ID

3730

Description

ODM derived from http://clinicaltrials.gov/show/NCT01283724

Link

http://clinicaltrials.gov/show/NCT01283724

Keywords

  1. 2/28/13 2/28/13 - Martin Dugas
  2. 9/20/21 9/20/21 -
Uploaded on

February 28, 2013

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.

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 NCT01283724 Endometriosis

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

age 12 Years to 17 Years
Description

age 12 Years to 17 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Female adolescents after menarche (12 - < 18 years of age) at screening. For Finland: Adolescents aged 12 - 14 years old who present with clinical features of endometriosis will only be enrolled into the study if their diagnosis of endometriosis has been confirmed by laparoscopy.
Description

Female adolescents after menarche (12 - < 18 years of age) at screening. For Finland: Adolescents aged 12 - 14 years old who present with clinical features of endometriosis will only be enrolled into the study if their diagnosis of endometriosis has been confirmed by laparoscopy.

Data type

boolean

Alias
UMLS CUI 2011AA
C0001588
UMLS CUI 2011AA
C0231290
SNOMED CT 2011_0131
237679004
UMLS CUI 2011AA
C0025274
SNOMED CT 2011_0131
20016009
MedDRA 14.1
10027182
UMLS CUI 2011AA
C1409616
UMLS CUI 2011AA
C0016132
SNOMED CT 2011_0131
223665002
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
UMLS CUI 2011AA
C0750484
UMLS CUI 2011AA
C0031150
SNOMED CT 2011_0131
73632009
MedDRA 14.1
10023693
ICD-9-CM Version 2011
54.21
UMLS CUI 2011AA
C0014175
SNOMED CT 2011_0131
396224008
MedDRA 14.1
10014778
ICD-10-CM Version 2010
N80
ICD-9-CM Version 2011
617
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
Dysmenorrhea of at least moderate intensity, with or without chronic pelvic pain, for at least 2 cycles in the previous 4 months and one of the following conditions:
Description

Dysmenorrhea of at least moderate intensity, with or without chronic pelvic pain, for at least 2 cycles in the previous 4 months and one of the following conditions:

Data type

boolean

Alias
UMLS CUI 2011AA
C0013390
SNOMED CT 2011_0131
266599000
MedDRA 14.1
10013935
ICD-10-CM Version 2010
N94.6
ICD-9-CM Version 2011
625.3
CTCAE 1105E
E13077
UMLS CUI 2011AA
C0439091
SNOMED CT 2011_0131
276138003
HL7 V3 2006_05
GE
UMLS CUI 2011AA
C1881878
UMLS CUI 2011AA
C0522510
SNOMED CT 2011_0131
103370009
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C0404484
SNOMED CT 2011_0131
237067000
Clinically suspected endometriosis based on the presence of pelvic pain incompletely relieved by non steroidal anti-inflammatory drugs and/or oral contraceptives
Description

Clinically suspected endometriosis based on the presence of pelvic pain incompletely relieved by non steroidal anti-inflammatory drugs and/or oral contraceptives

Data type

boolean

Alias
UMLS CUI 2011AA
C0750491
SNOMED CT 2011_0131
415684004
UMLS CUI 2011AA
C0014175
SNOMED CT 2011_0131
396224008
MedDRA 14.1
10014778
ICD-10-CM Version 2010
N80
ICD-9-CM Version 2011
617
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C0850758
MedDRA 14.1
10048581
UMLS CUI 2011AA
C0205257
SNOMED CT 2011_0131
255599008
UMLS CUI 2011AA
C0332303
SNOMED CT 2011_0131
1241001
UMLS CUI 2011AA
C0003211
SNOMED CT 2011_0131
16403005, 372665008
UMLS CUI 2011AA
C0009905
SNOMED CT 2011_0131
59261009
Any abdominal pain associated with ultrasound findings suggestive of endometriosis (abdominal, vaginal or rectal - only after additional specific consent and assent)
Description

Any abdominal pain associated with ultrasound findings suggestive of endometriosis (abdominal, vaginal or rectal - only after additional specific consent and assent)

