ID

45974

Beskrivning

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

Länk

NCT00514683

Nyckelord

Versioner (3)
  1. 2024-03-05 2024-03-05 - Dr. Christian Niklas
  2. 2024-03-28 2024-03-28 - Dr. Christian Niklas
  3. 2024-03-28 2024-03-28 - Dr. Christian Niklas
Rättsinnehavare

Boehringer Ingelheim

Uppladdad den

28 mars 2024

DOI

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Licens

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

Engelsk

Description: Adverse Event | Help Text: (S)

352 Formulär  
  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
Beskrivning

AED

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

LOCKED

Datatyp

text

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

LAB

Datatyp

text

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

QUALVAL

Datatyp

text

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

HEADCMT

Datatyp

text

Alias
UMLS CUI [1, 1]
C0947611
Investigator
Beskrivning

INV

Datatyp

text

Alias
UMLS CUI [1, 1]
C0035173
Site
Beskrivning

SITE

Datatyp

text

Alias
UMLS CUI [1, 1]
C0205145
Subevent
Beskrivning

SUBVISIT

Datatyp

text

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

VISIT

Datatyp

text

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

BLANK

Datatyp

text

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

DCMDATE

Datatyp

date

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

DOCNUM

Datatyp

text

Alias
UMLS CUI [1, 1]
C2986015
Patient
Beskrivning

PATIENT

Datatyp

text

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

AEI

Datatyp

text

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

AEMNM

Datatyp

text

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

AEONYMD

Datatyp

date

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

AEENDC

Datatyp

text

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

AEENDYMD

Datatyp

date

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

AEINT

Datatyp

text

Alias
UMLS CUI [1, 1]
C1710066
Therapy
Beskrivning

AETHPA

Datatyp

text

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

AEOUT

Datatyp

text

Alias
UMLS CUI [1, 1]
C1705586
Serious
Beskrivning

AESERA

Datatyp

text

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

AESTC1

Datatyp

text

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

AESTC2

Datatyp

text

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

AESTC3

Datatyp

text

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

AESTC4

Datatyp

text

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

AEREL

Datatyp

text

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

AEEXATD

Datatyp

text

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

AEFUP

Datatyp

text

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

ENTRYDT1

Datatyp

date

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

ENTRYDT2

Datatyp

date

Alias
UMLS CUI [1, 1]
C1978797
Comment
Beskrivning

AEX

Datatyp

text

Alias
UMLS CUI [1, 1]
C0947611
AEONDT
Beskrivning

AEONDT

Datatyp

date

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

AEONIMP

Datatyp

integer

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

AEENDDT

Datatyp

date

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

AEENDIMP

Datatyp

integer

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

AEENDCEN

Datatyp

integer

Alias
UMLS CUI [1, 1]
C2697886
AEONSETU
Beskrivning

AEONSETU

Datatyp

text

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

AEQ

Datatyp

text

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

AECMSIG

Datatyp

integer

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

AELLT

Datatyp

text

Alias
UMLS CUI [1, 1]
C3900085
AELLTCD
Beskrivning

AELLTCD

Datatyp

text

Alias
UMLS CUI [1, 1]
C3897027
Action
Beskrivning

AEACTA

Datatyp

text

Alias
UMLS CUI [1, 1]
C0441472
AEOX
Beskrivning

AEOX

Datatyp

text

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

AEOTHSIG

Datatyp

integer

Alias
UMLS CUI [1, 1]
C0205394
UMLS CUI [1,1]
C0750502
UMLS CUI [1,2]
C0877248
Tillbaka till toppen

Similar models

Description: Adverse Event | Help Text: (S)

352 Formulär
  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
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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