0 Ratings

ID

42735

Description

ODM derived from http://clinicaltrials.gov/show/NCT00925002

Link

http://clinicaltrials.gov/show/NCT00925002

Keywords

  1. 12/9/13 12/9/13 - Martin Dugas
  2. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY 4.0

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    Eligibility NCT00925002 ATTR-PN

    Eligibility

    1. StudyEvent: Eligibility
      1. Eligibility
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI 2011AA
    CL425202
    age 18 Years to 75 Years
    Description

    age 18 Years to 75 Years

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0001779
    SNOMED CT 2011_0131
    397669002
    ATTR-PN
    Description

    ATTR-PN

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0032923
    SNOMED CT 2011_0131
    37959007
    LOINC Version 232
    MTHU004200
    UMLS CUI 2011AA
    C0002726
    SNOMED CT 2011_0131
    17602002
    MedDRA 14.1
    10002022
    LOINC Version 232
    E85
    ICD-10-CM Version 2010
    277.3
    UMLS CUI 2011AA
    C0206247
    SNOMED CT 2011_0131
    193187004
    UMLS CUI 2011AA
    C0011900
    SNOMED CT 2011_0131
    439401001
    LOINC Version 232
    MTHU008876
    Patient has successfully completed either Protocol Fx-006 or Fx1A-201.
    Description

    Patient has successfully completed either Protocol Fx-006 or Fx1A-201.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1272703
    SNOMED CT 2011_0131
    385669000
    UMLS CUI 2011AA
    C1554962
    HL7 V3 2006_05
    C
    UMLS CUI 2011AA
    C0332152
    SNOMED CT 2011_0131
    288556008
    UMLS CUI 2011AA
    C2348563
    If female, patient is post-menopausal, surgically sterilized, or willing to use two acceptable methods of birth control (i.e., hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide) throughout the study and for 3 months from the end of the study. (A condom alone is not considered an acceptable method of birth control.)
    Description

    If female, patient is post-menopausal, surgically sterilized, or willing to use two acceptable methods of birth control (i.e., hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide) throughout the study and for 3 months from the end of the study. (A condom alone is not considered an acceptable method of birth control.)

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0086287
    SNOMED CT 2011_0131
    248152002
    HL7 V3 2006_05
    F
    UMLS CUI 2011AA
    C0232970
    SNOMED CT 2011_0131
    76498008
    UMLS CUI 2011AA
    C0543467
    SNOMED CT 2011_0131
    83578000
    MedDRA 14.1
    10051332
    LOINC Version 232
    MTHU000079
    UMLS CUI 2011AA
    C0038288
    MedDRA 14.1
    10062116
    UMLS CUI 2011AA
    C0600109
    SNOMED CT 2011_0131
    225466006
    UMLS CUI 2011AA
    C0700589
    SNOMED CT 2011_0131
    146680009
    MedDRA 14.1
    10010808
    UMLS CUI 2011AA
    CL424941
    UMLS CUI 2011AA
    C0021900
    SNOMED CT 2011_0131
    268460000
    MedDRA 14.1
    10022745
    UMLS CUI 2011AA
    C0042241
    SNOMED CT 2011_0131
    20359006
    UMLS CUI 2011AA
    C0677582
    UMLS CUI 2011AA
    C0037862
    SNOMED CT 2011_0131
    425484006
    Patient is, in the opinion of the investigator, willing and able to comply with the investigational product regimen and all other study requirements.
    Description

    Patient is, in the opinion of the investigator, willing and able to comply with the investigational product regimen and all other study requirements.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1321605
    SNOMED CT 2011_0131
    405078008
    UMLS CUI 2011AA
    C0013230
    UMLS CUI 2011AA
    CL031856
    UMLS CUI 2011AA
    C0008976
    SNOMED CT 2011_0131
    110465008
    UMLS CUI 2011AA
    C1514873
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI 2011AA
    CL425201
    Patient has not successfully completed either Protocol Fx-006 or Fx1A-201.
    Description

    Patient has not successfully completed either Protocol Fx-006 or Fx1A-201.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1518422
    UMLS CUI 2011AA
    C1272703
    SNOMED CT 2011_0131
    385669000
    UMLS CUI 2011AA
    C1554962
    HL7 V3 2006_05
    C
    UMLS CUI 2011AA
    C0332152
    SNOMED CT 2011_0131
    288556008
    UMLS CUI 2011AA
    C2348563
    Chronic use of non-protocol approved non-steroidal anti-inflammatory drugs (NSAIDs), defined as > 3 to 4 times/month. The following NSAIDs are allowed: acetylsalicylic acid, etodolac, ibuprofen, indomethicin, ketoprofen, nabumetone, naproxen, nimesulide, piroxicam, and sulindac.
    Description

    Chronic use of non-protocol approved non-steroidal anti-inflammatory drugs (NSAIDs), defined as > 3 to 4 times/month. The following NSAIDs are allowed: acetylsalicylic acid, etodolac, ibuprofen, indomethicin, ketoprofen, nabumetone, naproxen, nimesulide, piroxicam, and sulindac.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1518422
    UMLS CUI 2011AA
    C1706842
    UMLS CUI 2011AA
    C2348563
    UMLS CUI 2011AA
    C0003211
    SNOMED CT 2011_0131
    16403005, 372665008
    UMLS CUI 2011AA
    C0521104
    SNOMED CT 2011_0131
    75554001
    UMLS CUI 2011AA
    C0004057
    SNOMED CT 2011_0131
    7947003
    UMLS CUI 2011AA
    C0059865
    SNOMED CT 2011_0131
    108510003
    LOINC Version 232
    MTHU007028
    UMLS CUI 2011AA
    C0593507
    SNOMED CT 2011_0131
    387207008
    LOINC Version 232
    MTHU004262
    UMLS CUI 2011AA
    C0021246
    SNOMED CT 2011_0131
    60149003
    LOINC Version 232
    MTHU016716
    UMLS CUI 2011AA
    C0022635
    SNOMED CT 2011_0131
    10099000
    LOINC Version 232
    MTHU007198
    UMLS CUI 2011AA
    C0701331
    SNOMED CT 2011_0131
    108508000
    LOINC Version 232
    MTHU003376
    UMLS CUI 2011AA
    C0700017
    SNOMED CT 2011_0131
    11847009
    LOINC Version 232
    MTHU015374
    UMLS CUI 2011AA
    C0132515
    UMLS CUI 2011AA
    C0031990
    SNOMED CT 2011_0131
    27754002
    LOINC Version 232
    MTHU001848
    UMLS CUI 2011AA
    C0038792
    SNOMED CT 2011_0131
    89505005
    LOINC Version 232
    MTHU003386
    If female, patient is pregnant or breast feeding.
    Description

    If female, patient is pregnant or breast feeding.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0086287
    SNOMED CT 2011_0131
    248152002
    HL7 V3 2006_05
    F
    UMLS CUI 2011AA
    C0549206
    MedDRA 14.1
    10036586
    UMLS CUI 2011AA
    C0006147
    MedDRA 14.1
    10006247
    Clinically significant medical condition that, in the opinion of the investigator, would place the patient at an increased risk to participate in the study.
    Description

    Clinically significant medical condition that, in the opinion of the investigator, would place the patient at an increased risk to participate in the study.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1699700
    HL7 V3 2006_05
    MEDCCAT
    UMLS CUI 2011AA
    C0678227
    SNOMED CT 2011_0131
    23981006
    UMLS CUI 2011AA
    C0679823
    HL7 V3 2006_05
    PART
    UMLS CUI 2011AA
    C0008976
    SNOMED CT 2011_0131
    110465008
    UMLS CUI 2011AA
    C0205217
    HL7 V3 2006_05
    U
    UMLS CUI 2011AA
    C0035647
    SNOMED CT 2011_0131
    30207005
    HL7 V3 2006_05
    RSK
    The patient has received a liver or heart transplant.
    Description

    The patient has received a liver or heart transplant.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0030705
    SNOMED CT 2011_0131
    116154003
    UMLS CUI 2011AA
    C1514756
    UMLS CUI 2011AA
    C0023911
    SNOMED CT 2011_0131
    18027006
    MedDRA 14.1
    10024714
    ICD-9-CM Version 2011
    50.5
    UMLS CUI 2011AA
    C0018823
    SNOMED CT 2011_0131
    32413006
    MedDRA 14.1
    10019314
    ICD-9-CM Version 2011
    37.51

    Similar models

    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 to 75 Years
    Item
    age 18 Years to 75 Years
    boolean
    C0001779 (UMLS CUI 2011AA)
    397669002 (SNOMED CT 2011_0131)
    ATTR-PN
    Item
    ATTR-PN
    boolean
    C0032923 (UMLS CUI 2011AA)
    37959007 (SNOMED CT 2011_0131)
    MTHU004200 (LOINC Version 232)
    C0002726 (UMLS CUI 2011AA)
    17602002 (SNOMED CT 2011_0131)
    10002022 (MedDRA 14.1)
    E85 (LOINC Version 232)
    277.3 (ICD-10-CM Version 2010)
    C0206247 (UMLS CUI 2011AA)
    193187004 (SNOMED CT 2011_0131)
    C0011900 (UMLS CUI 2011AA)
    439401001 (SNOMED CT 2011_0131)
    MTHU008876 (LOINC Version 232)
    Patient has successfully completed either Protocol Fx-006 or Fx1A-201.
    Item
    Patient has successfully completed either Protocol Fx-006 or Fx1A-201.
    boolean
    C1272703 (UMLS CUI 2011AA)
    385669000 (SNOMED CT 2011_0131)
    C1554962 (UMLS CUI 2011AA)
    C (HL7 V3 2006_05)
    C0332152 (UMLS CUI 2011AA)
    288556008 (SNOMED CT 2011_0131)
    C2348563 (UMLS CUI 2011AA)
    If female, patient is post-menopausal, surgically sterilized, or willing to use two acceptable methods of birth control (i.e., hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide) throughout the study and for 3 months from the end of the study. (A condom alone is not considered an acceptable method of birth control.)
    Item
    If female, patient is post-menopausal, surgically sterilized, or willing to use two acceptable methods of birth control (i.e., hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide) throughout the study and for 3 months from the end of the study. (A condom alone is not considered an acceptable method of birth control.)
    boolean
    C0086287 (UMLS CUI 2011AA)
    248152002 (SNOMED CT 2011_0131)
    F (HL7 V3 2006_05)
    C0232970 (UMLS CUI 2011AA)
    76498008 (SNOMED CT 2011_0131)
    C0543467 (UMLS CUI 2011AA)
    83578000 (SNOMED CT 2011_0131)
    10051332 (MedDRA 14.1)
    MTHU000079 (LOINC Version 232)
    C0038288 (UMLS CUI 2011AA)
    10062116 (MedDRA 14.1)
    C0600109 (UMLS CUI 2011AA)
    225466006 (SNOMED CT 2011_0131)
    C0700589 (UMLS CUI 2011AA)
    146680009 (SNOMED CT 2011_0131)
    10010808 (MedDRA 14.1)
    CL424941 (UMLS CUI 2011AA)
    C0021900 (UMLS CUI 2011AA)
    268460000 (SNOMED CT 2011_0131)
    10022745 (MedDRA 14.1)
    C0042241 (UMLS CUI 2011AA)
    20359006 (SNOMED CT 2011_0131)
    C0677582 (UMLS CUI 2011AA)
    C0037862 (UMLS CUI 2011AA)
    425484006 (SNOMED CT 2011_0131)
    Patient is, in the opinion of the investigator, willing and able to comply with the investigational product regimen and all other study requirements.
    Item
    Patient is, in the opinion of the investigator, willing and able to comply with the investigational product regimen and all other study requirements.
    boolean
    C1321605 (UMLS CUI 2011AA)
    405078008 (SNOMED CT 2011_0131)
    C0013230 (UMLS CUI 2011AA)
    CL031856 (UMLS CUI 2011AA)
    C0008976 (UMLS CUI 2011AA)
    110465008 (SNOMED CT 2011_0131)
    C1514873 (UMLS CUI 2011AA)
    Item Group
    Exclusion Criteria
    CL425201 (UMLS CUI 2011AA)
    Patient has not successfully completed either Protocol Fx-006 or Fx1A-201.
    Item
    Patient has not successfully completed either Protocol Fx-006 or Fx1A-201.
    boolean
    C1518422 (UMLS CUI 2011AA)
    C1272703 (UMLS CUI 2011AA)
    385669000 (SNOMED CT 2011_0131)
    C1554962 (UMLS CUI 2011AA)