Data type

boolean

Alias
UMLS CUI 2011AA
C0000737
SNOMED CT 2011_0131
21522001
MedDRA 14.1
10000081
LOINC Version 232
MTHU013636
ICD-10-CM Version 2010
R10.9
ICD-9-CM Version 2011
789.0
CTCAE 1105E
E10460
UMLS CUI 2011AA
C0332281
SNOMED CT 2011_0131
47429007
UMLS CUI 2011AA
C1299966
SNOMED CT 2011_0131
370380004
UMLS CUI 2011AA
C0038659
UMLS CUI 2011AA
C0014175
SNOMED CT 2011_0131
396224008
MedDRA 14.1
10014778
ICD-10-CM Version 2010
N80
ICD-9-CM Version 2011
617
UMLS CUI 2011AA
C2348813
UMLS CUI 2011AA
C0203418
SNOMED CT 2011_0131
13205008
MedDRA 14.1
10052603
UMLS CUI 2011AA
C1112240
MedDRA 14.1
10056619
Failure of surgical treatment for endometriosis (with cyclic or chronic pelvic pain of at least 4 months duration postsurgery)
Description

Failure of surgical treatment for endometriosis (with cyclic or chronic pelvic pain of at least 4 months duration postsurgery)

Data type

boolean

Alias
UMLS CUI 2011AA
C0231174
SNOMED CT 2011_0131
76797004
UMLS CUI 2011AA
C0543467
SNOMED CT 2011_0131
83578000
MedDRA 14.1
10051332
LOINC Version 232
MTHU000079
UMLS CUI 2011AA
C0014175
SNOMED CT 2011_0131
396224008
MedDRA 14.1
10014778
ICD-10-CM Version 2010
N80
ICD-9-CM Version 2011
617
UMLS CUI 2011AA
C0260698
ICD-10-CM Version 2010
Z98
ICD-9-CM Version 2011
V45.89
UMLS CUI 2011AA
C0439596
SNOMED CT 2011_0131
44180009
UMLS CUI 2011AA
C0850758
MedDRA 14.1
10048581
UMLS CUI 2011AA
C0404484
SNOMED CT 2011_0131
237067000
Threshold for endometriosis-associated pelvic pain (EAPP) score: at least 30 on a 100 units visual analog scale retrospectively evaluated at screening for the last 4 weeks
Description

Threshold for endometriosis-associated pelvic pain (EAPP) score: at least 30 on a 100 units visual analog scale retrospectively evaluated at screening for the last 4 weeks

Data type

boolean

Alias
UMLS CUI 2011AA
C0449864
SNOMED CT 2011_0131
118589004
UMLS CUI 2011AA
C0850758
MedDRA 14.1
10048581
UMLS CUI 2011AA
C0332281
SNOMED CT 2011_0131
47429007
UMLS CUI 2011AA
C0014175
SNOMED CT 2011_0131
396224008
MedDRA 14.1
10014778
ICD-10-CM Version 2010
N80
ICD-9-CM Version 2011
617
UMLS CUI 2011AA
C0042815
SNOMED CT 2011_0131
273903006
Exclusion Criteria
Description

Exclusion Criteria

Absence of endometriosis at laparoscopy
Description

Absence of endometriosis at laparoscopy

Data type

boolean

Alias
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C0014175
SNOMED CT 2011_0131
396224008
MedDRA 14.1
10014778
ICD-10-CM Version 2010
N80
ICD-9-CM Version 2011
617
UMLS CUI 2011AA
C0031150
SNOMED CT 2011_0131
73632009
MedDRA 14.1
10023693
ICD-9-CM Version 2011
54.21
Previous application of hormonal agents including oral contraceptives within 2 months, progestins, danazol within 3 months, and Gonadotropin Releasing Hormone (GnRH) agonists within 6 months prior to start of treatment
Description

Previous application of hormonal agents including oral contraceptives within 2 months, progestins, danazol within 3 months, and Gonadotropin Releasing Hormone (GnRH) agonists within 6 months prior to start of treatment

Data type

boolean

Alias
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
CL025718
UMLS CUI 2011AA
C0019928
SNOMED CT 2011_0131
22091006
UMLS CUI 2011AA
C0009905
SNOMED CT 2011_0131
59261009
UMLS CUI 2011AA
C0033306
SNOMED CT 2011_0131
116614001, 20249007
UMLS CUI 2011AA
C0010961
SNOMED CT 2011_0131
87881000
UMLS CUI 2011AA
C1521755
UMLS CUI 2011AA
C0243192
Chronic pelvic pain that might be related to genitourinary disease or to chronic or recurrent gastrointestinal disease, including irritable bowel syndrome (defined as a disease characterized by pain relieved by defecation and irregular defecation patterns lasting at least 3 months)
Description

Chronic pelvic pain that might be related to genitourinary disease or to chronic or recurrent gastrointestinal disease, including irritable bowel syndrome (defined as a disease characterized by pain relieved by defecation and irregular defecation patterns lasting at least 3 months)

Data type

boolean

Alias
UMLS CUI 2011AA
C0404484
SNOMED CT 2011_0131
237067000
UMLS CUI 2011AA
C0699792
SNOMED CT 2011_0131
263498003
UMLS CUI 2011AA
C1720887
UMLS CUI 2011AA
C0017178
SNOMED CT 2011_0131
119292006
MedDRA 14.1
10017944
UMLS CUI 2011AA
C0022104
SNOMED CT 2011_0131
10743008
MedDRA 14.1
10023003
ICD-10-CM Version 2010
K58
ICD-9-CM Version 2011
564.1
Clinically established need for primary surgical treatment of endometriosis
Description

Clinically established need for primary surgical treatment of endometriosis

Data type

boolean

Alias
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C0686904
SNOMED CT 2011_0131
103325001
UMLS CUI 2011AA
CL414904
UMLS CUI 2011AA
C0543467
SNOMED CT 2011_0131
83578000
MedDRA 14.1
10051332
LOINC Version 232
MTHU000079
UMLS CUI 2011AA
C0014175
SNOMED CT 2011_0131
396224008
MedDRA 14.1
10014778
ICD-10-CM Version 2010
N80
ICD-9-CM Version 2011
617

