ID

43436

Description

ODM derived from http://clinicaltrials.gov/show/NCT00740103

Link

http://clinicaltrials.gov/show/NCT00740103

Keywords

Versions (3)
  1. 12/6/13 12/6/13 - Martin Dugas
  2. 4/16/14 4/16/14 - Julian Varghese
  3. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00740103 Crohn's Disease

German English

Eligibility

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

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
Age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Crohn's Disease
Description

Crohn's Disease

Data type

boolean

Alias
UMLS CUI 2011AA
C0010346
SNOMED CT 2011_0131
34000006
MedDRA 14.1
10011401
ICD-10-CM Version 2010
K50.9
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
Patients satisfactorily completing study CNI-1493-04 were eligible for participation in this study. Satisfactory completion was defined as follows:
Description

Patients satisfactorily completing study CNI-1493-04 were eligible for participation in this study. Satisfactory completion was defined as follows:

Data type

boolean

Alias
UMLS CUI 2011AA
C0205170
SNOMED CT 2011_0131
20572008
UMLS CUI 2011AA
C1554962
HL7 V3 2006_05
C
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C0384938
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
The patient met all eligibility criteria for participation in study CNI-1493-04 or was granted an exemption by the medical monitor for factors indicating ineligibility
Description

The patient met all eligibility criteria for participation in study CNI-1493-04 or was granted an exemption by the medical monitor for factors indicating ineligibility

Data type

boolean

Alias
UMLS CUI 2011AA
C1550543
HL7 V3 2006_05
FLFS
UMLS CUI 2011AA
CL425202
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C0384938
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
CL414906
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0521104
SNOMED CT 2011_0131
75554001
The patient received at least 2 of the 3 planned doses of study medication.
Description

The patient received at least 2 of the 3 planned doses of study medication.

Data type

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0439091
SNOMED CT 2011_0131
276138003
HL7 V3 2006_05
GE
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0013227
The patient had no adverse event >grade 2 felt to be possibly, probably or definitely related to study medication.
Description

The patient had no adverse event >grade 2 felt to be possibly, probably or definitely related to study medication.

Data type

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0877248
MedDRA 14.1
10060933
LOINC Version 232
MTHU014542
UMLS CUI 2011AA
C0439093
SNOMED CT 2011_0131
276140008
HL7 V3 2006_05
GT
UMLS CUI 2011AA
C1522446
UMLS CUI 2011AA
C0699792
SNOMED CT 2011_0131
263498003
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0013227
The patient underwent all required evaluations, both for safety and efficacy, at baseline and day 29 and, for patients enrolling between days 43 and 57 of study CNI-1493-CD-04, at least one full later evaluation, ie the procedures required at day 43 and/or 57.
Description

The patient underwent all required evaluations, both for safety and efficacy, at baseline and day 29 and, for patients enrolling between days 43 and 57 of study CNI-1493-CD-04, at least one full later evaluation, ie the procedures required at day 43 and/or 57.

Data type

boolean

Alias
UMLS CUI 2011AA
C1556116
HL7 V3 2006_05
completed
UMLS CUI 2011AA
C0220825
UMLS CUI 2011AA
C0036043
UMLS CUI 2011AA
C1280519
SNOMED CT 2011_0131
255403003
UMLS CUI 2011AA
C1442488
At baseline for study CNI-1493-CD-05, patients were to meet the same concomitant medication criteria as for study CNI-1493-CD-04:
Description

At baseline for study CNI-1493-CD-05, patients were to meet the same concomitant medication criteria as for study CNI-1493-CD-04:

Data type

boolean

Alias
UMLS CUI 2011AA
C1550543
HL7 V3 2006_05
FLFS
UMLS CUI 2011AA
C2347852
UMLS CUI 2011AA
CL414621
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C0384938
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Patients receiving medications for CD were to be on each medication for at least 8 weeks prior to screening and on stable doses of each for at least 2 weeks prior to baseline assessments, with the following exceptions:
Description

Patients receiving medications for CD were to be on each medication for at least 8 weeks prior to screening and on stable doses of each for at least 2 weeks prior to baseline assessments, with the following exceptions:

Data type

boolean

Alias
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0010346
SNOMED CT 2011_0131
34000006
MedDRA 14.1
10011401
ICD-10-CM Version 2010
K50.9
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1442488
UMLS CUI 2011AA
C0582103
SNOMED CT 2011_0131
225886003
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
those on methotrexate were to be on a stable dose for at least 4 weeks and must not be receiving > 25mg/week
Description

those on methotrexate were to be on a stable dose for at least 4 weeks and must not be receiving > 25mg/week

