ID

18727

Description

Iressa (ZD1839) Plus Anastrozole (Arimidex) in Patients With Ovarian Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00181688

Link

https://clinicaltrials.gov/show/NCT00181688

Keywords

Versions (1)
  1. 11/17/16 11/17/16 -
Uploaded on

November 17, 2016

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Ovarian Cancer NCT00181688

English

Eligibility Ovarian Cancer NCT00181688

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologic or cytologic history diagnosis of primary ovarian, primary peritoneal or tubal carcinoma
Description

Ovarian Carcinoma Primary | Primary peritoneal carcinoma | Fallopian Tube Carcinoma Primary

Data type

boolean

Alias
UMLS CUI [1,1]
C0029925
UMLS CUI [1,2]
C0205225
UMLS CUI [2]
C1514428
UMLS CUI [3,1]
C0238122
UMLS CUI [3,2]
C0205225
asymptomatic from ovarian cancer
Description

Ovarian Carcinoma Asymptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0029925
UMLS CUI [1,2]
C0231221
evidence of recurrent ovarian, peritoneal or tubal carcinoma
Description

Ovarian cancer recurrent Evidence of | Carcinoma of peritoneum Recurrent Evidence of | Recurrent Fallopian Tube Carcinoma Evidence of

Data type

boolean

Alias
UMLS CUI [1,1]
C0278689
UMLS CUI [1,2]
C0332120
UMLS CUI [2,1]
C0948303
UMLS CUI [2,2]
C2945760
UMLS CUI [2,3]
C0332120
UMLS CUI [3,1]
C3897738
UMLS CUI [3,2]
C0332120
tumor sample must be positive for er and/or pr
Description

Tumor tissue sample Estrogen receptor positive | Tumor tissue sample Progesterone receptor positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C0279754
UMLS CUI [2,1]
C0475358
UMLS CUI [2,2]
C0279759
18 years of age or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status of less than or equal to 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
must be able to tolerate oral intake
Description

Intake Oral Ability

Data type

boolean

Alias
UMLS CUI [1,1]
C1512806
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C0085732
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
known hypersensitivity to iressa or any of the excipients of this product
Description

Hypersensitivity Iressa | Hypersensitivity Iressa Excipient

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0919281
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0919281
UMLS CUI [2,3]
C0015237
other coexisting malignancies or malignancies diagnosed within the last 5 years
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital or st. john's wort
Description

Phenytoin | Carbamazepine | Barbiturates | Rifampin | Phenobarbital | ST. JOHN'S WORT EXTRACT

Data type

boolean

Alias
UMLS CUI [1]
C0031507
UMLS CUI [2]
C0006949
UMLS CUI [3]
C0004745
UMLS CUI [4]
C0035608
UMLS CUI [5]
C0031412
UMLS CUI [6]
C0813171
treatment with a non-approved or investigational drug within 30 days
Description

Drugs, Non-Prescription | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013231
UMLS CUI [2]
C0013230
any unresolved chronic toxicity greater than ctc grad 2 from previous anticancer therapy (except alopecia)
Description

Toxicity chronic Unresolved Due to cancer treatment | CTCAE Grades | Alopecia

Data type

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0205191
UMLS CUI [1,3]
C0443342
UMLS CUI [1,4]
C0678226
UMLS CUI [1,5]
C0920425
UMLS CUI [2]
C1516728
UMLS CUI [3]
C0002170
incomplete healing from previous oncologic or other major surgery
Description

cancer surgery | major surgery | Therapeutic procedure Incomplete

Data type

boolean

Alias
UMLS CUI [1]
C0920424
UMLS CUI [2]
C0679637
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0205257
serum creatinine level greater than ctc grade 2
Description

Creatinine measurement, serum | CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C1516728
pregnant or breast feeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
severe uncontrolled systemic disease
Description

Systemic disease Uncontrolled Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C0205082
significant clinical disorder or laboratory finding that makes it potentially unsafe for the subject to participate
Description

Disease Significant At risk Study Subject Participation Status | Laboratory finding At risk Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C1444641
UMLS CUI [1,4]
C2348568
UMLS CUI [2,1]
C0587081
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C2348568
patients currently receiving other investigational antineoplastic agents, on systemic chemotherapy or under radiation therapy treatment
Description

Antineoplastic Agents Investigational | Systemic Chemotherapy | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0003392
UMLS CUI [1,2]
C1517586
UMLS CUI [2]
C1883256
UMLS CUI [3]
C1522449
patients previously treated with anastrozole or other aromatase inhibitor
Description

anastrozole | Aromatase Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0290883
UMLS CUI [2]
C0593802
unable to tolerate oral medications
Description

Oral medication Receive Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0175795
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582
clinical and/or radiographic evidence of current or impending bowel obstruction
Description

Intestinal Obstruction Evidence Clinical | Intestinal Obstruction Impending Evidence Clinical | Intestinal Obstruction Evidence roentgenographic | Intestinal Obstruction Impending Evidence roentgenographic

Data type

boolean

Alias
UMLS CUI [1,1]
C0021843
UMLS CUI [1,2]
C3887511
UMLS CUI [1,3]
C0205210
UMLS CUI [2,1]
C0021843
UMLS CUI [2,2]
C0332190
UMLS CUI [2,3]
C3887511
UMLS CUI [2,4]
C0205210
UMLS CUI [3,1]
C0021843
UMLS CUI [3,2]
C3887511
UMLS CUI [3,3]
C0034571
UMLS CUI [4,1]
C0021843
UMLS CUI [4,2]
C0332190
UMLS CUI [4,3]
C3887511
UMLS CUI [4,4]
C0034571
Back to the top of the page

