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ID

45974

Descrição

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

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Versões (3)
  1. 05/03/24 05/03/24 - Dr. Christian Niklas
  2. 28/03/24 28/03/24 - Dr. Christian Niklas
  3. 28/03/24 28/03/24 - Dr. Christian Niklas
Titular dos direitos

Boehringer Ingelheim

Transferido a

28 marzo 2024

DOI

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Licença

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

    Inglês

    Description: Study Medication (BIBF)

    352 Formulários  
    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)
    CTB
    Descrição

    CTB

    Locked
    Descrição

    LOCKED

    Tipo de dados

    text

    Alias
    UMLS CUI [1, 1]
    C3244297
    Lab and lab range subset
    Descrição

    LAB

    Tipo de dados

    text

    Alias
    UMLS CUI [1, 1]
    C0022877
    UMLS CUI [2,1]
    C0022877
    UMLS CUI [2,2]
    C1514721
    UMLS CUI [2,3]
    C1515021
    Qualifying Value
    Descrição

    QUALVAL

    Tipo de dados

    text

    Alias
    UMLS CUI [1, 1]
    C1514624
    UMLS CUI [1,1]
    C1522609
    Header Comment
    Descrição

    HEADCMT

    Tipo de dados

    text

    Alias
    UMLS CUI [1, 1]
    C0947611
    Investigator
    Descrição

    INV

    Tipo de dados

    text

    Alias
    UMLS CUI [1, 1]
    C0035173
    Site
    Descrição

    SITE

    Tipo de dados

    text

    Alias
    UMLS CUI [1, 1]
    C0205145
    Subevent
    Descrição

    SUBVISIT

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C2983704
    UMLS CUI [1,2]
    C0441471
    Clinical Planned Event
    Descrição

    VISIT

    Tipo de dados

    text

    Alias
    UMLS CUI [1, 1]
    C0205210
    UMLS CUI [1,1]
    C1301732
    UMLS CUI [1,2]
    C0441471
    Blank Flag
    Descrição

    BLANK

    Tipo de dados

    text

    Alias
    UMLS CUI [1, 1]
    C1708067
    DCM Date
    Descrição

    DCMDATE

    Tipo de dados

    date

    Alias
    UMLS CUI [1, 1]
    C1302413
    Document Number
    Descrição

    DOCNUM

    Tipo de dados

    text

    Alias
    UMLS CUI [1, 1]
    C2986015
    Patient
    Descrição

    PATIENT

    Tipo de dados

    text

    Alias
    UMLS CUI [1, 1]
    C0030705
    Any dose change or reduction?
    Descrição

    CTI

    Tipo de dados

    text

    Alias
    UMLS CUI [1, 1]
    C0392747
    UMLS CUI [1,1]
    C0392756
    UMLS CUI [1,2]
    C1707479
    Dose change / interruption
    Descrição

    ADMDSC

    Tipo de dados

    text

    Alias
    UMLS CUI [1, 1]
    C3174092
    UMLS CUI [1,1]
    C0392747
    UMLS CUI [1,2]
    C1512900
    Start Date
    Descrição

    CTBEGYMD

    Tipo de dados

    partialDate

    Alias
    UMLS CUI [1, 1]
    C0808070
    UMLS CUI [1,1]
    C1707479
    Day time start
    Descrição

    DAYTMA1

    Tipo de dados

    text

    Alias
    UMLS CUI [1, 1]
    C0439659
    UMLS CUI [1,1]
    C0332169
    End Date
    Descrição

    CTENDYMD

    Tipo de dados

    partialDate

    Alias
    UMLS CUI [1, 1]
    C0806020
    Day time end
    Descrição

    DAYTMA2

    Tipo de dados

    text

    Alias
    UMLS CUI [1, 1]
    C0806020
    UMLS CUI [1,1]
    C0332169
    Reason for dose change / interruption
    Descrição

    DOSREDC

    Tipo de dados

    text

    Alias
    UMLS CUI [1, 1]
    C0392360
    UMLS CUI [1,1]
    C0392747
    UMLS CUI [1,2]
    C3174092
    Indication - English
    Descrição

    CTINDX

    Tipo de dados

    text

    Alias
    UMLS CUI [1, 1]
    C0392360
    UMLS CUI [1,1]
    C0376245
    CTBEGDT
    Descrição

    CTBEGDT

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C2826734
    CTENDDT
    Descrição

    CTENDDT

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C2826744
    Actual Treatment Code
    Descrição

    ATRCD1

    Tipo de dados

    text

    Alias
    UMLS CUI [1, 1]
    C0087111
    UMLS CUI [1,1]
    C0805701
    UMLS CUI [1,2]
    C0237400
    Actual Treatment Start Date
    Descrição

    ATRSTDT1

    Tipo de dados

    date

    Alias
    UMLS CUI [1, 1]
    C0808070
    UMLS CUI [1,1]
    C0237400
    UMLS CUI [1,2]
    C0087111
    Actual Treatment Start Time
    Descrição

    ATRSTTM1

    Tipo de dados

    partialTime

    Alias
    UMLS CUI [1, 1]
    C0087111
    UMLS CUI [1,1]
    C1301880
    UMLS CUI [1,2]
    C0237400
    Actual Treatment Code
    Descrição

    ATRCD2

    Tipo de dados

    text

    Alias
    UMLS CUI [1, 1]
    C0087111
    UMLS CUI [1,1]
    C0805701
    UMLS CUI [1,2]
    C0237400
    Actual Treatment Start Date
    Descrição

    ATRSTDT2

    Tipo de dados

    date

    Alias
    UMLS CUI [1, 1]
    C0808070
    UMLS CUI [1,1]
    C0237400
    UMLS CUI [1,2]
    C0087111
    Actual Treatment Start Time
    Descrição

    ATRSTTM2

    Tipo de dados

    partialTime

    Alias
    UMLS CUI [1, 1]
    C0087111
    UMLS CUI [1,1]
    C1301880
    UMLS CUI [1,2]
    C0237400
    CTLLT
    Descrição

    CTLLT

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C3846158
    CTLLTCD
    Descrição

    CTLLTCD

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C3846158
    CTQ
    Descrição

    CTQ

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C2826666
    Therapy - English
    Descrição

    CTVNM

    Tipo de dados

    text

    Alias
    UMLS CUI [1, 1]
    C0087111
    UMLS CUI [1,1]
    C0376245
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    Similar models

    Description: Study Medication (BIBF)

    352 Formulários
    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 dados
    Alias
    Item Group
    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])
    Item
    Any dose change or reduction?
    text
    C0392747 (UMLS CUI [1, 1])
    C0392756 (UMLS CUI [1,1])
    C1707479 (UMLS CUI [1,2])
    YNF-1
    Code List
    Any dose change or reduction?
    CL Item
    No (0)
    C1298908 (UMLS CUI [1,1])
    CL Item
    Yes (1)
    C1705108 (UMLS CUI [1,1])
    Item
    Dose change / interruption
    text
    C3174092 (UMLS CUI [1, 1])
    C0392747 (UMLS CUI [1,1])
    C1512900 (UMLS CUI [1,2])
    ADMDSBF-1
    Code List
    Dose change / interruption
    CL Item
    Reduction (1)
    CL Item
    Interruption (2)
    CTBEGYMD
    Item
    Start Date
    partialDate
    C0808070 (UMLS CUI [1, 1])
    C1707479 (UMLS CUI [1,1])
    Item
    Day time start
    text
    C0439659 (UMLS CUI [1, 1])
    C0332169 (UMLS CUI [1,1])
    DAYTMF-2
    Code List
    Day time start
    CL Item
    Morning (1)
    C0332170 (UMLS CUI [1,1])
    CL Item
    Evening (2)
    C0587117 (UMLS CUI [1,1])
    CL Item
    Unknown (3)
    C0439673 (UMLS CUI [1,1])
    CTENDYMD
    Item
    End Date
    partialDate
    C0806020 (UMLS CUI [1, 1])
    Item
    Day time end
    text
    C0806020 (UMLS CUI [1, 1])
    C0332169 (UMLS CUI [1,1])
    DAYTMF-2
    Code List
    Day time end
    CL Item
    Morning (1)
    C0332170 (UMLS CUI [1,1])
    CL Item
    Evening (2)
    C0587117 (UMLS CUI [1,1])
    CL Item
    Unknown (3)
    C0439673 (UMLS CUI [1,1])
    Item
    Reason for dose change / interruption
    text
    C0392360 (UMLS CUI [1, 1])
    C0392747 (UMLS CUI [1,1])
    C3174092 (UMLS CUI [1,2])
    DOSRDCF-1
    Code List
    Reason for dose change / interruption
    CL Item
    Drug related AE (1)
    CL Item
    Other (2)
    CTINDX
    Item
    Indication - English
    text
    C0392360 (UMLS CUI [1, 1])
    C0376245 (UMLS CUI [1,1])
    CTBEGDT
    Item
    date
    C2826734 (UMLS CUI [1,1])
    CTENDDT
    Item
    date
    C2826744 (UMLS CUI [1,1])
    ATRCD1
    Item
    Actual Treatment Code
    text
    C0087111 (UMLS CUI [1, 1])
    C0805701 (UMLS CUI [1,1])
    C0237400 (UMLS CUI [1,2])
    ATRSTDT1
    Item
    Actual Treatment Start Date
    date
    C0808070 (UMLS CUI [1, 1])
    C0237400 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    ATRSTTM1
    Item
    Actual Treatment Start Time
    partialTime
    C0087111 (UMLS CUI [1, 1])
    C1301880 (UMLS CUI [1,1])
    C0237400 (UMLS CUI [1,2])
    ATRCD2
    Item
    Actual Treatment Code
    text
    C0087111 (UMLS CUI [1, 1])
    C0805701 (UMLS CUI [1,1])
    C0237400 (UMLS CUI [1,2])
    ATRSTDT2
    Item
    Actual Treatment Start Date
    date
    C0808070 (UMLS CUI [1, 1])
    C0237400 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    ATRSTTM2
    Item
    Actual Treatment Start Time
    partialTime
    C0087111 (UMLS CUI [1, 1])
    C1301880 (UMLS CUI [1,1])
    C0237400 (UMLS CUI [1,2])
    CTLLT
    Item
    CTLLT
    text
    C3846158 (UMLS CUI [1,1])
    CTLLTCD
    Item
    CTLLTCD
    text
    C3846158 (UMLS CUI [1,1])
    Item
    text
    C2826666 (UMLS CUI [1,1])
    PGQF-1
    Code List
    CTQ
    CL Item
    Cumulative D/T (1)
    C2986497 (UMLS CUI [1,1])
    CL Item
    Cumulative D (2)
    C2986497 (UMLS CUI [1,1])
    CL Item
    Period by period D/T (3)
    C2985822 (UMLS CUI [1,1])
    CL Item
    Period by period D (4)
    C2985822 (UMLS CUI [1,1])
    CTVNM
    Item
    Therapy - English
    text
    C0087111 (UMLS CUI [1, 1])
    C0376245 (UMLS CUI [1,1])
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