Data type

boolean

Alias
UMLS CUI 2011AA
C0025677
those on azathioprine or 6-mercaptopurine on a stable dose for at least 10 weeks
Description

those on azathioprine or 6-mercaptopurine on a stable dose for at least 10 weeks

Data type

boolean

Alias
UMLS CUI 2011AA
C0004482
SNOMED CT 2011_0131
372574004
LOINC Version 232
MTHU006794
UMLS CUI 2011AA
C0000618
SNOMED CT 2011_0131
386835005
LOINC Version 232
MTHU002562
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C0205456
SNOMED CT 2011_0131
3445001
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
those on corticosteroids were to have been on them for at least 2 weeks and on a stable for those 2 weeks. They were not to be receiving > 20 mg/day prednisone (or equivalent).
Description

those on corticosteroids were to have been on them for at least 2 weeks and on a stable for those 2 weeks. They were not to be receiving > 20 mg/day prednisone (or equivalent).

Data type

boolean

Alias
UMLS CUI 2011AA
C0001617
SNOMED CT 2011_0131
79440004
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0032952
SNOMED CT 2011_0131
116602009
LOINC Version 232
MTHU003245
UMLS CUI 2011AA
CL415123
those on mesazaline were to have been on for at least 6 weeks and on a stable dose for at least 2 weeks
Description

those on mesazaline were to have been on for at least 6 weeks and on a stable dose for at least 2 weeks

Data type

boolean

Alias
UMLS CUI 2011AA
C0127615
SNOMED CT 2011_0131
387501005
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
those on antibiotics for CD were to have been on for at least 2 weeks and on a stable dose for those 2 weeks
Description

those on antibiotics for CD were to have been on for at least 2 weeks and on a stable dose for those 2 weeks

Data type

boolean

Alias
UMLS CUI 2011AA
C0003232
SNOMED CT 2011_0131
255631004
UMLS CUI 2011AA
C0010346
SNOMED CT 2011_0131
34000006
MedDRA 14.1
10011401
ICD-10-CM Version 2010
K50.9
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
Patients who were not using other CD medications were to have stopped any previous use of these agents at least 4 weeks prior to baseline assessment for study CNI-1493-CD-05.
Description

Patients who were not using other CD medications were to have stopped any previous use of these agents at least 4 weeks prior to baseline assessment for study CNI-1493-CD-05.

Data type

boolean

Alias
UMLS CUI 2011AA
C0010346
SNOMED CT 2011_0131
34000006
MedDRA 14.1
10011401
ICD-10-CM Version 2010
K50.9
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C1444662
SNOMED CT 2011_0131
410546004
UMLS CUI 2011AA
C0205450
SNOMED CT 2011_0131
9362000
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1442488
UMLS CUI 2011AA
C0582103
SNOMED CT 2011_0131
225886003
Patients were required to sign informed consent specifically for this study, in addition to the consent for study CNI-1493-CD-04.
Description

Patients were required to sign informed consent specifically for this study, in addition to the consent for study CNI-1493-CD-04.

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Men and women of childbearing potential were to be using a barrier method (diaphragm or condom) of contraception and continue doing so for at least 3 months after last study medication. It was strongly recommended that two forms be used.
Description

Men and women of childbearing potential were to be using a barrier method (diaphragm or condom) of contraception and continue doing so for at least 3 months after last study medication. It was strongly recommended that two forms be used.

Data type

boolean

Alias
UMLS CUI 2011AA
C0025266
SNOMED CT 2011_0131
339947000
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0004764
SNOMED CT 2011_0131
225370004
UMLS CUI 2011AA
C0042241
SNOMED CT 2011_0131
20359006
UMLS CUI 2011AA
C0677582
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0025663
SNOMED CT 2011_0131
260686004
LOINC Version 232
MTHU024654
UMLS CUI 2011AA
C0034866
LOINC Version 232
MTHU036724
HL7 V3 2006_05
RMD
Patients were to be able to adhere to the study visit schedule and/or protocol requirements.
Description

Patients were to be able to adhere to the study visit schedule and/or protocol requirements.

Data type

boolean

Alias
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C1321605
SNOMED CT 2011_0131
405078008
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C1512346
HL7 V3 2006_05
ENC
UMLS CUI 2011AA
C0086960
UMLS CUI 2011AA
C1709747
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Only patients completing CD04 were eligible and must not have met any of the exclusion criteria for that study.
Description

Only patients completing CD04 were eligible and must not have met any of the exclusion criteria for that study.