Similar models

Eligibility Ovarian Cancer NCT00181688

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Ovarian Carcinoma Primary | Primary peritoneal carcinoma | Fallopian Tube Carcinoma Primary
Item
histologic or cytologic history diagnosis of primary ovarian, primary peritoneal or tubal carcinoma
boolean
C0029925 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C1514428 (UMLS CUI [2])
C0238122 (UMLS CUI [3,1])
C0205225 (UMLS CUI [3,2])
Ovarian Carcinoma Asymptomatic
Item
asymptomatic from ovarian cancer
boolean
C0029925 (UMLS CUI [1,1])
C0231221 (UMLS CUI [1,2])
Ovarian cancer recurrent Evidence of | Carcinoma of peritoneum Recurrent Evidence of | Recurrent Fallopian Tube Carcinoma Evidence of
Item
evidence of recurrent ovarian, peritoneal or tubal carcinoma
boolean
C0278689 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0948303 (UMLS CUI [2,1])
C2945760 (UMLS CUI [2,2])
C0332120 (UMLS CUI [2,3])
C3897738 (UMLS CUI [3,1])
C0332120 (UMLS CUI [3,2])
Tumor tissue sample Estrogen receptor positive | Tumor tissue sample Progesterone receptor positive
Item
tumor sample must be positive for er and/or pr
boolean
C0475358 (UMLS CUI [1,1])
C0279754 (UMLS CUI [1,2])
C0475358 (UMLS CUI [2,1])
C0279759 (UMLS CUI [2,2])
Age
Item
18 years of age or older
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status of less than or equal to 1
boolean
C1520224 (UMLS CUI [1])
Intake Oral Ability
Item
must be able to tolerate oral intake
boolean
C1512806 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Iressa | Hypersensitivity Iressa Excipient
Item
known hypersensitivity to iressa or any of the excipients of this product
boolean
C0020517 (UMLS CUI [1,1])
C0919281 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0919281 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
Malignant Neoplasms
Item
other coexisting malignancies or malignancies diagnosed within the last 5 years
boolean
C0006826 (UMLS CUI [1])
Phenytoin | Carbamazepine | Barbiturates | Rifampin | Phenobarbital | ST. JOHN'S WORT EXTRACT
Item
concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital or st. john's wort
boolean
C0031507 (UMLS CUI [1])
C0006949 (UMLS CUI [2])
C0004745 (UMLS CUI [3])
C0035608 (UMLS CUI [4])
C0031412 (UMLS CUI [5])
C0813171 (UMLS CUI [6])
Drugs, Non-Prescription | Investigational New Drugs
Item
treatment with a non-approved or investigational drug within 30 days
boolean
C0013231 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Toxicity chronic Unresolved Due to cancer treatment | CTCAE Grades | Alopecia
Item
any unresolved chronic toxicity greater than ctc grad 2 from previous anticancer therapy (except alopecia)
boolean
C0600688 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0443342 (UMLS CUI [1,3])
C0678226 (UMLS CUI [1,4])
C0920425 (UMLS CUI [1,5])
C1516728 (UMLS CUI [2])
C0002170 (UMLS CUI [3])
cancer surgery | major surgery | Therapeutic procedure Incomplete
Item
incomplete healing from previous oncologic or other major surgery
boolean
C0920424 (UMLS CUI [1])
C0679637 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C0205257 (UMLS CUI [3,2])
Creatinine measurement, serum | CTCAE Grades
Item
serum creatinine level greater than ctc grade 2
boolean
C0201976 (UMLS CUI [1])
C1516728 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnant or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Systemic disease Uncontrolled Severe
Item
severe uncontrolled systemic disease
boolean
C0442893 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
Disease Significant At risk Study Subject Participation Status | Laboratory finding At risk Study Subject Participation Status
Item
significant clinical disorder or laboratory finding that makes it potentially unsafe for the subject to participate
boolean
C0012634 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C0587081 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
Antineoplastic Agents Investigational | Systemic Chemotherapy | Therapeutic radiology procedure
Item
patients currently receiving other investigational antineoplastic agents, on systemic chemotherapy or under radiation therapy treatment
boolean
C0003392 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])
C1883256 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
anastrozole | Aromatase Inhibitors
Item
patients previously treated with anastrozole or other aromatase inhibitor
boolean
C0290883 (UMLS CUI [1])
C0593802 (UMLS CUI [2])
Oral medication Receive Unable
Item
unable to tolerate oral medications
boolean
C0175795 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Intestinal Obstruction Evidence Clinical | Intestinal Obstruction Impending Evidence Clinical | Intestinal Obstruction Evidence roentgenographic | Intestinal Obstruction Impending Evidence roentgenographic
Item
clinical and/or radiographic evidence of current or impending bowel obstruction
boolean
C0021843 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
C0021843 (UMLS CUI [2,1])
C0332190 (UMLS CUI [2,2])
C3887511 (UMLS CUI [2,3])
C0205210 (UMLS CUI [2,4])
C0021843 (UMLS CUI [3,1])
C3887511 (UMLS CUI [3,2])
C0034571 (UMLS CUI [3,3])
C0021843 (UMLS CUI [4,1])
C0332190 (UMLS CUI [4,2])
C3887511 (UMLS CUI [4,3])
C0034571 (UMLS CUI [4,4])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial