ID

28271

Beskrivning

Study ID: 100601 Clinical Study ID: LPL100601 Study Title: LPL100601, A Clinical Outcomes Study of Darapladib versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00799903 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: darapladib Study Indication: Atherosclerosis Study part: Cancer / GI Neoplasm / Polyp Report Form (CNP) - Repeating form (Scheduled visits)

Nyckelord

Versioner (6)
  1. 2017-10-02 2017-10-02 -
  2. 2017-10-04 2017-10-04 -
  3. 2017-10-04 2017-10-04 -
  4. 2017-10-13 2017-10-13 -
  5. 2017-10-23 2017-10-23 -
  6. 2018-01-01 2018-01-01 -
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GlaxoSmithKline

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1 januari 2018

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Creative Commons BY-NC 3.0
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    Cancer GI Neoplasm Polyp Report Form GSK study Chronic Coronary Heart Disease NCT00799903

    Engelsk

    Cancer GI Neoplasm Polyp Report Form GSK study Chronic Coronary Heart Disease NCT00799903

    1 Formulär  
    1. Involvement of gastrointestinal system
    Beskrivning

    1. Involvement of gastrointestinal system

    Does the cancer or polyp(s)/neoplasm(s) involve the gastrointestinal system (esophagus, stomach, small intestine, colon, anus, liver, biliary system/gall bladder or pancreas)?
    Beskrivning

    if yes, source documents must be sent to CEC

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0012240
    2. Type of cancer, GI neoplasm or GI polyp diagnosis
    Beskrivning

    2. Type of cancer, GI neoplasm or GI polyp diagnosis

    Type of cancer, GI neoplasm or GI polyp diagnosis
    Beskrivning

    Type of cancer, GI neoplasm or GI polyp diagnosis

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0516983
    UMLS CUI [1,2]
    C0221099
    UMLS CUI [1,3]
    C0017178
    3. New cancer or Recurrence or progression (2) of cancer details
    Beskrivning

    3. New cancer or Recurrence or progression (2) of cancer details

    Date of diagnosis
    Beskrivning

    Date of diagnosis

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C2316983
    Source of information supporting the diagnosis date
    Beskrivning

    Source of information supporting diagnosis date

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0683836
    Please specify procedure
    Beskrivning

    Procedure specification

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2348235
    Other, specify
    Beskrivning

    Other source of information specification

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0683836
    Site of Primary cancer
    Beskrivning

    Site of Primary cancer

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0449695
    Other site, specify
    Beskrivning

    Only complete specify box if no primary cancer site has been selected OR if 'Other gastrointestinal cancer, specify' OR 'Other cancer site, specify' OR 'Small intestinal cancer other, specify' is selected from the site list, otherwise leave blank

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C2348235
    Was metastatic (3) disease present?
    Beskrivning

    3Metastatic disease = cancer that has spread beyond primary organ (i.e. lymph nodes, contiguous structure, secondary location)

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0027627
    If yes, Locations(s) if known
    Beskrivning

    metastatic disease location

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0027627
    Other location
    Beskrivning

    metastatic disease other location

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1515974
    UMLS CUI [1,2]
    C0027627
    Other location(s), specify
    Beskrivning

    Note: If there are multiple metastatic sites, please list them in the "Other location(s), specify" section

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0872338
    UMLS CUI [1,2]
    C2348235
    4. Benign GI Polyp(s) (1), other benign GI neoplasm(s), and those neoplasms unable to be determined as benign or malignant
    Beskrivning

    4. Benign GI Polyp(s) (1), other benign GI neoplasm(s), and those neoplasms unable to be determined as benign or malignant

    Date of procedure
    Beskrivning

    Date of procedure

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C2584899
    Location of polyp(s)/neoplasm(s): Small intestine
    Beskrivning

    Location of polyp/neoplasm Small intestine

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0153425
    Location of polyp(s)/neoplasm(s): Colon
    Beskrivning

    Location of polyp/neoplasm Colon

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0009376
    UMLS CUI [1,2]
    C0450429
    Location of polyp(s)/neoplasm(s): Anus
    Beskrivning

