0 Evaluaciones
ID

45974

Descripción

The general purpose of this trial is to investigate the efficacy and safety of 4 dose strategies of BIBF 1120 treatment for 12 months, compared to placebo in patients with idiopathic pulmonary fibrosis. The primary objective of this study is to demonstrate whether at least one dose strategy is superior to placebo in patients with IPF, in modifying the rate of decline of Forced Vital Capacity (FVC). As a secondary objective, additional parameters will be assessed in order to differentiate between dose strategies on the basis of safety and efficacy

Link

NCT00514683

Palabras clave

Versiones (3)
  1. 5/3/24 5/3/24 - Dr. Christian Niklas
  2. 28/3/24 28/3/24 - Dr. Christian Niklas
  3. 28/3/24 28/3/24 - Dr. Christian Niklas
Titular de derechos de autor

Boehringer Ingelheim

Subido en

28 de marzo de 2024

DOI

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Licencia

Creative Commons BY-NC-SA 4.0
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    Safety And Efficacy of BIBF 1120 in Idiopathic Pulmonary Fibrosis

    Inglés

    Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD

    352 formularios  
    1. StudyEvent: CUM_AE
      1. Description: Adverse Event | Help Text: (S)
      2. Description: Physical Examination ECOG score only | Help Text: (P)
      3. Description: Concomitant Therapies | Help Text: (S)
      4. Description: Areterial Blood Gases
      5. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    2. StudyEvent: CUM_CT
      1. Description: Concomitant Therapies | Help Text: (S)
      2. Description: Study Medication (BIBF)
      3. Description: Adverse Event | Help Text: (S)
      4. Description: Termination of Period/Trial Medication | Help Text: (S)
      5. Description: Administration of BIBF Before | Help Text: (P) PKADM
      6. Description: Medication Compliance
      7. Description: Patient Eligibility | Help Text: (S)
    3. StudyEvent: TRT CHANGE
      1. Description: Study Medication (BIBF)
    4. StudyEvent: IVRS
      1. Description: Information from IVRS
    5. StudyEvent: VISIT 1
      1. Description: Patient Demographics | Help Text: (S)
      2. Description: Physical Examination (Screening) | Help Text: (P)
      3. Description: Concomitant Diagnosis / Baseline Conditions | Help Text: (S)
      4. Description: Six minutes walking test
      5. Description: Lab samples taken | Help Text: (O)
      6. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
      7. Description: Pregnancy test | Help Text: (P)
      8. Description: ECG at screening | Help Text: (P)
      9. Description: Lab samples taken | Help Text: (O)
      10. Description: Lab Batch | Help Text: (O)
      11. Description: Pulmonary Function Testing | Help Text: (P)
      12. Description: Diagnosis of IPF
      13. Description: Inclusion/Exclusion Criteria | Help Text: (S)
      14. Description: Patient Eligibility | Help Text: (S)
      15. Description: Physical Examination ECOG score only | Help Text: (P)
      16. Description: Determination of DLco
      17. Description: Areterial Blood Gases
      18. Description: Concomitant Therapies | Help Text: (S)
      19. Description: Lab samples taken | Help Text: (O)
      20. Description: St. George's Respiratory Questionnaire | Help Text: (P)
      21. Description: Medical research council dyspnoea score
      22. Description: Physical Examination (except V3 V5) | Help Text: (P)
      23. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
      24. Description: Substance measurement at time point | Help Text: (P)
      25. Description: Pharmacokinetic parameter PD | Help Text: (P)
    6. StudyEvent: VISIT 2
      1. Description: Diagnosis of IPF
      2. Description: Physical Examination (except V3 V5) | Help Text: (P)
      3. Description: St. George's Respiratory Questionnaire | Help Text: (P)
      4. Description: Medical research council dyspnoea score
      5. Description: Lab samples taken | Help Text: (O)
      6. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
      7. Description: genetic informed conset
      8. Description: Pregnancy test | Help Text: (P)
      9. Description: Lab samples taken | Help Text: (O)
      10. Description: Pulmonary Function Testing | Help Text: (P)
      11. Description: Determination of DLco
      12. Description: Areterial Blood Gases
      13. Description: Six minutes walking test
      14. Description: Inclusion/Exclusion Criteria | Help Text: (S)
      15. Description: Patient Eligibility | Help Text: (S)
      16. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
      17. Description: Administration of BIBF now (not used) | Help Text: (P) PKADM
      18. Description: Lab Batch | Help Text: (O)
      19. Description: Pulmonary Function Testing | Help Text: (P)
      20. Description: Administration of BIBF now | Help Text: (P) PKADM
      21. Description: Concomitant Therapies | Help Text: (S)
      22. Description: Assigned Medication Number(s) from Label(s)
      23. Description: Assigned Medication Number(s) from Label(s)
      24. Description: Substance measurement at time point | Help Text: (P)
      25. Description: Pharmacokinetic parameter | Help Text: (P)
      26. Description: Pharmacokinetic parameter PD | Help Text: (P)
    7. StudyEvent: VISIT 3
      1. Description: Medication Compliance
      2. Description: Physical Examination ECOG score only | Help Text: (P)
      3. Description: ECG | Help Text: (P)
      4. Description: Lab samples taken | Help Text: (O)
      5. Description: Lab samples taken | Help Text: (O)
      6. Description: Pulmonary Function Testing | Help Text: (P)
      7. Description: Lab Batch | Help Text: (O)
      8. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
      9. Description: Substance measurement at time point | Help Text: (P)
    8. StudyEvent: VISIT 4
      1. Description: Medication Compliance
      2. Description: Administration of BIBF Before (not used) | Help Text: (P) PKADM
      3. Description: Physical Examination (except V3 V5) | Help Text: (P)
      4. Description: ECG | Help Text: (P)
      5. Description: Lab samples taken | Help Text: (O)
      6. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
      7. Description: Lab samples taken | Help Text: (O)
      8. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
      9. Description: Assigned Medication Number(s) from Label(s)
      10. Description: Lab Batch | Help Text: (O)
      11. Description: Administration of BIBF now (not used) | Help Text: (P) PKADM
      12. Description: Pulmonary Function Testing | Help Text: (P)
      13. Description: Administration of BIBF Before | Help Text: (P) PKADM
      14. Description: Administration of BIBF now | Help Text: (P) PKADM
      15. Description: genetic informed conset
      16. Description: Substance measurement at time point | Help Text: (P)
      17. Description: Pharmacokinetic parameter | Help Text: (P)
      18. Description: Pharmacokinetic parameter PD | Help Text: (P)
    9. StudyEvent: VISIT 5
      1. Description: Medication Compliance
      2. Description: Physical Examination ECOG score only | Help Text: (P)
      3. Description: Lab samples taken | Help Text: (O)
      4. Description: Lab samples taken | Help Text: (O)
      5. Description: Lab Batch | Help Text: (O)
      6. Description: Pulmonary Function Testing | Help Text: (P)
      7. Description: Administration of BIBF now | Help Text: (P) PKADM
      8. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
      9. Description: Administration of BIBF Before | Help Text: (P) PKADM
      10. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
      11. Description: Substance measurement at time point | Help Text: (P)
    10. StudyEvent: VISIT 6
      1. Description: Medication Compliance