Similar models

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
age 12 Years to 17 Years
Item
age 12 Years to 17 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Female adolescents after menarche (12 - < 18 years of age) at screening. For Finland: Adolescents aged 12 - 14 years old who present with clinical features of endometriosis will only be enrolled into the study if their diagnosis of endometriosis has been confirmed by laparoscopy.
Item
Female adolescents after menarche (12 - < 18 years of age) at screening. For Finland: Adolescents aged 12 - 14 years old who present with clinical features of endometriosis will only be enrolled into the study if their diagnosis of endometriosis has been confirmed by laparoscopy.
boolean
C0001588 (UMLS CUI 2011AA)
C0231290 (UMLS CUI 2011AA)
237679004 (SNOMED CT 2011_0131)
C0025274 (UMLS CUI 2011AA)
20016009 (SNOMED CT 2011_0131)
10027182 (MedDRA 14.1)
C1409616 (UMLS CUI 2011AA)
C0016132 (UMLS CUI 2011AA)
223665002 (SNOMED CT 2011_0131)
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
C0750484 (UMLS CUI 2011AA)
C0031150 (UMLS CUI 2011AA)
73632009 (SNOMED CT 2011_0131)
10023693 (MedDRA 14.1)
54.21 (ICD-9-CM Version 2011)
C0014175 (UMLS CUI 2011AA)
396224008 (SNOMED CT 2011_0131)
10014778 (MedDRA 14.1)
N80 (ICD-10-CM Version 2010)
617 (ICD-9-CM Version 2011)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
Dysmenorrhea of at least moderate intensity, with or without chronic pelvic pain, for at least 2 cycles in the previous 4 months and one of the following conditions:
Item
Dysmenorrhea of at least moderate intensity, with or without chronic pelvic pain, for at least 2 cycles in the previous 4 months and one of the following conditions:
boolean
C0013390 (UMLS CUI 2011AA)
266599000 (SNOMED CT 2011_0131)
10013935 (MedDRA 14.1)
N94.6 (ICD-10-CM Version 2010)
625.3 (ICD-9-CM Version 2011)
E13077 (CTCAE 1105E)
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C1881878 (UMLS CUI 2011AA)
C0522510 (UMLS CUI 2011AA)
103370009 (SNOMED CT 2011_0131)
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0404484 (UMLS CUI 2011AA)
237067000 (SNOMED CT 2011_0131)
Clinically suspected endometriosis based on the presence of pelvic pain incompletely relieved by non steroidal anti-inflammatory drugs and/or oral contraceptives
Item
Clinically suspected endometriosis based on the presence of pelvic pain incompletely relieved by non steroidal anti-inflammatory drugs and/or oral contraceptives
boolean
C0750491 (UMLS CUI 2011AA)
415684004 (SNOMED CT 2011_0131)
C0014175 (UMLS CUI 2011AA)
396224008 (SNOMED CT 2011_0131)
10014778 (MedDRA 14.1)
N80 (ICD-10-CM Version 2010)
617 (ICD-9-CM Version 2011)
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0850758 (UMLS CUI 2011AA)
10048581 (MedDRA 14.1)
C0205257 (UMLS CUI 2011AA)
255599008 (SNOMED CT 2011_0131)
C0332303 (UMLS CUI 2011AA)
1241001 (SNOMED CT 2011_0131)
C0003211 (UMLS CUI 2011AA)
16403005, 372665008 (SNOMED CT 2011_0131)
C0009905 (UMLS CUI 2011AA)
59261009 (SNOMED CT 2011_0131)
Any abdominal pain associated with ultrasound findings suggestive of endometriosis (abdominal, vaginal or rectal - only after additional specific consent and assent)
Item
Any abdominal pain associated with ultrasound findings suggestive of endometriosis (abdominal, vaginal or rectal - only after additional specific consent and assent)
boolean
C0000737 (UMLS CUI 2011AA)
21522001 (SNOMED CT 2011_0131)
10000081 (MedDRA 14.1)
MTHU013636 (LOINC Version 232)
R10.9 (ICD-10-CM Version 2010)
789.0 (ICD-9-CM Version 2011)
E10460 (CTCAE 1105E)
C0332281 (UMLS CUI 2011AA)
47429007 (SNOMED CT 2011_0131)
C1299966 (UMLS CUI 2011AA)
370380004 (SNOMED CT 2011_0131)
C0038659 (UMLS CUI 2011AA)
C0014175 (UMLS CUI 2011AA)
396224008 (SNOMED CT 2011_0131)
10014778 (MedDRA 14.1)
N80 (ICD-10-CM Version 2010)
617 (ICD-9-CM Version 2011)
C2348813 (UMLS CUI 2011AA)
C0203418 (UMLS CUI 2011AA)
13205008 (SNOMED CT 2011_0131)
10052603 (MedDRA 14.1)
C1112240 (UMLS CUI 2011AA)
10056619 (MedDRA 14.1)
Failure of surgical treatment for endometriosis (with cyclic or chronic pelvic pain of at least 4 months duration postsurgery)
Item
Failure of surgical treatment for endometriosis (with cyclic or chronic pelvic pain of at least 4 months duration postsurgery)
