1.5 and 2.0 m2
Description

Body Surface Area

Data type

boolean

Alias
UMLS CUI [1]
C0005902
either:
Description

Either

Data type

boolean

Alias
UMLS CUI [1]
C3844638
due to receive xeloda as monotherapy or as combination therapy as per their treating physician's treatment plan, or
Description

Etiology | Xeloda | Combined Modality Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0015127
UMLS CUI [2]
C0724419
UMLS CUI [3]
C0009429
currently receiving xeloda monotherapy and in the investigator's opinion able to tolerate study drug dose on day 1 and day 2
Description

Xeloda | Ability Receive Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0724419
UMLS CUI [2,1]
C0085732
UMLS CUI [2,2]
C1514756
UMLS CUI [2,3]
C0013230
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any contraindication to xeloda
Description

Medical contraindication Xeloda

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0724419
received xeloda in the 6 days prior to day 1
Description

Xeloda Received Recently

Data type

boolean

Alias
UMLS CUI [1,1]
C0724419
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C0332185
subjects with organ allografts (other than autologous bone marrow transplant after high dose chemotherapy)
Description

Organ allografts | Exception Autologous bone marrow transplant Post High-dose chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0178784
UMLS CUI [1,2]
C0040739
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0194037
UMLS CUI [2,3]
C0687676
UMLS CUI [2,4]
C1328050
renal impairment
Description

Renal Insufficiency

Data type

boolean

Alias
UMLS CUI [1]
C1565489
pregnant or lactating females
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
participation in an investigational drug study within 28 days prior to screening
Description

Study Subject Participation Status | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
lack of physical integrity of the upper gastrointestinal tract, or clinically significant malabsorption syndrome
Description

Lacking Integrity Upper Gastrointestinal Tract | Malabsorption Syndrome

Data type

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C1947912
UMLS CUI [1,3]
C3203348
UMLS CUI [2]
C0024523
serious uncontrolled intercurrent infections
Description

Communicable Diseases Serious Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0205318
history of clinically significant coronary artery disease
Description

Coronary Artery Disease

Data type

boolean

Alias
UMLS CUI [1]
C1956346
concomitant treatment with warfarin
Description

Warfarin therapy

Data type

boolean

Alias
UMLS CUI [1]
C4303340
known dihydropyrimidine dehydrogenase deficiency
Description

Dihydropyrimidine Dehydrogenase Deficiency

Data type

boolean

Alias
UMLS CUI [1]
C1959620
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Similar models

Eligibility Breast Cancer, Colorectal Cancer NCT01493336

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult patients,>/= 18 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Colorectal Carcinoma | Breast Carcinoma
Item
histological/cytological confirmation of colorectal or breast cancer
boolean
C0009402 (UMLS CUI [1])
C0678222 (UMLS CUI [2])
Patient Ambulatory | Karnofsky Performance Status
Item
patient is ambulatory and has a karnofsky performance status of > 70%
boolean
C0030705 (UMLS CUI [1,1])
C0439841 (UMLS CUI [1,2])
C0206065 (UMLS CUI [2])
Body Surface Area
Item
body surface area between 1.5 and 2.0 m2
boolean
C0005902 (UMLS CUI [1])
Either
Item
either:
boolean
C3844638 (UMLS CUI [1])
Etiology | Xeloda | Combined Modality Therapy
Item
due to receive xeloda as monotherapy or as combination therapy as per their treating physician's treatment plan, or
boolean
C0015127 (UMLS CUI [1])
C0724419 (UMLS CUI [2])
C0009429 (UMLS CUI [3])
Xeloda | Ability Receive Investigational New Drugs
Item
currently receiving xeloda monotherapy and in the investigator's opinion able to tolerate study drug dose on day 1 and day 2
boolean
C0724419 (UMLS CUI [1])
C0085732 (UMLS CUI [2,1])
C1514756 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Xeloda
Item
any contraindication to xeloda
boolean
C1301624 (UMLS CUI [1,1])
C0724419 (UMLS CUI [1,2])
Xeloda Received Recently
Item
received xeloda in the 6 days prior to day 1
boolean
C0724419 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
Organ allografts | Exception Autologous bone marrow transplant Post High-dose chemotherapy
Item
subjects with organ allografts (other than autologous bone marrow transplant after high dose chemotherapy)
boolean
C0178784 (UMLS CUI [1,1])
C0040739 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0194037 (UMLS CUI [2,2])
C0687676 (UMLS CUI [2,3])
C1328050 (UMLS CUI [2,4])
Renal Insufficiency
Item
renal impairment
boolean
C1565489 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or lactating females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Study Subject Participation Status | Investigational New Drugs
Item
participation in an investigational drug study within 28 days prior to screening
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Lacking Integrity Upper Gastrointestinal Tract | Malabsorption Syndrome
Item
lack of physical integrity of the upper gastrointestinal tract, or clinically significant malabsorption syndrome
boolean
C0332268 (UMLS CUI [1,1])
C1947912 (UMLS CUI [1,2])
C3203348 (UMLS CUI [1,3])
C0024523 (UMLS CUI [2])
Communicable Diseases Serious Uncontrolled
Item
serious uncontrolled intercurrent infections
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
Coronary Artery Disease
Item
history of clinically significant coronary artery disease
boolean
C1956346 (UMLS CUI [1])
Warfarin therapy
Item
concomitant treatment with warfarin
boolean
C4303340 (UMLS CUI [1])
Dihydropyrimidine Dehydrogenase Deficiency
Item
known dihydropyrimidine dehydrogenase deficiency
boolean
C1959620 (UMLS CUI [1])
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