      2. Description: Physical Examination (except V3 V5) | Help Text: (P)
      3. Description: St. George's Respiratory Questionnaire | Help Text: (P)
      4. Description: Medical research council dyspnoea score
      5. Description: ECG | Help Text: (P)
      6. Description: Lab samples taken | Help Text: (O)
      7. Description: Pregnancy test | Help Text: (P)
      8. Description: Lab samples taken | Help Text: (O)
      9. Description: Assigned Medication Number(s) from Label(s)
      10. Description: Lab Batch | Help Text: (O)
      11. Description: Pulmonary Function Testing | Help Text: (P)
      12. Description: Adverse Event | Help Text: (S)
      13. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
      14. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
      15. Description: Administration of BIBF now | Help Text: (P) PKADM
      16. Description: Substance measurement at time point | Help Text: (P)
    11. StudyEvent: VISIT 6A
      1. Description: Lab samples taken | Help Text: (O)
      2. Description: Lab Batch | Help Text: (O)
      3. Description: Six minutes walking test
      4. Description: Areterial Blood Gases
      5. Description: Pulmonary Function Testing | Help Text: (P)
      6. Description: Determination of DLco
      7. Description: Pulmonary Function Testing | Help Text: (P)
    12. StudyEvent: VISIT 7
      1. Description: Medication Compliance
      2. Description: Administration of BIBF Before | Help Text: (P) PKADM
      3. Description: Physical Examination (except V3 V5) | Help Text: (P)
      4. Description: St. George's Respiratory Questionnaire | Help Text: (P)
      5. Description: Medical research council dyspnoea score
      6. Description: ECG | Help Text: (P)
      7. Description: Lab samples taken | Help Text: (O)
      8. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
      9. Description: Pregnancy test | Help Text: (P)
      10. Description: Lab samples taken | Help Text: (O)
      11. Description: Pulmonary Function Testing | Help Text: (P)
      12. Description: Six minutes walking test
      13. Description: Determination of DLco
      14. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
      15. Description: Administration of BIBF now | Help Text: (P) PKADM
      16. Description: Assigned Medication Number(s) from Label(s)
      17. Description: Lab Batch | Help Text: (O)
      18. Description: Pulmonary Function Testing | Help Text: (P)
      19. Description: Areterial Blood Gases
      20. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
      21. Description: Substance measurement at time point | Help Text: (P)
      22. Description: Pharmacokinetic parameter | Help Text: (P)
      23. Description: Pharmacokinetic parameter PD | Help Text: (P)
    13. StudyEvent: VISIT 7A
      1. Description: Lab samples taken | Help Text: (O)
      2. Description: Lab Batch | Help Text: (O)
      3. Description: Six minutes walking test
      4. Description: Pulmonary Function Testing | Help Text: (P)
      5. Description: Determination of DLco
    14. StudyEvent: VISIT 8
      1. Description: Medication Compliance
      2. Description: Physical Examination (except V3 V5) | Help Text: (P)
      3. Description: ECG | Help Text: (P)
      4. Description: Lab samples taken | Help Text: (O)
      5. Description: Pregnancy test | Help Text: (P)
      6. Description: Lab samples taken | Help Text: (O)
      7. Description: Assigned Medication Number(s) from Label(s)
      8. Description: Lab Batch | Help Text: (O)
      9. Description: Pulmonary Function Testing | Help Text: (P)
      10. Description: Determination of DLco
      11. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
      12. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
      13. Description: Substance measurement at time point | Help Text: (P)
    15. StudyEvent: VISIT 8A
      1. Description: Lab Batch | Help Text: (O)
      2. Description: Lab samples taken | Help Text: (O)
      3. Description: Physical Examination ECOG score only | Help Text: (P)
      4. Description: Pulmonary Function Testing | Help Text: (P)
    16. StudyEvent: VISIT 9
      1. Description: Medication Compliance
      2. Description: Administration of BIBF Before | Help Text: (P) PKADM
      3. Description: Physical Examination (except V3 V5) | Help Text: (P)
      4. Description: St. George's Respiratory Questionnaire | Help Text: (P)
      5. Description: Medical research council dyspnoea score
      6. Description: Lab samples taken | Help Text: (O)
      7. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
      8. Description: Pregnancy test | Help Text: (P)
      9. Description: Lab samples taken | Help Text: (O)
      10. Description: Pulmonary Function Testing | Help Text: (P)
      11. Description: Six minutes walking test
      12. Description: Determination of DLco
      13. Description: Areterial Blood Gases
      14. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
      15. Description: Administration of BIBF now | Help Text: (P) PKADM
      16. Description: Lab Batch | Help Text: (O)
      17. Description: Pulmonary Function Testing | Help Text: (P)
      18. Description: ECG | Help Text: (P)
      19. Description: Substance measurement at time point | Help Text: (P)
      20. Description: Pharmacokinetic parameter | Help Text: (P)
      21. Description: Pharmacokinetic parameter PD | Help Text: (P)
    17. StudyEvent: END TRT 1
      1. Description: Termination of Period/Trial Medication | Help Text: (S)
      2. Description: Assigned Medication Number(s) from Label(s)
      3. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    18. StudyEvent: VISIT 10
      1. Description: Administration of BIBF Before | Help Text: (P) PKADM
      2. Description: Medication Compliance
      3. Description: Physical Examination (except V3 V5) | Help Text: (P)
      4. Description: ECG | Help Text: (P)
      5. Description: Lab samples taken | Help Text: (O)
      6. Description: Pregnancy test | Help Text: (P)
      7. Description: Lab samples taken | Help Text: (O)
      8. Description: Lab Batch | Help Text: (O)
      9. Description: Pulmonary Function Testing | Help Text: (P)
      10. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
      11. Description: Substance measurement at time point | Help Text: (P)
    19. StudyEvent: VISIT 11
      1. Description: Medication Compliance
      2. Description: Physical Examination (except V3 V5) | Help Text: (P)
      3. Description: ECG | Help Text: (P)
      4. Description: Lab samples taken | Help Text: (O)
      5. Description: Pregnancy test | Help Text: (P)
      6. Description: Lab samples taken | Help Text: (O)
      7. Description: Assigned Medication Number(s) from Label(s)
      8. Description: Pulmonary Function Testing | Help Text: (P)
      9. Description: Lab Batch | Help Text: (O)
      10. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
      11. Description: Substance measurement at time point | Help Text: (P)
    20. StudyEvent: VISIT 12
      1. Description: Medication Compliance
      2. Description: Physical Examination (except V3 V5) | Help Text: (P)
      3. Description: ECG | Help Text: (P)
      4. Description: Lab samples taken | Help Text: (O)
      5. Description: Pregnancy test | Help Text: (P)
      6. Description: Lab samples taken | Help Text: (O)
      7. Description: Assigned Medication Number(s) from Label(s)
      8. Description: Pulmonary Function Testing | Help Text: (P)
      9. Description: Lab Batch | Help Text: (O)
      10. Description: Pulmonary Function Testing | Help Text: (P)
      11. Description: Areterial Blood Gases
      12. Description: Determination of DLco
      13. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
      14. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