    C (HL7 V3 2006_05)
    C0332152 (UMLS CUI 2011AA)
    288556008 (SNOMED CT 2011_0131)
    C2348563 (UMLS CUI 2011AA)
    Chronic use of non-protocol approved non-steroidal anti-inflammatory drugs (NSAIDs), defined as > 3 to 4 times/month. The following NSAIDs are allowed: acetylsalicylic acid, etodolac, ibuprofen, indomethicin, ketoprofen, nabumetone, naproxen, nimesulide, piroxicam, and sulindac.
    Item
    Chronic use of non-protocol approved non-steroidal anti-inflammatory drugs (NSAIDs), defined as > 3 to 4 times/month. The following NSAIDs are allowed: acetylsalicylic acid, etodolac, ibuprofen, indomethicin, ketoprofen, nabumetone, naproxen, nimesulide, piroxicam, and sulindac.
    boolean
    C1518422 (UMLS CUI 2011AA)
    C1706842 (UMLS CUI 2011AA)
    C2348563 (UMLS CUI 2011AA)
    C0003211 (UMLS CUI 2011AA)
    16403005, 372665008 (SNOMED CT 2011_0131)
    C0521104 (UMLS CUI 2011AA)
    75554001 (SNOMED CT 2011_0131)
    C0004057 (UMLS CUI 2011AA)
    7947003 (SNOMED CT 2011_0131)
    C0059865 (UMLS CUI 2011AA)
    108510003 (SNOMED CT 2011_0131)
    MTHU007028 (LOINC Version 232)
    C0593507 (UMLS CUI 2011AA)
    387207008 (SNOMED CT 2011_0131)
    MTHU004262 (LOINC Version 232)
    C0021246 (UMLS CUI 2011AA)
    60149003 (SNOMED CT 2011_0131)
    MTHU016716 (LOINC Version 232)
    C0022635 (UMLS CUI 2011AA)
    10099000 (SNOMED CT 2011_0131)
    MTHU007198 (LOINC Version 232)
    C0701331 (UMLS CUI 2011AA)
    108508000 (SNOMED CT 2011_0131)
    MTHU003376 (LOINC Version 232)
    C0700017 (UMLS CUI 2011AA)
    11847009 (SNOMED CT 2011_0131)
    MTHU015374 (LOINC Version 232)
    C0132515 (UMLS CUI 2011AA)
    C0031990 (UMLS CUI 2011AA)
    27754002 (SNOMED CT 2011_0131)
    MTHU001848 (LOINC Version 232)
    C0038792 (UMLS CUI 2011AA)
    89505005 (SNOMED CT 2011_0131)
    MTHU003386 (LOINC Version 232)
    If female, patient is pregnant or breast feeding.
    Item
    If female, patient is pregnant or breast feeding.
    boolean
    C0086287 (UMLS CUI 2011AA)
    248152002 (SNOMED CT 2011_0131)
    F (HL7 V3 2006_05)
    C0549206 (UMLS CUI 2011AA)
    10036586 (MedDRA 14.1)
    C0006147 (UMLS CUI 2011AA)
    10006247 (MedDRA 14.1)
    Clinically significant medical condition that, in the opinion of the investigator, would place the patient at an increased risk to participate in the study.
    Item
    Clinically significant medical condition that, in the opinion of the investigator, would place the patient at an increased risk to participate in the study.
    boolean
    C1699700 (UMLS CUI 2011AA)
    MEDCCAT (HL7 V3 2006_05)
    C0678227 (UMLS CUI 2011AA)
    23981006 (SNOMED CT 2011_0131)
    C0679823 (UMLS CUI 2011AA)
    PART (HL7 V3 2006_05)
    C0008976 (UMLS CUI 2011AA)
    110465008 (SNOMED CT 2011_0131)
    C0205217 (UMLS CUI 2011AA)
    U (HL7 V3 2006_05)
    C0035647 (UMLS CUI 2011AA)
    30207005 (SNOMED CT 2011_0131)
    RSK (HL7 V3 2006_05)
    The patient has received a liver or heart transplant.
    Item
    The patient has received a liver or heart transplant.
    boolean
    C0030705 (UMLS CUI 2011AA)
    116154003 (SNOMED CT 2011_0131)
    C1514756 (UMLS CUI 2011AA)
    C0023911 (UMLS CUI 2011AA)
    18027006 (SNOMED CT 2011_0131)
    10024714 (MedDRA 14.1)
    50.5 (ICD-9-CM Version 2011)
    C0018823 (UMLS CUI 2011AA)
    32413006 (SNOMED CT 2011_0131)
    10019314 (MedDRA 14.1)
    37.51 (ICD-9-CM Version 2011)

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