Data type

boolean

Alias
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C1556116
HL7 V3 2006_05
completed
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C0384938
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age at least 18 Years
Item
Age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Crohn's Disease
Item
Crohn's Disease
boolean
C0010346 (UMLS CUI 2011AA)
34000006 (SNOMED CT 2011_0131)
10011401 (MedDRA 14.1)
K50.9 (ICD-10-CM Version 2010)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
Patients satisfactorily completing study CNI-1493-04 were eligible for participation in this study. Satisfactory completion was defined as follows:
Item
Patients satisfactorily completing study CNI-1493-04 were eligible for participation in this study. Satisfactory completion was defined as follows:
boolean
C0205170 (UMLS CUI 2011AA)
20572008 (SNOMED CT 2011_0131)
C1554962 (UMLS CUI 2011AA)
C (HL7 V3 2006_05)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0384938 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
The patient met all eligibility criteria for participation in study CNI-1493-04 or was granted an exemption by the medical monitor for factors indicating ineligibility
Item
The patient met all eligibility criteria for participation in study CNI-1493-04 or was granted an exemption by the medical monitor for factors indicating ineligibility
boolean
C1550543 (UMLS CUI 2011AA)
FLFS (HL7 V3 2006_05)
CL425202 (UMLS CUI 2011AA)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0384938 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
CL414906 (UMLS CUI 2011AA)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0521104 (UMLS CUI 2011AA)
75554001 (SNOMED CT 2011_0131)
The patient received at least 2 of the 3 planned doses of study medication.
Item
The patient received at least 2 of the 3 planned doses of study medication.
boolean
C1514756 (UMLS CUI 2011AA)
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
The patient had no adverse event >grade 2 felt to be possibly, probably or definitely related to study medication.
Item
The patient had no adverse event >grade 2 felt to be possibly, probably or definitely related to study medication.
boolean
C1518422 (UMLS CUI 2011AA)
C0877248 (UMLS CUI 2011AA)
10060933 (MedDRA 14.1)
MTHU014542 (LOINC Version 232)
C0439093 (UMLS CUI 2011AA)
276140008 (SNOMED CT 2011_0131)
GT (HL7 V3 2006_05)
C1522446 (UMLS CUI 2011AA)
C0699792 (UMLS CUI 2011AA)
263498003 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
The patient underwent all required evaluations, both for safety and efficacy, at baseline and day 29 and, for patients enrolling between days 43 and 57 of study CNI-1493-CD-04, at least one full later evaluation, ie the procedures required at day 43 and/or 57.
Item
The patient underwent all required evaluations, both for safety and efficacy, at baseline and day 29 and, for patients enrolling between days 43 and 57 of study CNI-1493-CD-04, at least one full later evaluation, ie the procedures required at day 43 and/or 57.
boolean
C1556116 (UMLS CUI 2011AA)
completed (HL7 V3 2006_05)
C0220825 (UMLS CUI 2011AA)
C0036043 (UMLS CUI 2011AA)
C1280519 (UMLS CUI 2011AA)
255403003 (SNOMED CT 2011_0131)
C1442488 (UMLS CUI 2011AA)
At baseline for study CNI-1493-CD-05, patients were to meet the same concomitant medication criteria as for study CNI-1493-CD-04:
Item
At baseline for study CNI-1493-CD-05, patients were to meet the same concomitant medication criteria as for study CNI-1493-CD-04:
boolean
C1550543 (UMLS CUI 2011AA)
FLFS (HL7 V3 2006_05)
C2347852 (UMLS CUI 2011AA)
CL414621 (UMLS CUI 2011AA)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0384938 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Patients receiving medications for CD were to be on each medication for at least 8 weeks prior to screening and on stable doses of each for at least 2 weeks prior to baseline assessments, with the following exceptions:
Item
Patients receiving medications for CD were to be on each medication for at least 8 weeks prior to screening and on stable doses of each for at least 2 weeks prior to baseline assessments, with the following exceptions:
boolean
C0013227 (UMLS CUI 2011AA)
C0010346 (UMLS CUI 2011AA)
34000006 (SNOMED CT 2011_0131)
10011401 (MedDRA 14.1)
K50.9 (ICD-10-CM Version 2010)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1442488 (UMLS CUI 2011AA)
C0582103 (UMLS CUI 2011AA)
225886003 (SNOMED CT 2011_0131)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
those on methotrexate were to be on a stable dose for at least 4 weeks and must not be receiving > 25mg/week
Item
those on methotrexate were to be on a stable dose for at least 4 weeks and must not be receiving > 25mg/week
boolean