      15. Description: Substance measurement at time point | Help Text: (P)
    21. StudyEvent: VISIT 12A
      1. Description: Lab Batch | Help Text: (O)
      2. Description: Lab samples taken | Help Text: (O)
      3. Description: ECG | Help Text: (P)
      4. Description: Lab samples taken | Help Text: (O)
      5. Description: Pulmonary Function Testing | Help Text: (P)
    22. StudyEvent: VISIT 13
      1. Description: Medication Compliance
      2. Description: Physical Examination (except V3 V5) | Help Text: (P)
      3. Description: ECG | Help Text: (P)
      4. Description: Lab samples taken | Help Text: (O)
      5. Description: Pregnancy test | Help Text: (P)
      6. Description: Lab samples taken | Help Text: (O)
      7. Description: Determination of DLco
      8. Description: Assigned Medication Number(s) from Label(s)
      9. Description: Pulmonary Function Testing | Help Text: (P)
      10. Description: Lab Batch | Help Text: (O)
      11. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
      12. Description: Substance measurement at time point | Help Text: (P)
    23. StudyEvent: VISIT 13A
      1. Description: Lab samples taken | Help Text: (O)
      2. Description: Lab Batch | Help Text: (O)
      3. Description: ECG | Help Text: (P)
    24. StudyEvent: VISIT 13B
      1. Description: Lab samples taken | Help Text: (O)
      2. Description: Lab Batch | Help Text: (O)
    25. StudyEvent: VISIT 13C
      1. Description: Lab Batch | Help Text: (O)
      2. Description: Lab samples taken | Help Text: (O)
      3. Description: Concomitant Therapies | Help Text: (S)
      4. Description: Physical Examination ECOG score only | Help Text: (P)
    26. StudyEvent: VISIT 14
      1. Description: Medication Compliance
      2. Description: Physical Examination (except V3 V5) | Help Text: (P)
      3. Description: ECG | Help Text: (P)
      4. Description: Lab samples taken | Help Text: (O)
      5. Description: Pregnancy test | Help Text: (P)
      6. Description: Lab samples taken | Help Text: (O)
      7. Description: Determination of DLco
      8. Description: Assigned Medication Number(s) from Label(s)
      9. Description: Pulmonary Function Testing | Help Text: (P)
      10. Description: Lab Batch | Help Text: (O)
    27. StudyEvent: VISIT 14A
      1. Description: Lab samples taken | Help Text: (O)
      2. Description: Lab Batch | Help Text: (O)
    28. StudyEvent: VISIT 14B
      1. Description: Lab samples taken | Help Text: (O)
      2. Description: Lab Batch | Help Text: (O)
      3. Description: Pulmonary Function Testing | Help Text: (P)
    29. StudyEvent: VISIT 14C
      1. Description: Lab samples taken | Help Text: (O)
      2. Description: Lab Batch | Help Text: (O)
    30. StudyEvent: VISIT 15
      1. Description: Medication Compliance
      2. Description: Physical Examination (except V3 V5) | Help Text: (P)
      3. Description: ECG | Help Text: (P)
      4. Description: Lab samples taken | Help Text: (O)
      5. Description: Pregnancy test | Help Text: (P)
      6. Description: Lab samples taken | Help Text: (O)
      7. Description: Determination of DLco
      8. Description: Assigned Medication Number(s) from Label(s)
      9. Description: Lab Batch | Help Text: (O)
      10. Description: Pulmonary Function Testing | Help Text: (P)
    31. StudyEvent: VISIT 15A
      1. Description: Lab Batch | Help Text: (O)
      2. Description: Lab samples taken | Help Text: (O)
    32. StudyEvent: VISIT 15B
      1. Description: Lab samples taken | Help Text: (O)
      2. Description: Lab Batch | Help Text: (O)
    33. StudyEvent: VISIT 15C
      1. Description: Lab samples taken | Help Text: (O)
      2. Description: Lab Batch | Help Text: (O)
    34. StudyEvent: VISIT 16
      1. Description: Medication Compliance
      2. Description: Physical Examination (except V3 V5) | Help Text: (P)
      3. Description: ECG | Help Text: (P)
      4. Description: Lab samples taken | Help Text: (O)
      5. Description: Pregnancy test | Help Text: (P)
      6. Description: Lab samples taken | Help Text: (O)
      7. Description: Determination of DLco
      8. Description: Assigned Medication Number(s) from Label(s)
      9. Description: Pulmonary Function Testing | Help Text: (P)
      10. Description: Lab Batch | Help Text: (O)
    35. StudyEvent: VISIT 16A
      1. Description: Lab samples taken | Help Text: (O)
      2. Description: Lab Batch | Help Text: (O)
    36. StudyEvent: VISIT 16B
      1. Description: Lab samples taken | Help Text: (O)
      2. Description: Lab Batch | Help Text: (O)
    37. StudyEvent: VISIT 16C
      1. Description: Lab samples taken | Help Text: (O)
      2. Description: Lab Batch | Help Text: (O)
    38. StudyEvent: END TRT 2
      1. Description: Termination of Period/Trial Medication | Help Text: (S)
      2. Description: Patient Vital Status | Help Text: (O)
    39. StudyEvent: EOT
      1. Description: Medication Compliance
      2. Description: Physical Examination (except V3 V5) | Help Text: (P)
      3. Description: ECG | Help Text: (P)
      4. Description: Lab samples taken | Help Text: (O)
      5. Description: Pregnancy test | Help Text: (P)
      6. Description: Lab samples taken | Help Text: (O)
      7. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
      8. Description: Lab Batch | Help Text: (O)
      9. Description: Pulmonary Function Testing | Help Text: (P)
      10. Description: St. George's Respiratory Questionnaire | Help Text: (P)
      11. Description: Medical research council dyspnoea score
      12. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
      13. Description: Pulmonary Function Testing | Help Text: (P)
      14. Description: Six minutes walking test
      15. Description: Determination of DLco
      16. Description: Areterial Blood Gases
      17. Description: Substance measurement at time point | Help Text: (P)
    40. StudyEvent: FOLLOWUP
      1. Description: Physical Examination (except V3 V5) | Help Text: (P)
      2. Description: Patient Vital Status | Help Text: (O)
      3. Description: Lab samples taken | Help Text: (O)
    41. StudyEvent: DISC V4
      1. Description: Physical Examination ECOG score only | Help Text: (P)
      2. Description: Lab samples taken | Help Text: (O)
      3. Description: Pulmonary Function Testing | Help Text: (P)
    42. StudyEvent: DISC V5
      1. Description: Physical Examination ECOG score only | Help Text: (P)
      2. Description: Lab samples taken | Help Text: (O)
      3. Description: Pulmonary Function Testing | Help Text: (P)
    43. StudyEvent: DISC V6
      1. Description: Physical Examination ECOG score only | Help Text: (P)
      2. Description: Lab samples taken | Help Text: (O)
      3. Description: Pulmonary Function Testing | Help Text: (P)
    44. StudyEvent: DISC V7
      1. Description: Physical Examination ECOG score only | Help Text: (P)
      2. Description: Lab samples taken | Help Text: (O)
      3. Description: Pulmonary Function Testing | Help Text: (P)
    45. StudyEvent: DISC V8
      1. Description: Physical Examination ECOG score only | Help Text: (P)
      2. Description: Lab samples taken | Help Text: (O)
      3. Description: Pulmonary Function Testing | Help Text: (P)
      4. Description: Lab samples taken | Help Text: (O)
    46. StudyEvent: DISC V9
      1. Description: Physical Examination ECOG score only | Help Text: (P)
      2. Description: Lab samples taken | Help Text: (O)
      3. Description: Pulmonary Function Testing | Help Text: (P)
      4. Description: Pulmonary Function Testing | Help Text: (P)
    47. StudyEvent: COMPLETION
      1. Description: Trial Completion | Help Text: (O)
      2. Description: Patient Vital Status | Help Text: (O)
      3. Description: Physical Examination ECOG score only | Help Text: (P)
    BLD
    Descripción