boolean
C0231174 (UMLS CUI 2011AA)
76797004 (SNOMED CT 2011_0131)
C0543467 (UMLS CUI 2011AA)
83578000 (SNOMED CT 2011_0131)
10051332 (MedDRA 14.1)
MTHU000079 (LOINC Version 232)
C0014175 (UMLS CUI 2011AA)
396224008 (SNOMED CT 2011_0131)
10014778 (MedDRA 14.1)
N80 (ICD-10-CM Version 2010)
617 (ICD-9-CM Version 2011)
C0260698 (UMLS CUI 2011AA)
Z98 (ICD-10-CM Version 2010)
V45.89 (ICD-9-CM Version 2011)
C0439596 (UMLS CUI 2011AA)
44180009 (SNOMED CT 2011_0131)
C0850758 (UMLS CUI 2011AA)
10048581 (MedDRA 14.1)
C0404484 (UMLS CUI 2011AA)
237067000 (SNOMED CT 2011_0131)
Threshold for endometriosis-associated pelvic pain (EAPP) score: at least 30 on a 100 units visual analog scale retrospectively evaluated at screening for the last 4 weeks
Item
Threshold for endometriosis-associated pelvic pain (EAPP) score: at least 30 on a 100 units visual analog scale retrospectively evaluated at screening for the last 4 weeks
boolean
C0449864 (UMLS CUI 2011AA)
118589004 (SNOMED CT 2011_0131)
C0850758 (UMLS CUI 2011AA)
10048581 (MedDRA 14.1)
C0332281 (UMLS CUI 2011AA)
47429007 (SNOMED CT 2011_0131)
C0014175 (UMLS CUI 2011AA)
396224008 (SNOMED CT 2011_0131)
10014778 (MedDRA 14.1)
N80 (ICD-10-CM Version 2010)
617 (ICD-9-CM Version 2011)
C0042815 (UMLS CUI 2011AA)
273903006 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
Absence of endometriosis at laparoscopy
Item
Absence of endometriosis at laparoscopy
boolean
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0014175 (UMLS CUI 2011AA)
396224008 (SNOMED CT 2011_0131)
10014778 (MedDRA 14.1)
N80 (ICD-10-CM Version 2010)
617 (ICD-9-CM Version 2011)
C0031150 (UMLS CUI 2011AA)
73632009 (SNOMED CT 2011_0131)
10023693 (MedDRA 14.1)
54.21 (ICD-9-CM Version 2011)
Previous application of hormonal agents including oral contraceptives within 2 months, progestins, danazol within 3 months, and Gonadotropin Releasing Hormone (GnRH) agonists within 6 months prior to start of treatment
Item
Previous application of hormonal agents including oral contraceptives within 2 months, progestins, danazol within 3 months, and Gonadotropin Releasing Hormone (GnRH) agonists within 6 months prior to start of treatment
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
CL025718 (UMLS CUI 2011AA)
C0019928 (UMLS CUI 2011AA)
22091006 (SNOMED CT 2011_0131)
C0009905 (UMLS CUI 2011AA)
59261009 (SNOMED CT 2011_0131)
C0033306 (UMLS CUI 2011AA)
116614001, 20249007 (SNOMED CT 2011_0131)
C0010961 (UMLS CUI 2011AA)
87881000 (SNOMED CT 2011_0131)
C1521755 (UMLS CUI 2011AA)
C0243192 (UMLS CUI 2011AA)
Chronic pelvic pain that might be related to genitourinary disease or to chronic or recurrent gastrointestinal disease, including irritable bowel syndrome (defined as a disease characterized by pain relieved by defecation and irregular defecation patterns lasting at least 3 months)
Item
Chronic pelvic pain that might be related to genitourinary disease or to chronic or recurrent gastrointestinal disease, including irritable bowel syndrome (defined as a disease characterized by pain relieved by defecation and irregular defecation patterns lasting at least 3 months)
boolean
C0404484 (UMLS CUI 2011AA)
237067000 (SNOMED CT 2011_0131)
C0699792 (UMLS CUI 2011AA)
263498003 (SNOMED CT 2011_0131)
C1720887 (UMLS CUI 2011AA)
C0017178 (UMLS CUI 2011AA)
119292006 (SNOMED CT 2011_0131)
10017944 (MedDRA 14.1)
C0022104 (UMLS CUI 2011AA)
10743008 (SNOMED CT 2011_0131)
10023003 (MedDRA 14.1)
K58 (ICD-10-CM Version 2010)
564.1 (ICD-9-CM Version 2011)
Clinically established need for primary surgical treatment of endometriosis
Item
Clinically established need for primary surgical treatment of endometriosis
boolean
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0686904 (UMLS CUI 2011AA)
103325001 (SNOMED CT 2011_0131)
CL414904 (UMLS CUI 2011AA)
C0543467 (UMLS CUI 2011AA)
83578000 (SNOMED CT 2011_0131)
10051332 (MedDRA 14.1)
MTHU000079 (LOINC Version 232)
C0014175 (UMLS CUI 2011AA)
396224008 (SNOMED CT 2011_0131)
10014778 (MedDRA 14.1)
N80 (ICD-10-CM Version 2010)
617 (ICD-9-CM Version 2011)

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

Fields marked with * are required.

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