    Location of polyp/neoplasm Anus

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0009376
    UMLS CUI [1,2]
    C0450429
    Location of polyp(s)/neoplasm(s): Stomach
    Beskrivning

    Location of polyp/neoplasm Stomach

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0009376
    UMLS CUI [1,2]
    C0450429
    Location of polyp(s)/neoplasm(s): Esophagus
    Beskrivning

    Location of polyp/neoplasm Esophagus

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0009376
    UMLS CUI [1,2]
    C0450429
    UMLS CUI [1,3]
    C0014876
    Location of polyp(s)/neoplasm(s): Biliary system
    Beskrivning

    Location of polyp/neoplasm Biliary system

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0032584
    UMLS CUI [1,2]
    C0450429
    UMLS CUI [1,3]
    C0854196
    Location of polyp(s)/neoplasm(s): Liver
    Beskrivning

    Location of polyp/neoplasm Liver

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0450429
    UMLS CUI [1,2]
    C0023884
    UMLS CUI [1,3]
    C0032584
    Location of polyp(s)/neoplasm(s): Pancreas
    Beskrivning

    Location of polyp/neoplasm Pancreas

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0030274
    UMLS CUI [1,2]
    C0032584
    Location of polyp(s)/neoplasm(s): Other
    Beskrivning

    Location of polyp/neoplasm Other

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0006826
    UMLS CUI [1,2]
    C0450429
    UMLS CUI [1,3]
    C0032584
    Other, specify
    Beskrivning

    Location of polyp/neoplasm Other specification

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C2348235
    5. Required source documents sent
    Beskrivning

    5. Required source documents sent

    Required source documents sent
    Beskrivning

    Source documents to send (source documents are required if you answered Yes to question 1): Pathology Report Operative Report Imaging study report Oncology/surgical consult notes Endoscopy Report (upper and lower) GI capsule study report Hospital Discharge Summary (if applicable)

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C1301746
    If yes, date sent:
    Beskrivning

    required source documents sent date

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C0011008
    CEC Status
    Beskrivning

    CEC Status

    6. Event number
    Beskrivning

    [read-only] Item is not required

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2826275
    7. Trigger number
    Beskrivning

    [hidden] Item is not required

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C1444748
    8. CEC Status
    Beskrivning

    [hidden]. Item is not required.

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0449438
    9. Date of status change
    Beskrivning

    [hidden]

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0443172
    10. CEC Coordinator comments
    Beskrivning

    [hidden]. Item is not required.

    Datatyp

    text

    11. Adverse event reference identifier
    Beskrivning

    Use AE Sequence number from the corresponding SAE/AE form (the last item on the form, in the "Non- Clinical" section) [hidden]. Item is not required.

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2348585
    12. Adverse event term
    Beskrivning

    Copy Adverse Event term from corresponding SAE/AE form [hidden]. Item is not required.

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2826934
    Tillbaka till toppen

    Similar models

    Cancer GI Neoplasm Polyp Report Form GSK study Chronic Coronary Heart Disease NCT00799903

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    1. Involvement of gastrointestinal system
    Item
    Does the cancer or polyp(s)/neoplasm(s) involve the gastrointestinal system (esophagus, stomach, small intestine, colon, anus, liver, biliary system/gall bladder or pancreas)?
    integer
    C0012240 (UMLS CUI [1])
    Involvement of gastrointestinal system
    Code List
    Does the cancer or polyp(s)/neoplasm(s) involve the gastrointestinal system (esophagus, stomach, small intestine, colon, anus, liver, biliary system/gall bladder or pancreas)?
    CL Item
    Primary gastrointestinal cancer or benign polyp(s)/neoplasm(s) (local only) (1)
    C3843757 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Primary gastrointestinal cancer with metastasis or spread, including lymph nodes (2)
    C0027627 (UMLS CUI-1)
    C0685938 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Non-gastrointestinal primary cancer or unknown type of primary cancer, with metastasis or spread to the gastrointestinal system (3)
    C0685938 (UMLS CUI-1)
    (Comment:en)
    CL Item
    No, not known to involve the gastrointestinal tract (4)
    C4023588 (UMLS CUI-1)
    (Comment:en)
    Item Group
    2. Type of cancer, GI neoplasm or GI polyp diagnosis
    Item
    Type of cancer, GI neoplasm or GI polyp diagnosis
    integer
    C0516983 (UMLS CUI [1,1])
    C0221099 (UMLS CUI [1,2])
    C0017178 (UMLS CUI [1,3])
    Type of cancer, GI neoplasm or GI polyp diagnosis
    Code List
    Type of cancer, GI neoplasm or GI polyp diagnosis
    CL Item
    New cancer (1)
    C0751623 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Recurrence or progression of cancer (4)
    C0277556 (UMLS CUI-1)
    (Comment:en)
    CL Item
    GI Polyp(s) or GI neoplasm(s) (benign or unknown) (6)
    C3843757 (UMLS CUI-1)
    (Comment:en)
    Item Group
    3. New cancer or Recurrence or progression (2) of cancer details
    Date of diagnosis
    Item
    Date of diagnosis
    date
    C2316983 (UMLS CUI [1])
    Item
    Source of information supporting the diagnosis date
    text
    C0683836 (UMLS CUI [1])
    Source of information supporting diagnosis date
    Code List
    Source of information supporting the diagnosis date
    CL Item
    Date of diagnostic procedure(s) - Please specify procedure (1)
    CL Item
    Date of pathology (2)
    CL Item
    Date of signs or symptoms (3)
    CL Item
    Date of death (if applicable e.g. first diagnosed on autopsy) (4)
    CL Item
    Other, specify (OT)
    Procedure specification
    Item
    Please specify procedure
    text
    C2348235 (UMLS CUI [1])
    Other source of information specification
    Item
    Other, specify
    text
    C0683836 (UMLS CUI [1])
    Item
    Site of Primary cancer
    text
    C0449695 (UMLS CUI [1])
    Site of Primary cancer
    Code List
    Site of Primary cancer
    CL Item
    Cancer of the anus (101)
    C0006826 (UMLS CUI-1)
    C0003461 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Benign non-gastrointestinal neoplasm (123)
    C0086692 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Bile duct cancer (2)
    C0005400 (UMLS CUI-1)
    C0006826 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Bladder cancer (3)
    C0005684 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Bone cancer (3b)
    C0153690 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Bowel cancer - region unknown (4b)
    C0699790 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Brain cancer (3c)
    C0153633 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Breast cancer (5)
    C0678222 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Cervical cancer (6)
    C0007847 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Colon cancer (102)
    C0699790 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Colorectal cancer (103)
    CL Item
    Endometrium (104)
    CL Item
    Esophageal cancer (105)
    CL Item
    Fallopian tube cancer (106)
    CL Item
    Gastric cancer (11)
    CL Item
    Gallbladder cancer (10)
    CL Item
    Gastrointestinal carcinoid tumor (107)
    CL Item
    Gastrointestinal stromal tumor (GIST) (108)
    CL Item
    Hodgkin's disease with gastrointestinal involvement (110)
    CL Item
    Hodgkin's diasease with no gastrointestinal involvement (109)
    CL Item
    Larynx cancer (111)
    CL Item
    Leukemia (13)
    CL Item
    Lip cancer (14)
    CL Item
    Liver cancer (15)
    CL Item
    Lung cancer (16)
    CL Item
    Lymphoma gastric origin (112)
    CL Item
    Lymphoma small intestinal origin (113)
    CL Item
    Lymphoma other gastrointestinal (114)
    CL Item
    Lymphoma non-gastrointestinal (115)
    CL Item
    Mesothelioma (116a)
    CL Item
    Multiple myeloma (18)
    C0026764 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Myelodysplastic syndrome (19)
    C3463824 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Oral cancer (21)
    C0153381 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Ovarian cancer (22)
    C0029925 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Pancreatic cancer (23)
    C0235974 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Penis cancer (24)
    C0153601 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Pharyngeal cancer (25)
    C0153405 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Prostate cancer (26)
    C0600139 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Rectal cancer (117)
    C0009402 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Renal cancer (27)
    C1378703 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Scrotum cancer (28)
    C0153604 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Skin cancer, melanoma (29a)
    C0007114 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Skin cancer non-melanoma (29b)
    C0677898 (UMLS CUI-1)
    C0699893 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Small Intestinal adenocarcinoma (118)
    C0278803 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Small intestinal carcinoid tumors (120)
    C0007095 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Small Intestinal sarcoma (119)
    C1336007 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Small intestinal cancer other, specify (121)
    C0346627 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Spinal cord (125)
    C0037925 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Testicular cancer (30)
    C0153594 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Thyroid cancer (122)
    C0007115 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Unknown primary cancer (126)
    C0027667 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Uterine, other site (127)
    C1515974 (UMLS CUI-1)
    C0205394 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Vaginal cancer (31)
    C0042237 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Vulval cancer (32)
    C0375071 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Other gastrointestinal cancer, specify (129A)
    C0810319 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Other cancer site, specify (129)
    C0006826 (UMLS CUI-1)
    C2945843 (UMLS CUI-2)
    (Comment:en)
    Other site specification
    Item
    Other site, specify
    text
    C0205394 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    metastatic disease
    Item
    Was metastatic (3) disease present?
    boolean
    C0027627 (UMLS CUI [1])
    Item
    If yes, Locations(s) if known
    integer
    C0027627 (UMLS CUI [1])
    metastatic disease location
    Code List
    If yes, Locations(s) if known
    CL Item
    Anus (1)
    C0003461 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Bile duct (2)
    C0005400 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Bladder (3)
    C0005682 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Bone (4)
    C0262950 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Bone marrow (5)
    C0005953 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Bowel - region unknown (6)
    C0021853 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Brain (7)
    C0006104 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Breast (8)
    C0006141 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Cervix (9)
    C0007874 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Colon (10)
    C0009368 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Endometrium (11)
    CL Item
    Esophagus (12)
    CL Item
    Eye (13)
    CL Item
    Fallopian tube (14)
    CL Item
    Gall bladder (15)
    CL Item
    Kidney (16)
    CL Item
    Larynx (17)
    CL Item
    Lip (18)
    CL Item
    Liver (19)
    CL Item
    Lung (20)
    CL Item
    Lymph node(s) (21)
    CL Item
    Mouth (22)
    CL Item
    Ovary (23)
    CL Item
    Pancreas (24)
    CL Item
    Penis (25)
    CL Item
    Pharynx (26)
    CL Item
    Prostate (27)
    CL Item
    Rectum (28)
    CL Item
    Scrotum (29)
    CL Item
    Skin (30)
    CL Item
    Small intestine (31)
    CL Item
    Spinal cord (32)
    CL Item
    Stomach (33)
    CL Item
    Testes (34)
    CL Item
    Thyroid (35)
    CL Item
    Vagina (36)
    CL Item
    Vulva (37)
    metastatic disease other location
    Item
    Other location
    boolean
    C1515974 (UMLS CUI [1,1])
    C0027627 (UMLS CUI [1,2])
    metastatic disease other location specification
    Item
    Other location(s), specify
    text
    C0872338 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Item Group
    4. Benign GI Polyp(s) (1), other benign GI neoplasm(s), and those neoplasms unable to be determined as benign or malignant
    Date of procedure
    Item
    Date of procedure
    date
    C2584899 (UMLS CUI [1])
    Location of polyp/neoplasm Small intestine
    Item
    Location of polyp(s)/neoplasm(s): Small intestine
    boolean
    C0153425 (UMLS CUI [1])
    Location of polyp/neoplasm Colon
    Item
    Location of polyp(s)/neoplasm(s): Colon
    boolean
    C0009376 (UMLS CUI [1,1])
    C0450429 (UMLS CUI [1,2])
    Location of polyp/neoplasm Anus
    Item
    Location of polyp(s)/neoplasm(s): Anus
    boolean
    C0009376 (UMLS CUI [1,1])
    C0450429 (UMLS CUI [1,2])
    Location of polyp/neoplasm Stomach
    Item
    Location of polyp(s)/neoplasm(s): Stomach
    boolean
    C0009376 (UMLS CUI [1,1])
    C0450429 (UMLS CUI [1,2])
    Location of polyp/neoplasm Esophagus
    Item
    Location of polyp(s)/neoplasm(s): Esophagus
    boolean
    C0009376 (UMLS CUI [1,1])
    C0450429 (UMLS CUI [1,2])
    C0014876 (UMLS CUI [1,3])
    Location of polyp/neoplasm Biliary system
    Item
    Location of polyp(s)/neoplasm(s): Biliary system
    boolean
    C0032584 (UMLS CUI [1,1])
    C0450429 (UMLS CUI [1,2])
    C0854196 (UMLS CUI [1,3])
    Location of polyp/neoplasm Liver
    Item
    Location of polyp(s)/neoplasm(s): Liver
    boolean
    C0450429 (UMLS CUI [1,1])
    C0023884 (UMLS CUI [1,2])
    C0032584 (UMLS CUI [1,3])
    Location of polyp/neoplasm Pancreas
    Item
    Location of polyp(s)/neoplasm(s): Pancreas
    boolean
    C0030274 (UMLS CUI [1,1])
    C0032584 (UMLS CUI [1,2])
    Location of polyp/neoplasm Other
    Item
    Location of polyp(s)/neoplasm(s): Other
    boolean
    C0006826 (UMLS CUI [1,1])
    C0450429 (UMLS CUI [1,2])
    C0032584 (UMLS CUI [1,3])
    Location of polyp/neoplasm Other specification
    Item
    Other, specify
    text
    C0205394 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Item Group
    5. Required source documents sent
    Item
    Required source documents sent
    text
    C1301746 (UMLS CUI [1])
    Required source documents sent
    Code List
    Required source documents sent
    CL Item
    Yes (Y)
    CL Item
    Not available (NV)
    CL Item
    Source documents not required - case does not require adjudication (i.e. non-GI cancer/neoplasm) (NR)
    required source documents sent date
    Item
    If yes, date sent:
    date
    C0011008 (UMLS CUI [1])
    Item Group
    CEC Status
    Event number
    Item
    6. Event number
    text
    C2826275 (UMLS CUI [1])
    Trigger number
    Item
    7. Trigger number
    text
    C1444748 (UMLS CUI [1])
    Item
    8. CEC Status
    integer
    C0449438 (UMLS CUI [1])
    CEC Status
    Code List
    8. CEC Status
    CL Item
    New (1)
    C0205314 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Coordinator Screen check (2)
    C1710220 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Hold (3)
    C1948035 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Ready for review (4)
    C3166277 (UMLS CUI-1)
    (Comment:en)
    CL Item
    In Phase I review (5)
    (Comment:en)
    CL Item
    Queried (InForm) (6)
    (Comment:en)
    CL Item
    Additional documents required (7)
    (Comment:en)
    CL Item
    In Phase II committee (8)
    (Comment:en)
    CL Item
    Data change (9)
    C0011008 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Re-Review (10)
    (Comment:en)
    CL Item
    Completed event (11)
    CL Item
    No event to adjudicate (12)
    CL Item
    QC Random sample (13)
    CL Item
    In Translation (14)
    Date of status change
    Item
    9. Date of status change
    date
    C0011008 (UMLS CUI [1,1])
    C0443172 (UMLS CUI [1,2])
    CEC Coordinator comments
    Item
    10. CEC Coordinator comments
    text
    Adverse event reference identifier
    Item
    11. Adverse event reference identifier
    text
    C1519255 (UMLS CUI [1,1])
    C2348585 (UMLS CUI [1,2])
    Adverse event term
    Item
    12. Adverse event term
    text
    C2826934 (UMLS CUI [1])
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