C0025677 (UMLS CUI 2011AA)
those on azathioprine or 6-mercaptopurine on a stable dose for at least 10 weeks
Item
those on azathioprine or 6-mercaptopurine on a stable dose for at least 10 weeks
boolean
C0004482 (UMLS CUI 2011AA)
372574004 (SNOMED CT 2011_0131)
MTHU006794 (LOINC Version 232)
C0000618 (UMLS CUI 2011AA)
386835005 (SNOMED CT 2011_0131)
MTHU002562 (LOINC Version 232)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0205456 (UMLS CUI 2011AA)
3445001 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
those on corticosteroids were to have been on them for at least 2 weeks and on a stable for those 2 weeks. They were not to be receiving > 20 mg/day prednisone (or equivalent).
Item
those on corticosteroids were to have been on them for at least 2 weeks and on a stable for those 2 weeks. They were not to be receiving > 20 mg/day prednisone (or equivalent).
boolean
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0032952 (UMLS CUI 2011AA)
116602009 (SNOMED CT 2011_0131)
MTHU003245 (LOINC Version 232)
CL415123 (UMLS CUI 2011AA)
those on mesazaline were to have been on for at least 6 weeks and on a stable dose for at least 2 weeks
Item
those on mesazaline were to have been on for at least 6 weeks and on a stable dose for at least 2 weeks
boolean
C0127615 (UMLS CUI 2011AA)
387501005 (SNOMED CT 2011_0131)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
those on antibiotics for CD were to have been on for at least 2 weeks and on a stable dose for those 2 weeks
Item
those on antibiotics for CD were to have been on for at least 2 weeks and on a stable dose for those 2 weeks
boolean
C0003232 (UMLS CUI 2011AA)
255631004 (SNOMED CT 2011_0131)
C0010346 (UMLS CUI 2011AA)
34000006 (SNOMED CT 2011_0131)
10011401 (MedDRA 14.1)
K50.9 (ICD-10-CM Version 2010)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
Patients who were not using other CD medications were to have stopped any previous use of these agents at least 4 weeks prior to baseline assessment for study CNI-1493-CD-05.
Item
Patients who were not using other CD medications were to have stopped any previous use of these agents at least 4 weeks prior to baseline assessment for study CNI-1493-CD-05.
boolean
C0010346 (UMLS CUI 2011AA)
34000006 (SNOMED CT 2011_0131)
10011401 (MedDRA 14.1)
K50.9 (ICD-10-CM Version 2010)
C0013227 (UMLS CUI 2011AA)
C1444662 (UMLS CUI 2011AA)
410546004 (SNOMED CT 2011_0131)
C0205450 (UMLS CUI 2011AA)
9362000 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1442488 (UMLS CUI 2011AA)
C0582103 (UMLS CUI 2011AA)
225886003 (SNOMED CT 2011_0131)
Patients were required to sign informed consent specifically for this study, in addition to the consent for study CNI-1493-CD-04.
Item
Patients were required to sign informed consent specifically for this study, in addition to the consent for study CNI-1493-CD-04.
boolean
C0021430 (UMLS CUI 2011AA)
Men and women of childbearing potential were to be using a barrier method (diaphragm or condom) of contraception and continue doing so for at least 3 months after last study medication. It was strongly recommended that two forms be used.
Item
Men and women of childbearing potential were to be using a barrier method (diaphragm or condom) of contraception and continue doing so for at least 3 months after last study medication. It was strongly recommended that two forms be used.
boolean
C0025266 (UMLS CUI 2011AA)
339947000 (SNOMED CT 2011_0131)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0004764 (UMLS CUI 2011AA)
225370004 (SNOMED CT 2011_0131)
C0042241 (UMLS CUI 2011AA)
20359006 (SNOMED CT 2011_0131)
C0677582 (UMLS CUI 2011AA)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0025663 (UMLS CUI 2011AA)
260686004 (SNOMED CT 2011_0131)
MTHU024654 (LOINC Version 232)
C0034866 (UMLS CUI 2011AA)
MTHU036724 (LOINC Version 232)
RMD (HL7 V3 2006_05)
Patients were to be able to adhere to the study visit schedule and/or protocol requirements.
Item
Patients were to be able to adhere to the study visit schedule and/or protocol requirements.
boolean
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1512346 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
C0086960 (UMLS CUI 2011AA)
C1709747 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Only patients completing CD04 were eligible and must not have met any of the exclusion criteria for that study.
Item
Only patients completing CD04 were eligible and must not have met any of the exclusion criteria for that study.
boolean
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C1556116 (UMLS CUI 2011AA)
completed (HL7 V3 2006_05)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0384938 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
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