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ID

45974

Description

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

Lien

NCT00514683

Mots-clés

Versions (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
Détendeur de droits

Boehringer Ingelheim

Téléchargé le

28 marzo 2024

DOI

Pour une demande vous connecter.

Licence

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

    Anglais

    Description: Adverse Event | Help Text: (S)

    352 Formulaires  
    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)
    AED
    Description

    AED

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0678257
    Locked
    Description

    LOCKED

    Type de données

    text

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

    LAB

    Type de données

    text

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

    QUALVAL

    Type de données

    text

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

    HEADCMT

    Type de données

    text

    Alias
    UMLS CUI [1, 1]
    C0947611
    Investigator
    Description

    INV

    Type de données

    text

    Alias
    UMLS CUI [1, 1]
    C0035173
    Site
    Description

    SITE

    Type de données

    text

    Alias
    UMLS CUI [1, 1]
    C0205145
    Subevent
    Description

    SUBVISIT

    Type de données

    text

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

    VISIT

    Type de données

    text

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

    BLANK

    Type de données

    text

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

    DCMDATE

    Type de données

    date

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

    DOCNUM

    Type de données

    text

    Alias
    UMLS CUI [1, 1]
    C2986015
    Patient
    Description

    PATIENT

    Type de données

    text

    Alias
    UMLS CUI [1, 1]
    C0030705
    Did the patient have any Adverse Events?
    Description

    AEI

    Type de données

    text

    Alias
    UMLS CUI [1, 1]
    C0030705
    UMLS CUI [1,1]
    C0877248
    Event
    Description

    AEMNM

    Type de données

    text

    Alias
    UMLS CUI [1, 1]
    C0441471
    Start date
    Description

    AEONYMD

    Type de données

    date

    Alias
    UMLS CUI [1, 1]
    C0808070
    UMLS CUI [1,1]
    C0877248
    AE ongoing? C=cont
    Description

    AEENDC

    Type de données

    text

    Alias
    UMLS CUI [1, 1]
    C0877248
    UMLS CUI [1,1]
    C0549178
    End date
    Description

    AEENDYMD

    Type de données

    date

    Alias
    UMLS CUI [1, 1]
    C0806020
    UMLS CUI [1,1]
    C0877248
    Intensity
    Description

    AEINT

    Type de données

    text

    Alias
    UMLS CUI [1, 1]
    C1710066
    Therapy
    Description

    AETHPA

    Type de données

    text

    Alias
    UMLS CUI [1, 1]
    C0087111
    UMLS CUI [1,1]
    C0877248
    Outcome
    Description

    AEOUT

    Type de données

    text

    Alias
    UMLS CUI [1, 1]
    C1705586
    Serious
    Description

    AESERA

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    Seriousness reason 1
    Description

    AESTC1

    Type de données

    text

    Alias
    UMLS CUI [1, 1]
    C1519255
    UMLS CUI [1,1]
    C1314792
    Seriousness reason 2
    Description

    AESTC2

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C1314792
    Seriousness reason 3
    Description

    AESTC3

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C1314792
    Seriousness reason 4
    Description

    AESTC4

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C1314792
    Causal relationship (investigator)
    Description

    AEREL

    Type de données

    text

    Alias
    UMLS CUI [1, 1]
    C0035173
    UMLS CUI [1,1]
    C1314792
    Exacerbation of TD
    Description

    AEEXATD

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C4086268
    AEs at end of trial F-up satisfactory
    Description

    AEFUP

    Type de données

    text

    Alias
    UMLS CUI [1, 1]
    C0008976
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C1522577
    UMLS CUI [1,3]
    C0205410
    Entry date
    Description

    ENTRYDT1

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C1978797
    Entry date
    Description

    ENTRYDT2

    Type de données

    date

    Alias
    UMLS CUI [1, 1]
    C1978797
    Comment
    Description

    AEX

    Type de données

    text

    Alias
    UMLS CUI [1, 1]
    C0947611
    AEONDT
    Description

    AEONDT

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C2985916
    AE onset date imputed
    Description

    AEONIMP

    Type de données

    integer

    Alias
    UMLS CUI [1, 1]
    C2985916
    UMLS CUI [1,1]
    C2699638
    AEENDDT
    Description

    AEENDDT

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C2697886
    AE end date imputed
    Description

    AEENDIMP

    Type de données

    integer

    Alias
    UMLS CUI [1, 1]
    C2697886
    UMLS CUI [1,1]
    C2699638
    AE end date censored
    Description

    AEENDCEN

    Type de données

    integer

    Alias
    UMLS CUI [1, 1]
    C2697886
    AEONSETU
    Description

    AEONSETU

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0332162
    AEQ
    Description

    AEQ

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    AE clinical monitor significant
    Description

    AECMSIG

    Type de données

    integer

    Alias
    UMLS CUI [1, 1]
    C1521743
    UMLS CUI [1,1]
    C0877248
    AELLT
    Description

    AELLT

    Type de données

    text

    Alias
    UMLS CUI [1, 1]
    C3900085
    AELLTCD
    Description

    AELLTCD

    Type de données

    text

    Alias
    UMLS CUI [1, 1]
    C3897027
    Action
    Description

    AEACTA

    Type de données

    text

    Alias
    UMLS CUI [1, 1]
    C0441472
    AEOX
    Description

    AEOX

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    AE other significant
    Description

    AEOTHSIG

    Type de données

    integer

    Alias
    UMLS CUI [1, 1]
    C0205394
    UMLS CUI [1,1]
    C0750502
    UMLS CUI [1,2]
    C0877248
    Retour au début de la page

    Similar models

    Description: Adverse Event | Help Text: (S)

    352 Formulaires
    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
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    C0877248 (UMLS CUI [1,1])
    C0678257 (UMLS CUI [1,2])
    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])
    C0441471 (UMLS CUI [1,1])
    C1301732 (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
    Did the patient have any Adverse Events?
    text
    C0030705 (UMLS CUI [1, 1])
    C0877248 (UMLS CUI [1,1])
    YNF-1
    Code List
    Did the patient have any Adverse Events?
    CL Item
    No (0)
    C1298908 (UMLS CUI [1,1])
    CL Item
    Yes (1)
    C1705108 (UMLS CUI [1,1])
    AEMNM
    Item
    Event
    text
    C0441471 (UMLS CUI [1, 1])
    AEONYMD
    Item
    Start date
    date
    C0808070 (UMLS CUI [1, 1])
    C0877248 (UMLS CUI [1,1])
    Item
    AE ongoing? C=cont
    text
    C0877248 (UMLS CUI [1, 1])
    C0549178 (UMLS CUI [1,1])
    CONTF-1
    Code List
    AE ongoing? C=cont
    CL Item
    Cont. (C)
    C0439598 (UMLS CUI [1,1])
    AEENDYMD
    Item
    End date
    date
    C0806020 (UMLS CUI [1, 1])
    C0877248 (UMLS CUI [1,1])
    Item
    Intensity
    text
    C1710066 (UMLS CUI [1, 1])
    AEINTF-1
    Code List
    Intensity
    CL Item
    Mild (1)
    C1513302 (UMLS CUI [1,1])
    CL Item
    Moderate (2)
    C1513374 (UMLS CUI [1,1])
    CL Item
    Severe (3)
    C1519275 (UMLS CUI [1,1])
    Item
    Therapy
    text
    C0087111 (UMLS CUI [1, 1])
    C0877248 (UMLS CUI [1,1])
    YNF-1
    Code List
    Therapy
    CL Item
    No (0)
    C1298908 (UMLS CUI [1,1])
    CL Item
    Yes (1)
    C1705108 (UMLS CUI [1,1])
    Item
    Outcome
    text
    C1705586 (UMLS CUI [1, 1])
    AEOUTF-1
    Code List
    Outcome
    CL Item
    Recovered (1)
    C1709863 (UMLS CUI [1,1])
    CL Item
    Not yet recov. (2)
    C1709277 (UMLS CUI [1,1])
    CL Item
    Sequelae (3)
    C1709862 (UMLS CUI [1,1])
    CL Item
    Fatal (4)
    C1302234 (UMLS CUI [1,1])
    CL Item
    Unknown (5)
    C0439673 (UMLS CUI [1,1])
    Item
    Serious
    text
    C1519255 (UMLS CUI [1,1])
    YNSF-1
    Code List
    Serious
    CL Item
    No (0)
    C1298908 (UMLS CUI [1,1])
    CL Item
    Yes (1)
    C1705108 (UMLS CUI [1,1])
    CL Item
    No, but significant (3)
    C1298908 (UMLS CUI [1,1])
    C0750502 (UMLS CUI [1,2])
    Item
    Seriousness reason 1
    text
    C1519255 (UMLS CUI [1, 1])
    C1314792 (UMLS CUI [1,1])
    AESTCF-1
    Code List
    Seriousness reason 1
    CL Item
    Fatal (1)
    CL Item
    Imm life-threatening (2)
    CL Item
    Disability/incap. (3)
    CL Item
    Req.hospitalisation (4)
    CL Item
    Prol.hospitalisation (5)
    CL Item
    Congenital anomaly (6)
    CL Item
    Other (7)
    Item
    Seriousness reason 2
    text
    C1519255 (UMLS CUI [1,1])
    C1314792 (UMLS CUI [1,2])
    AESTCF-1
    Code List
    Seriousness reason 2
    CL Item
    Fatal (1)
    CL Item
    Imm life-threatening (2)
    CL Item
    Disability/incap. (3)
    CL Item
    Req.hospitalisation (4)
    CL Item
    Prol.hospitalisation (5)
    CL Item
    Congenital anomaly (6)