    BLD

    Alias
    UMLS CUI [1,1]
    C0005834 (Collection of blood specimen for laboratory procedure)
    SNOMED
    82078001
    LOINC
    LP125037-4
    Locked
    Descripción

    LOCKED

    Tipo de datos

    text

    Alias
    UMLS CUI [1, 1]
    C3244297 (locked)
    Lab and lab range subset
    Descripción

    LAB

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0022877 (Laboratory)
    SNOMED
    261904005
    LOINC
    MTHU029808
    UMLS CUI [2,1]
    C0022877 (Laboratory)
    SNOMED
    261904005
    LOINC
    MTHU029808
    UMLS CUI [2,2]
    C1514721 (Range)
    LOINC
    LP21074-7
    UMLS CUI [2,3]
    C1515021 (Subgroup)
    Qualifying Value
    Descripción

    QUALVAL

    Tipo de datos

    text

    Alias
    UMLS CUI [1, 1]
    C1514624 (Qualifying)
    UMLS CUI [1,1]
    C1522609 (Numerical value)
    Header Comment
    Descripción

    HEADCMT

    Tipo de datos

    text

    Alias
    UMLS CUI [1, 1]
    C0947611 (Comment)
    LOINC
    LP72293-1
    Investigator
    Descripción

    INV

    Tipo de datos

    text

    Alias
    UMLS CUI [1, 1]
    C0035173 (Research Personnel)
    SNOMED
    769038007
    LOINC
    LA23773-7
    Site
    Descripción

    SITE

    Tipo de datos

    text

    Alias
    UMLS CUI [1, 1]
    C0205145 (Site)
    SNOMED
    10546003
    LOINC
    MTHU014632
    Subevent
    Descripción

    SUBVISIT

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C2983704 (Subordinate)
    UMLS CUI [1,2]
    C0441471 (Event)
    SNOMED
    272379006
    LOINC
    LP94957-5
    Clinical Planned Event
    Descripción

    VISIT

    Tipo de datos

    text

    Alias
    UMLS CUI [1, 1]
    C0205210 (Clinical)
    SNOMED
    58147004
    UMLS CUI [1,1]
    C1301732 (Planned)
    SNOMED
    397943006
    LOINC
    LA20099-0
    UMLS CUI [1,2]
    C0441471 (Event)
    SNOMED
    272379006
    LOINC
    LP94957-5
    Blank Flag
    Descripción

    BLANK

    Tipo de datos

    text

    Alias
    UMLS CUI [1, 1]
    C1708067 (Flag)
    DCM Date
    Descripción

    DCMDATE

    Tipo de datos

    date

    Alias
    UMLS CUI [1, 1]
    C1302413 (Specimen collection date)
    SNOMED
    399445004
    Document Number
    Descripción

    DOCNUM

    Tipo de datos

    text

    Alias
    UMLS CUI [1, 1]
    C2986015 (Document Version Number Text)
    Patient
    Descripción

    PATIENT

    Tipo de datos

    text

    Alias
    UMLS CUI [1, 1]
    C0030705 (Patients)
    SNOMED
    116154003
    Planned time
    Descripción

    PTM

    Tipo de datos

    text

    Alias
    UMLS CUI [1, 1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    UMLS CUI [1, 2]
    C1301732 (Planned)
    SNOMED
    397943006
    LOINC
    LA20099-0
    Date of sample
    Descripción

    BLDDT

    Tipo de datos

    date

    Alias
    UMLS CUI [1, 1]
    C1302413 (Specimen collection date)
    SNOMED
    399445004
    Time of sample
    Descripción

    BLDATM

    Tipo de datos

    partialTime

    Alias
    UMLS CUI [1, 1]
    C4064021 (specimen collection time)
    Blood sample taken
    Descripción

    BLD

    Tipo de datos

    text

    Alias
    UMLS CUI [1, 1]
    C1277698 (Blood sample taken)
    SNOMED
    313334002
    Comment - english
    Descripción

    BLDX

    Tipo de datos

    text

    Alias
    UMLS CUI [1, 1]
    C0947611 (Comment)
    LOINC
    LP72293-1
    UMLS CUI [1,1]
    C0376245 (English Language)
    SNOMED
    297487008
    LOINC
    LA43-5
    Planned time numeric
    Descripción

    PTMN

    Tipo de datos

    float

    Alias
    UMLS CUI [1, 1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    UMLS CUI [1, 2]
    C1301732 (Planned)
    SNOMED
    397943006
    LOINC
    LA20099-0
    UMLS CUI [1, 3]
    C2825553 (Numeric Value)
    Hours first dose to sample begin
    Descripción

