Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age >=18 Years
Item
18 years of age, or older
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Capable of completing the diary card
Item
Capable of completing the diary card
boolean
C2698977 (UMLS CUI 2011AA)
C1554962 (UMLS CUI 2011AA)
C (HL7 V3 2006_05)
C0376660 (UMLS CUI 2011AA)
Ability to complete the HRQL questionnaires
Item
Ability to complete the HRQL questionnaires
boolean
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C1554962 (UMLS CUI 2011AA)
C0018684 (UMLS CUI 2011AA)
263775005 (SNOMED CT 2011_0131)
C0445223 (UMLS CUI 2011AA)
262094002 (SNOMED CT 2011_0131)
C0518214 (UMLS CUI 2011AA)
405152002 (SNOMED CT 2011_0131)
C0034394 (UMLS CUI 2011AA)
A clinical diagnosis of a chronic condition (e.g., osteoarthritis or rheumatoid arthritis) that requires continuous daily NSAID treatment for at least 7 months.
Item
A clinical diagnosis of a chronic condition (e.g., osteoarthritis or rheumatoid arthritis) that requires continuous daily NSAID treatment for at least 7 months.
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0332140 (UMLS CUI 2011AA)
39154008 (SNOMED CT 2011_0131)
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0029408 (UMLS CUI 2011AA)
396275006, 225655006 (SNOMED CT 2011_0131)
10031161 (MedDRA 14.1)
M19.9 (ICD-10-CM Version 2010)
715.9 (ICD-9-CM Version 2011)
C0003873 (UMLS CUI 2011AA)
69896004 (SNOMED CT 2011_0131)
10039073 (MedDRA 14.1)
M06.9 (ICD-10-CM Version 2010)
714.0 (ICD-9-CM Version 2011)
C1514873 (UMLS CUI 2011AA)
C0549178 (UMLS CUI 2011AA)
C0332173 (UMLS CUI 2011AA)
69620002 (SNOMED CT 2011_0131)
C0003211 (UMLS CUI 2011AA)
16403005 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
Daily NSAID treatment is defined as taking the prescribed dose for at least 5 of 7 days in any given week and can include COX-2 selective NSAIDs, multiple NSAIDs, and high-dose aspirin (>325 mg/day).
Item
Daily NSAID treatment is defined as taking the prescribed dose for at least 5 of 7 days in any given week and can include COX-2 selective NSAIDs, multiple NSAIDs, and high-dose aspirin (>325 mg/day).
boolean
C0332173 (UMLS CUI 2011AA)
69620002 (SNOMED CT 2011_0131)
C0003211 (UMLS CUI 2011AA)
16403005 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C1704788 (UMLS CUI 2011AA)
C0033080 (UMLS CUI 2011AA)
16076005 (SNOMED CT 2011_0131)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C1257954 (UMLS CUI 2011AA)
387050005 (SNOMED CT 2011_0131)
C0439064 (UMLS CUI 2011AA)
255204007 (SNOMED CT 2011_0131)
C0003211 (UMLS CUI 2011AA)
16403005 (SNOMED CT 2011_0131)
C0205250 (UMLS CUI 2011AA)
75540009 (SNOMED CT 2011_0131)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0004057 (UMLS CUI 2011AA)
7947003 (SNOMED CT 2011_0131)
Daily NSAID treatment dose and type: (Must have been stable for at least 4 weeks prior to baseline endoscopy and. Are expected to remain stable for the duration of the study. and. Must be administered orally for the duration of the study. If more than one type of NSAID treatment is used, at least one type must be given orally).
Item
Daily NSAID treatment dose and type: (Must have been stable for at least 4 weeks prior to baseline endoscopy and. Are expected to remain stable for the duration of the study. and. Must be administered orally for the duration of the study. If more than one type of NSAID treatment is used, at least one type must be given orally).
boolean
C0332173 (UMLS CUI 2011AA)
69620002 (SNOMED CT 2011_0131)
C0003211 (UMLS CUI 2011AA)
16403005 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0814259 (UMLS CUI 2011AA)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
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)
C0014245 (UMLS CUI 2011AA)
423827005 (SNOMED CT 2011_0131)
10014805 (MedDRA 14.1)
MTHU008659 (LOINC Version 232)
C1517001 (UMLS CUI 2011AA)
C1527428 (UMLS CUI 2011AA)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0449238 (UMLS CUI 2011AA)
103335007 (SNOMED CT 2011_0131)
MTHU001938 (LOINC Version 232)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1273553 (UMLS CUI 2011AA)
394899003 (SNOMED CT 2011_0131)
C0449238 (UMLS CUI 2011AA)
103335007 (SNOMED CT 2011_0131)
MTHU001938 (LOINC Version 232)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0814259 (UMLS CUI 2011AA)
C0003211 (UMLS CUI 2011AA)
16403005 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Current, or history of, gastric or duodenal ulcer
Item
Current, or history of, gastric or duodenal ulcer
boolean
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0038358 (UMLS CUI 2011AA)
397825006 (SNOMED CT 2011_0131)
10017822 (MedDRA 14.1)
K25 (ICD-10-CM Version 2010)
531 (ICD-9-CM Version 2011)
E10727 (CTCAE 1105E)
C0013295 (UMLS CUI 2011AA)
367474008 (SNOMED CT 2011_0131)
10013836 (MedDRA 14.1)
K26 (ICD-10-CM Version 2010)
532 (ICD-9-CM Version 2011)
E10611 (CTCAE 1105E)
Current, or history of, esophageal, gastric or duodenal surgery.