    CL Item
    Other (7)
    Item
    Seriousness reason 3
    text
    C1519255 (UMLS CUI [1,1])
    C1314792 (UMLS CUI [1,2])
    AESTCF-1
    Code List
    Seriousness reason 3
    CL Item
    Fatal (1)
    CL Item
    Imm life-threatening (2)
    CL Item
    Disability/incap. (3)
    CL Item
    Req.hospitalisation (4)
    CL Item
    Prol.hospitalisation (5)
    CL Item
    Congenital anomaly (6)
    CL Item
    Other (7)
    Item
    Seriousness reason 4
    text
    C1519255 (UMLS CUI [1,1])
    C1314792 (UMLS CUI [1,2])
    AESTCF-1
    Code List
    Seriousness reason 4
    CL Item
    Fatal (1)
    CL Item
    Imm life-threatening (2)
    CL Item
    Disability/incap. (3)
    CL Item
    Req.hospitalisation (4)
    CL Item
    Prol.hospitalisation (5)
    CL Item
    Congenital anomaly (6)
    CL Item
    Other (7)
    Item
    Causal relationship (investigator)
    text
    C0035173 (UMLS CUI [1, 1])
    C1314792 (UMLS CUI [1,1])
    YNF-1
    Code List
    Causal relationship (investigator)
    CL Item
    No (0)
    C1298908 (UMLS CUI [1,1])
    CL Item
    Yes (1)
    C1705108 (UMLS CUI [1,1])
    Item
    Exacerbation of TD
    text
    C4086268 (UMLS CUI [1,1])
    YNF-1
    Code List
    Exacerbation of TD
    CL Item
    No (0)
    C1298908 (UMLS CUI [1,1])
    CL Item
    Yes (1)
    C1705108 (UMLS CUI [1,1])
    Item
    AEs at end of trial F-up satisfactory
    text
    C0008976 (UMLS CUI [1, 1])
    C0877248 (UMLS CUI [1,1])
    C1522577 (UMLS CUI [1,2])
    C0205410 (UMLS CUI [1,3])
    AEFUPF-1
    Code List
    AEs at end of trial F-up satisfactory
    CL Item
    Lost to follow-up (1)
    CL Item
    Follow-up sufficient (2)
    ENTRYDT1
    Item
    Entry date
    date
    C1978797 (UMLS CUI [1,1])
    ENTRYDT2
    Item
    Entry date
    date
    C1978797 (UMLS CUI [1, 1])
    AEX
    Item
    Comment
    text
    C0947611 (UMLS CUI [1, 1])
    AEONDT
    Item
    date
    C2985916 (UMLS CUI [1,1])
    AEONIMP
    Item
    AE onset date imputed
    integer
    C2985916 (UMLS CUI [1, 1])
    C2699638 (UMLS CUI [1,1])
    AEENDDT
    Item
    date
    C2697886 (UMLS CUI [1,1])
    AEENDIMP
    Item
    AE end date imputed
    integer
    C2697886 (UMLS CUI [1, 1])
    C2699638 (UMLS CUI [1,1])
    AEENDCEN
    Item
    AE end date censored
    integer
    C2697886 (UMLS CUI [1, 1])
    Item
    text
    C0877248 (UMLS CUI [1,1])
    C0332162 (UMLS CUI [1,2])
    UNITF-2
    Code List
    AEONSETU
    CL Item
    years (1)
    CL Item
    months (2)
    CL Item
    weeks (3)
    CL Item
    days (4)
    CL Item
    hr (5)
    CL Item
    min (6)
    CL Item
    seconds (7)
    CL Item
    msec (8)
    CL Item
    ksec (9)
    CL Item
    usec (10)
    CL Item
    csec (15)
    CL Item
    msec^2 (16)
    CL Item
    s*h (17)
    CL Item
    ms (19)
    Item
    text
    C0877248 (UMLS CUI [1,1])
    PGQF-1
    Code List
    AEQ
    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])
    AECMSIG
    Item
    AE clinical monitor significant
    integer
    C1521743 (UMLS CUI [1, 1])
    C0877248 (UMLS CUI [1,1])
    AELLT
    Item
    AELLT
    text
    C3900085 (UMLS CUI [1, 1])
    AELLTCD
    Item
    AELLTCD
    text
    C3897027 (UMLS CUI [1, 1])
    Item
    Action
    text
    C0441472 (UMLS CUI [1, 1])
    AEACTAF-1
    Code List
    Action
    CL Item
    Continued (1)
    CL Item
    Reduced (2)
    CL Item
    Discontinued (3)
    CL Item
    Increased (4)
    CL Item
    Compl. acc. protocol (5)
    CL Item
    Disc. and reintr. (6)
    CL Item
    NA (7)
    AEOX
    Item
    text
    C0877248 (UMLS CUI [1,1])
    AEOTHSIG
    Item
    AE other significant
    integer
    C0205394 (UMLS CUI [1, 1])
    C0750502 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
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