    SAMHBFD

    Tipo de datos

    float

    Alias
    UMLS CUI [1,1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    UMLS CUI [1,2]
    C0439568 (Post-dose)
    SNOMED
    255566006
    UMLS CUI [1,3]
    C0439227 (Hour)
    SNOMED
    258702006
    UMLS CUI [1,4]
    C0205435 (First (number))
    SNOMED
    255216001
    LOINC
    LP96880-7
    UMLS CUI [1,5]
    C3174092 (Medication dose)
    LOINC
    LP116765-1
    UMLS CUI [1,6]
    C0439659 (Beginning)
    SNOMED
    255395001
    LOINC
    LP21371-7
    UMLS CUI [1,7]
    C4064021 (specimen collection time)
    Hours last dose to sample begin
    Descripción

    SAMHBLD

    Tipo de datos

    float

    Alias
    UMLS CUI [1,1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    UMLS CUI [1,2]
    C0439568 (Post-dose)
    SNOMED
    255566006
    UMLS CUI [1,3]
    C0439227 (Hour)
    SNOMED
    258702006
    UMLS CUI [1,4]
    C1517741 (Last)
    LOINC
    LP200101-6
    UMLS CUI [1,5]
    C3174092 (Medication dose)
    LOINC
    LP116765-1
    UMLS CUI [1,6]
    C0439659 (Beginning)
    SNOMED
    255395001
    LOINC
    LP21371-7
    UMLS CUI [1,7]
    C4064021 (specimen collection time)
    Single regimen code used for PK
    Descripción

    BLDREG

    Tipo de datos

    text

    Alias
    UMLS CUI [1, 1]
    C1276413 (Therapeutic regimen)
    SNOMED
    133877004
    UMLS CUI [1,1]
    C0805701 (Code)
    UMLS CUI [1,2]
    C0031327 (Drug Kinetics)
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    Similar models

    Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD

    352 formularios
    1. StudyEvent: CUM_AE
      1. Description: Adverse Event | Help Text: (S)
      2. Description: Physical Examination ECOG score only | Help Text: (P)
      3. Description: Concomitant Therapies | Help Text: (S)
      4. Description: Areterial Blood Gases
      5. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    2. StudyEvent: CUM_CT
      1. Description: Concomitant Therapies | Help Text: (S)
      2. Description: Study Medication (BIBF)
      3. Description: Adverse Event | Help Text: (S)
      4. Description: Termination of Period/Trial Medication | Help Text: (S)
      5. Description: Administration of BIBF Before | Help Text: (P) PKADM
      6. Description: Medication Compliance
      7. Description: Patient Eligibility | Help Text: (S)
    3. StudyEvent: TRT CHANGE
      1. Description: Study Medication (BIBF)
    4. StudyEvent: IVRS
      1. Description: Information from IVRS
    5. StudyEvent: VISIT 1
      1. Description: Patient Demographics | Help Text: (S)
      2. Description: Physical Examination (Screening) | Help Text: (P)
      3. Description: Concomitant Diagnosis / Baseline Conditions | Help Text: (S)
      4. Description: Six minutes walking test
      5. Description: Lab samples taken | Help Text: (O)
      6. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
      7. Description: Pregnancy test | Help Text: (P)
      8. Description: ECG at screening | Help Text: (P)
      9. Description: Lab samples taken | Help Text: (O)
      10. Description: Lab Batch | Help Text: (O)
      11. Description: Pulmonary Function Testing | Help Text: (P)
      12. Description: Diagnosis of IPF
      13. Description: Inclusion/Exclusion Criteria | Help Text: (S)
      14. Description: Patient Eligibility | Help Text: (S)
      15. Description: Physical Examination ECOG score only | Help Text: (P)
      16. Description: Determination of DLco
      17. Description: Areterial Blood Gases
      18. Description: Concomitant Therapies | Help Text: (S)
      19. Description: Lab samples taken | Help Text: (O)
      20. Description: St. George's Respiratory Questionnaire | Help Text: (P)
      21. Description: Medical research council dyspnoea score
      22. Description: Physical Examination (except V3 V5) | Help Text: (P)
      23. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
      24. Description: Substance measurement at time point | Help Text: (P)
      25. Description: Pharmacokinetic parameter PD | Help Text: (P)
    6. StudyEvent: VISIT 2
      1. Description: Diagnosis of IPF
      2. Description: Physical Examination (except V3 V5) | Help Text: (P)
      3. Description: St. George's Respiratory Questionnaire | Help Text: (P)
      4. Description: Medical research council dyspnoea score
      5. Description: Lab samples taken | Help Text: (O)
      6. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
      7. Description: genetic informed conset
      8. Description: Pregnancy test | Help Text: (P)
      9. Description: Lab samples taken | Help Text: (O)
      10. Description: Pulmonary Function Testing | Help Text: (P)
      11. Description: Determination of DLco
      12. Description: Areterial Blood Gases
      13. Description: Six minutes walking test
      14. Description: Inclusion/Exclusion Criteria | Help Text: (S)
      15. Description: Patient Eligibility | Help Text: (S)
      16. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
      17. Description: Administration of BIBF now (not used) | Help Text: (P) PKADM
      18. Description: Lab Batch | Help Text: (O)
      19. Description: Pulmonary Function Testing | Help Text: (P)
      20. Description: Administration of BIBF now | Help Text: (P) PKADM
      21. Description: Concomitant Therapies | Help Text: (S)
      22. Description: Assigned Medication Number(s) from Label(s)
      23. Description: Assigned Medication Number(s) from Label(s)
      24. Description: Substance measurement at time point | Help Text: (P)
      25. Description: Pharmacokinetic parameter | Help Text: (P)
      26. Description: Pharmacokinetic parameter PD | Help Text: (P)
    7. StudyEvent: VISIT 3
      1. Description: Medication Compliance
      2. Description: Physical Examination ECOG score only | Help Text: (P)
      3. Description: ECG | Help Text: (P)
      4. Description: Lab samples taken | Help Text: (O)
      5. Description: Lab samples taken | Help Text: (O)
      6. Description: Pulmonary Function Testing | Help Text: (P)
      7. Description: Lab Batch | Help Text: (O)
      8. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
      9. Description: Substance measurement at time point | Help Text: (P)
    8. StudyEvent: VISIT 4
      1. Description: Medication Compliance
      2. Description: Administration of BIBF Before (not used) | Help Text: (P) PKADM
      3. Description: Physical Examination (except V3 V5) | Help Text: (P)
      4. Description: ECG | Help Text: (P)
      5. Description: Lab samples taken | Help Text: (O)
      6. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
      7. Description: Lab samples taken | Help Text: (O)
      8. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
      9. Description: Assigned Medication Number(s) from Label(s)
      10. Description: Lab Batch | Help Text: (O)
      11. Description: Administration of BIBF now (not used) | Help Text: (P) PKADM
      12. Description: Pulmonary Function Testing | Help Text: (P)
      13. Description: Administration of BIBF Before | Help Text: (P) PKADM
      14. Description: Administration of BIBF now | Help Text: (P) PKADM
      15. Description: genetic informed conset
      16. Description: Substance measurement at time point | Help Text: (P)
      17. Description: Pharmacokinetic parameter | Help Text: (P)
      18. Description: Pharmacokinetic parameter PD | Help Text: (P)
    9. StudyEvent: VISIT 5
      1. Description: Medication Compliance
      2. Description: Physical Examination ECOG score only | Help Text: (P)
      3. Description: Lab samples taken | Help Text: (O)
      4. Description: Lab samples taken | Help Text: (O)
      5. Description: Lab Batch | Help Text: (O)
      6. Description: Pulmonary Function Testing | Help Text: (P)
      7. Description: Administration of BIBF now | Help Text: (P) PKADM
      8. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
      9. Description: Administration of BIBF Before | Help Text: (P) PKADM
      10. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
      11. Description: Substance measurement at time point | Help Text: (P)
    10. StudyEvent: VISIT 6
      1. Description: Medication Compliance
      2. Description: Physical Examination (except V3 V5) | Help Text: (P)
      3. Description: St. George's Respiratory Questionnaire | Help Text: (P)
      4. Description: Medical research council dyspnoea score
      5. Description: ECG | Help Text: (P)
      6. Description: Lab samples taken | Help Text: (O)
      7. Description: Pregnancy test | Help Text: (P)
      8. Description: Lab samples taken | Help Text: (O)
      9. Description: Assigned Medication Number(s) from Label(s)
      10. Description: Lab Batch | Help Text: (O)
      11. Description: Pulmonary Function Testing | Help Text: (P)
      12. Description: Adverse Event | Help Text: (S)
      13. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
      14. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
      15. Description: Administration of BIBF now | Help Text: (P) PKADM
      16. Description: Substance measurement at time point | Help Text: (P)
    11. StudyEvent: VISIT 6A
      1. Description: Lab samples taken | Help Text: (O)
      2. Description: Lab Batch | Help Text: (O)
      3. Description: Six minutes walking test
      4. Description: Areterial Blood Gases
      5. Description: Pulmonary Function Testing | Help Text: (P)
      6. Description: Determination of DLco
      7. Description: Pulmonary Function Testing | Help Text: (P)
    12. StudyEvent: VISIT 7
      1. Description: Medication Compliance
      2. Description: Administration of BIBF Before | Help Text: (P) PKADM
      3. Description: Physical Examination (except V3 V5) | Help Text: (P)
      4. Description: St. George's Respiratory Questionnaire | Help Text: (P)