Item
Current, or history of, esophageal, gastric or duodenal surgery.
boolean
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C1522619 (UMLS CUI 2011AA)
C0038895 (UMLS CUI 2011AA)
C0192398 (UMLS CUI 2011AA)
16453004 (SNOMED CT 2011_0131)
10061969 (MedDRA 14.1)
C0013303 (UMLS CUI 2011AA)
38848004 (SNOMED CT 2011_0131)
MTHU011960 (LOINC Version 232)
C0038895 (UMLS CUI 2011AA)
History of GERD, not associated with NSAID use.
Item
History of GERD, not associated with NSAID use.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0017168 (UMLS CUI 2011AA)
235595009 (SNOMED CT 2011_0131)
10017885 (MedDRA 14.1)
K21 (ICD-10-CM Version 2010)
530.81 (ICD-9-CM Version 2011)
E10739 (CTCAE 1105E)
C1518422 (UMLS CUI 2011AA)
C0332281 (UMLS CUI 2011AA)
47429007 (SNOMED CT 2011_0131)
C0003211 (UMLS CUI 2011AA)
16403005 (SNOMED CT 2011_0131)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
Pain, discomfort or burning in the upper abdomen precipitated by exercise or relieved by defecation.
Item
Pain, discomfort or burning in the upper abdomen precipitated by exercise or relieved by defecation.
boolean
C0030193 (UMLS CUI 2011AA)
22253000 (SNOMED CT 2011_0131)
10033371 (MedDRA 14.1)
MTHU029813 (LOINC Version 232)
R52 (ICD-10-CM Version 2010)
338-338.9 (ICD-9-CM Version 2011)
E11167 (CTCAE 1105E)
CL355048 (UMLS CUI 2011AA)
247347003 (SNOMED CT 2011_0131)
C0085624 (UMLS CUI 2011AA)
90673000 (SNOMED CT 2011_0131)
10006784 (MedDRA 14.1)
C2937240 (UMLS CUI 2011AA)
80581009 (SNOMED CT 2011_0131)
C1444748 (UMLS CUI 2011AA)
410658008 (SNOMED CT 2011_0131)
C0015259 (UMLS CUI 2011AA)
256235009 (SNOMED CT 2011_0131)
10015634 (MedDRA 14.1)
C0332303 (UMLS CUI 2011AA)
1241001 (SNOMED CT 2011_0131)
C0011135 (UMLS CUI 2011AA)
39211005 (SNOMED CT 2011_0131)
Pain, discomfort or burning in the upper abdomen not associated with the use of NSAIDs, including COX-2 selective NSAIDs, as judged by the investigator.
Item
Pain, discomfort or burning in the upper abdomen not associated with the use of NSAIDs, including COX-2 selective NSAIDs, as judged by the investigator.
boolean
C0030193 (UMLS CUI 2011AA)
22253000 (SNOMED CT 2011_0131)
10033371 (MedDRA 14.1)
MTHU029813 (LOINC Version 232)
R52 (ICD-10-CM Version 2010)
338-338.9 (ICD-9-CM Version 2011)
E11167 (CTCAE 1105E)
CL355048 (UMLS CUI 2011AA)
247347003 (SNOMED CT 2011_0131)
C0085624 (UMLS CUI 2011AA)
90673000 (SNOMED CT 2011_0131)
10006784 (MedDRA 14.1)
C2937240 (UMLS CUI 2011AA)
80581009 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C0332281 (UMLS CUI 2011AA)
47429007 (SNOMED CT 2011_0131)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0003211 (UMLS CUI 2011AA)
16403005 (SNOMED CT 2011_0131)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C1257954 (UMLS CUI 2011AA)
387050005 (SNOMED CT 2011_0131)
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
CL102947 (UMLS CUI 2011AA)
Endoscopic Barrett's esophagus(>3 cm) or significant dysplastic changes in the esophagus
Item
Endoscopic Barrett's esophagus(>3 cm) or significant dysplastic changes in the esophagus
boolean
C0014245 (UMLS CUI 2011AA)
423827005 (SNOMED CT 2011_0131)
10014805 (MedDRA 14.1)
MTHU008659 (LOINC Version 232)
C2230970 (UMLS CUI 2011AA)
C1334003 (UMLS CUI 2011AA)
C27835 (ICD-10-CM Version 2010)

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