      5. Description: Medical research council dyspnoea score
      6. Description: ECG | Help Text: (P)
      7. Description: Lab samples taken | Help Text: (O)
      8. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
      9. Description: Pregnancy test | Help Text: (P)
      10. Description: Lab samples taken | Help Text: (O)
      11. Description: Pulmonary Function Testing | Help Text: (P)
      12. Description: Six minutes walking test
      13. Description: Determination of DLco
      14. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
      15. Description: Administration of BIBF now | Help Text: (P) PKADM
      16. Description: Assigned Medication Number(s) from Label(s)
      17. Description: Lab Batch | Help Text: (O)
      18. Description: Pulmonary Function Testing | Help Text: (P)
      19. Description: Areterial Blood Gases
      20. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
      21. Description: Substance measurement at time point | Help Text: (P)
      22. Description: Pharmacokinetic parameter | Help Text: (P)
      23. Description: Pharmacokinetic parameter PD | Help Text: (P)
    13. StudyEvent: VISIT 7A
      1. Description: Lab samples taken | Help Text: (O)
      2. Description: Lab Batch | Help Text: (O)
      3. Description: Six minutes walking test
      4. Description: Pulmonary Function Testing | Help Text: (P)
      5. Description: Determination of DLco
    14. StudyEvent: VISIT 8
      1. Description: Medication Compliance
      2. Description: Physical Examination (except V3 V5) | Help Text: (P)
      3. Description: ECG | Help Text: (P)
      4. Description: Lab samples taken | Help Text: (O)
      5. Description: Pregnancy test | Help Text: (P)
      6. Description: Lab samples taken | Help Text: (O)
      7. Description: Assigned Medication Number(s) from Label(s)
      8. Description: Lab Batch | Help Text: (O)
      9. Description: Pulmonary Function Testing | Help Text: (P)
      10. Description: Determination of DLco
      11. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
      12. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
      13. Description: Substance measurement at time point | Help Text: (P)
    15. StudyEvent: VISIT 8A
      1. Description: Lab Batch | Help Text: (O)
      2. Description: Lab samples taken | Help Text: (O)
      3. Description: Physical Examination ECOG score only | Help Text: (P)
      4. Description: Pulmonary Function Testing | Help Text: (P)
    16. StudyEvent: VISIT 9
      1. Description: Medication Compliance
      2. Description: Administration of BIBF Before | Help Text: (P) PKADM
      3. Description: Physical Examination (except V3 V5) | Help Text: (P)
      4. Description: St. George's Respiratory Questionnaire | Help Text: (P)
      5. Description: Medical research council dyspnoea score
      6. Description: Lab samples taken | Help Text: (O)
      7. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
      8. Description: Pregnancy test | Help Text: (P)
      9. Description: Lab samples taken | Help Text: (O)
      10. Description: Pulmonary Function Testing | Help Text: (P)
      11. Description: Six minutes walking test
      12. Description: Determination of DLco
      13. Description: Areterial Blood Gases
      14. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
      15. Description: Administration of BIBF now | Help Text: (P) PKADM
      16. Description: Lab Batch | Help Text: (O)
      17. Description: Pulmonary Function Testing | Help Text: (P)
      18. Description: ECG | Help Text: (P)
      19. Description: Substance measurement at time point | Help Text: (P)
      20. Description: Pharmacokinetic parameter | Help Text: (P)
      21. Description: Pharmacokinetic parameter PD | Help Text: (P)
    17. StudyEvent: END TRT 1
      1. Description: Termination of Period/Trial Medication | Help Text: (S)
      2. Description: Assigned Medication Number(s) from Label(s)
      3. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    18. StudyEvent: VISIT 10
      1. Description: Administration of BIBF Before | Help Text: (P) PKADM
      2. Description: Medication Compliance
      3. Description: Physical Examination (except V3 V5) | Help Text: (P)
      4. Description: ECG | Help Text: (P)
      5. Description: Lab samples taken | Help Text: (O)
      6. Description: Pregnancy test | Help Text: (P)
      7. Description: Lab samples taken | Help Text: (O)
      8. Description: Lab Batch | Help Text: (O)
      9. Description: Pulmonary Function Testing | Help Text: (P)
      10. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
      11. Description: Substance measurement at time point | Help Text: (P)
    19. StudyEvent: VISIT 11
      1. Description: Medication Compliance
      2. Description: Physical Examination (except V3 V5) | Help Text: (P)
      3. Description: ECG | Help Text: (P)
      4. Description: Lab samples taken | Help Text: (O)
      5. Description: Pregnancy test | Help Text: (P)
      6. Description: Lab samples taken | Help Text: (O)
      7. Description: Assigned Medication Number(s) from Label(s)
      8. Description: Pulmonary Function Testing | Help Text: (P)
      9. Description: Lab Batch | Help Text: (O)
      10. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
      11. Description: Substance measurement at time point | Help Text: (P)
    20. StudyEvent: VISIT 12
      1. Description: Medication Compliance
      2. Description: Physical Examination (except V3 V5) | Help Text: (P)
      3. Description: ECG | Help Text: (P)
      4. Description: Lab samples taken | Help Text: (O)
      5. Description: Pregnancy test | Help Text: (P)
      6. Description: Lab samples taken | Help Text: (O)
      7. Description: Assigned Medication Number(s) from Label(s)
      8. Description: Pulmonary Function Testing | Help Text: (P)
      9. Description: Lab Batch | Help Text: (O)
      10. Description: Pulmonary Function Testing | Help Text: (P)
      11. Description: Areterial Blood Gases
      12. Description: Determination of DLco
      13. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
      14. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
      15. Description: Substance measurement at time point | Help Text: (P)
    21. StudyEvent: VISIT 12A
      1. Description: Lab Batch | Help Text: (O)
      2. Description: Lab samples taken | Help Text: (O)
      3. Description: ECG | Help Text: (P)
      4. Description: Lab samples taken | Help Text: (O)
      5. Description: Pulmonary Function Testing | Help Text: (P)
    22. StudyEvent: VISIT 13
      1. Description: Medication Compliance
      2. Description: Physical Examination (except V3 V5) | Help Text: (P)
      3. Description: ECG | Help Text: (P)
      4. Description: Lab samples taken | Help Text: (O)
      5. Description: Pregnancy test | Help Text: (P)
      6. Description: Lab samples taken | Help Text: (O)
      7. Description: Determination of DLco
      8. Description: Assigned Medication Number(s) from Label(s)
      9. Description: Pulmonary Function Testing | Help Text: (P)
      10. Description: Lab Batch | Help Text: (O)
      11. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
      12. Description: Substance measurement at time point | Help Text: (P)
    23. StudyEvent: VISIT 13A
      1. Description: Lab samples taken | Help Text: (O)
      2. Description: Lab Batch | Help Text: (O)
      3. Description: ECG | Help Text: (P)
    24. StudyEvent: VISIT 13B
      1. Description: Lab samples taken | Help Text: (O)
      2. Description: Lab Batch | Help Text: (O)
    25. StudyEvent: VISIT 13C
      1. Description: Lab Batch | Help Text: (O)
      2. Description: Lab samples taken | Help Text: (O)
      3. Description: Concomitant Therapies | Help Text: (S)
      4. Description: Physical Examination ECOG score only | Help Text: (P)
    26. StudyEvent: VISIT 14
      1. Description: Medication Compliance
      2. Description: Physical Examination (except V3 V5) | Help Text: (P)
      3. Description: ECG | Help Text: (P)
      4. Description: Lab samples taken | Help Text: (O)
      5. Description: Pregnancy test | Help Text: (P)
      6. Description: Lab samples taken | Help Text: (O)
      7. Description: Determination of DLco
      8. Description: Assigned Medication Number(s) from Label(s)
      9. Description: Pulmonary Function Testing | Help Text: (P)
      10. Description: Lab Batch | Help Text: (O)
    27. StudyEvent: VISIT 14A
      1. Description: Lab samples taken | Help Text: (O)
      2. Description: Lab Batch | Help Text: (O)
    28. StudyEvent: VISIT 14B
      1. Description: Lab samples taken | Help Text: (O)
      2. Description: Lab Batch | Help Text: (O)
      3. Description: Pulmonary Function Testing | Help Text: (P)
    29. StudyEvent: VISIT 14C
      1. Description: Lab samples taken | Help Text: (O)
      2. Description: Lab Batch | Help Text: (O)
    30. StudyEvent: VISIT 15
      1. Description: Medication Compliance
      2. Description: Physical Examination (except V3 V5) | Help Text: (P)
      3. Description: ECG | Help Text: (P)
      4. Description: Lab samples taken | Help Text: (O)
      5. Description: Pregnancy test | Help Text: (P)
      6. Description: Lab samples taken | Help Text: (O)
      7. Description: Determination of DLco
      8. Description: Assigned Medication Number(s) from Label(s)
      9. Description: Lab Batch | Help Text: (O)
      10. Description: Pulmonary Function Testing | Help Text: (P)
    31. StudyEvent: VISIT 15A
      1. Description: Lab Batch | Help Text: (O)
      2. Description: Lab samples taken | Help Text: (O)
    32. StudyEvent: VISIT 15B
      1. Description: Lab samples taken | Help Text: (O)
      2. Description: Lab Batch | Help Text: (O)
    33. StudyEvent: VISIT 15C
      1. Description: Lab samples taken | Help Text: (O)
      2. Description: Lab Batch | Help Text: (O)
    34. StudyEvent: VISIT 16
      1. Description: Medication Compliance
      2. Description: Physical Examination (except V3 V5) | Help Text: (P)
      3. Description: ECG | Help Text: (P)
      4. Description: Lab samples taken | Help Text: (O)
      5. Description: Pregnancy test | Help Text: (P)
      6. Description: Lab samples taken | Help Text: (O)
      7. Description: Determination of DLco
      8. Description: Assigned Medication Number(s) from Label(s)
      9. Description: Pulmonary Function Testing | Help Text: (P)
      10. Description: Lab Batch | Help Text: (O)
    35. StudyEvent: VISIT 16A
      1. Description: Lab samples taken | Help Text: (O)
      2. Description: Lab Batch | Help Text: (O)
    36. StudyEvent: VISIT 16B
      1. Description: Lab samples taken | Help Text: (O)
      2. Description: Lab Batch | Help Text: (O)
    37. StudyEvent: VISIT 16C
      1. Description: Lab samples taken | Help Text: (O)
      2. Description: Lab Batch | Help Text: (O)
    38. StudyEvent: END TRT 2
      1. Description: Termination of Period/Trial Medication | Help Text: (S)
      2. Description: Patient Vital Status | Help Text: (O)
    39. StudyEvent: EOT
      1. Description: Medication Compliance
      2. Description: Physical Examination (except V3 V5) | Help Text: (P)
      3. Description: ECG | Help Text: (P)
      4. Description: Lab samples taken | Help Text: (O)
      5. Description: Pregnancy test | Help Text: (P)
      6. Description: Lab samples taken | Help Text: (O)
      7. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
      8. Description: Lab Batch | Help Text: (O)
      9. Description: Pulmonary Function Testing | Help Text: (P)
      10. Description: St. George's Respiratory Questionnaire | Help Text: (P)
      11. Description: Medical research council dyspnoea score
      12. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
      13. Description: Pulmonary Function Testing | Help Text: (P)
      14. Description: Six minutes walking test
      15. Description: Determination of DLco
      16. Description: Areterial Blood Gases
      17. Description: Substance measurement at time point | Help Text: (P)
    40. StudyEvent: FOLLOWUP
      1. Description: Physical Examination (except V3 V5) | Help Text: (P)
      2. Description: Patient Vital Status | Help Text: (O)
      3. Description: Lab samples taken | Help Text: (O)
    41. StudyEvent: DISC V4
      1. Description: Physical Examination ECOG score only | Help Text: (P)
      2. Description: Lab samples taken | Help Text: (O)
      3. Description: Pulmonary Function Testing | Help Text: (P)
    42. StudyEvent: DISC V5
      1. Description: Physical Examination ECOG score only | Help Text: (P)
      2. Description: Lab samples taken | Help Text: (O)
      3. Description: Pulmonary Function Testing | Help Text: (P)
    43. StudyEvent: DISC V6
      1. Description: Physical Examination ECOG score only | Help Text: (P)
      2. Description: Lab samples taken | Help Text: (O)
      3. Description: Pulmonary Function Testing | Help Text: (P)
    44. StudyEvent: DISC V7
      1. Description: Physical Examination ECOG score only | Help Text: (P)
      2. Description: Lab samples taken | Help Text: (O)
      3. Description: Pulmonary Function Testing | Help Text: (P)
    45. StudyEvent: DISC V8
      1. Description: Physical Examination ECOG score only | Help Text: (P)
      2. Description: Lab samples taken | Help Text: (O)
      3. Description: Pulmonary Function Testing | Help Text: (P)
      4. Description: Lab samples taken | Help Text: (O)
    46. StudyEvent: DISC V9
      1. Description: Physical Examination ECOG score only | Help Text: (P)
      2. Description: Lab samples taken | Help Text: (O)
      3. Description: Pulmonary Function Testing | Help Text: (P)
      4. Description: Pulmonary Function Testing | Help Text: (P)
    47. StudyEvent: COMPLETION
      1. Description: Trial Completion | Help Text: (O)
      2. Description: Patient Vital Status | Help Text: (O)
      3. Description: Physical Examination ECOG score only | Help Text: (P)
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    C0005834 (UMLS CUI [1,1])
    LOCKED
    Item
    Locked
    text
    C3244297 (UMLS CUI [1, 1])
    LAB
    Item
    Lab and lab range subset
    text
    C0022877 (UMLS CUI [1,1])
    C0022877 (UMLS CUI [2,1])
    C1514721 (UMLS CUI [2,2])
    C1515021 (UMLS CUI [2,3])
    QUALVAL
    Item
    Qualifying Value
    text
    C1514624 (UMLS CUI [1, 1])
    C1522609 (UMLS CUI [1,1])
    HEADCMT
    Item
    Header Comment
    text
    C0947611 (UMLS CUI [1, 1])
    INV
    Item
    Investigator
    text
    C0035173 (UMLS CUI [1, 1])
    SITE
    Item
    Site
    text
    C0205145 (UMLS CUI [1, 1])
    SUBVISIT
    Item
    Subevent
    text
    C2983704 (UMLS CUI [1,1])
    C0441471 (UMLS CUI [1,2])
    VISIT
    Item
    Clinical Planned Event
    text
    C0205210 (UMLS CUI [1, 1])
    C1301732 (UMLS CUI [1,1])
    C0441471 (UMLS CUI [1,2])
    BLANK
    Item
    Blank Flag
    text
    C1708067 (UMLS CUI [1, 1])
    DCMDATE
    Item
    DCM Date
    date
    C1302413 (UMLS CUI [1, 1])
    DOCNUM
    Item
    Document Number
    text
    C2986015 (UMLS CUI [1, 1])
    PATIENT
    Item
    Patient
    text
    C0030705 (UMLS CUI [1, 1])
    PTM
    Item
    Planned time
    text
    C0040223 (UMLS CUI [1, 1])
    C1301732 (UMLS CUI [1, 2])
    BLDDT
    Item
    Date of sample
    date
    C1302413 (UMLS CUI [1, 1])
    BLDATM
    Item
    Time of sample
    partialTime
    C4064021 (UMLS CUI [1, 1])
    Item
    Blood sample taken
    text
    C1277698 (UMLS CUI [1, 1])
    YNF-1
    Code List
    Blood sample taken
    CL Item
    No (0)
    C1298908 (UMLS CUI [1,1])
    CL Item
    Yes (1)
    C1705108 (UMLS CUI [1,1])
    BLDX
    Item
    Comment - english
    text
    C0947611 (UMLS CUI [1, 1])
    C0376245 (UMLS CUI [1,1])
    PTMN
    Item
    Planned time numeric
    float
    C0040223 (UMLS CUI [1, 1])
    C1301732 (UMLS CUI [1, 2])
    C2825553 (UMLS CUI [1, 3])
    SAMHBFD
    Item
    Hours first dose to sample begin
    float
    C0040223 (UMLS CUI [1,1])
    C0439568 (UMLS CUI [1,2])
    C0439227 (UMLS CUI [1,3])
    C0205435 (UMLS CUI [1,4])
    C3174092 (UMLS CUI [1,5])
    C0439659 (UMLS CUI [1,6])
    C4064021 (UMLS CUI [1,7])
    SAMHBLD
    Item
    Hours last dose to sample begin
    float
    C0040223 (UMLS CUI [1,1])
    C0439568 (UMLS CUI [1,2])
    C0439227 (UMLS CUI [1,3])
    C1517741 (UMLS CUI [1,4])
    C3174092 (UMLS CUI [1,5])
    C0439659 (UMLS CUI [1,6])
    C4064021 (UMLS CUI [1,7])
    BLDREG
    Item
    Single regimen code used for PK
    text
    C1276413 (UMLS CUI [1, 1])
    C0805701 (UMLS CUI [1,1])
    C0031327 (UMLS CUI [1,2])
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