Engels

Description: St. George's Respiratory Questionnaire | Help Text: (P)

352 Formulieren  
  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)
SG
Beschrijving

SG

Alias
UMLS CUI [1,1]
C0451500
Locked
Beschrijving

LOCKED

Datatype

text

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

LAB

Datatype

text

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

QUALVAL

Datatype

text

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

HEADCMT

Datatype

text

Alias
UMLS CUI [1, 1]
C0947611
Investigator
Beschrijving

INV

Datatype

text

Alias
UMLS CUI [1, 1]
C0035173
Site
Beschrijving

SITE

Datatype

text

Alias
UMLS CUI [1, 1]
C0205145
Subevent
Beschrijving

SUBVISIT

Datatype

text

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

VISIT

Datatype

text

Alias
UMLS CUI [1,1]
C0205210
UMLS CUI [1,2]
C0441471
UMLS CUI [1,3]
C1301732
Blank Flag
Beschrijving

BLANK

Datatype

text

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

DCMDATE

Datatype

date

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

DOCNUM

Datatype

text

Alias
UMLS CUI [1, 1]
C2986015
Patient
Beschrijving

PATIENT

Datatype

text

Alias
UMLS CUI [1, 1]
C0030705
Questionnaire Date
Beschrijving

EXAMDT

Datatype

date

Alias
UMLS CUI [1, 1]
C0034394 C0011008
1. Over the last year, I have coughed:
Beschrijving

SGOLYC

Datatype

text

Alias
UMLS CUI [1, 1]
C3828179,C0439508
2. Over the last year, I have brought up phlegm:
Beschrijving

SGOLYP

Datatype

text

Alias
UMLS CUI [1, 1]
C3828181,C0439508
3. Over the last year, I have had shortness of breath:
Beschrijving

SGOLYS

Datatype

text

Alias
UMLS CUI [1, 1]
C3828161 C0439508
4. Over the last year, I have had attacks of wheezing:
Beschrijving

SGOLYW

Datatype

text

Alias
UMLS CUI [1, 1]
C3828162 C0439508
5. During the last year, how many severe...
Beschrijving

SGATT

Datatype

text

Alias
UMLS CUI [1, 1]
C3828156
6. How long did the worst attack...
Beschrijving

SGWAT

Datatype

text

Alias
UMLS CUI [1,1]
C3828155
UMLS CUI [1,2]
C3173993
7. Over the last year, in an average week,...
Beschrijving

SGGDY

Datatype

text

Alias
UMLS CUI [1, 1]
C3828163 C0332174 C0439508
8. If you have a wheeze, is it...
Beschrijving

SGWHZ

Datatype

text

Alias
UMLS CUI [1, 1]
C3828162
How would you describe your chest condition?
Beschrijving

SGCC

Datatype

text

Alias
UMLS CUI [1, 1]
C3828155 C3173999
If you ever had paid emplyment,...
Beschrijving

SGPE

Datatype

text

Alias
UMLS CUI [1, 1]
C3828155,C3174001
Sitting or lying still
Beschrijving

SGBRSL

Datatype

text

Alias
UMLS CUI [1, 1]
C3828155,C3843056
Getting washed or dressed
Beschrijving

SGBRWD

Datatype

text

Alias
UMLS CUI [1, 1]
C3828146
Walking around the home
Beschrijving

SGBRAH

Datatype

text

Alias
UMLS CUI [1, 1]
C3828155,C3843054
Walking outside on the level
Beschrijving

SGBRWL

Datatype

text

Alias
UMLS CUI [1, 1]
C3828155,C3843053
Walking up a flight of chairs
Beschrijving

SGBRFS

Datatype

text

Alias
UMLS CUI [1,1]
C3828167
Walking up hills
Beschrijving

SGBRWH

Datatype

text

Alias
UMLS CUI [1, 1]
C3828166
Playing sports or games
Beschrijving

SGBRSG

Datatype

text

Alias
UMLS CUI [1, 1]
C3828150
My cough hurts
Beschrijving

SGCOUH

Datatype

text

Alias
UMLS CUI [1, 1]
C3828177
My cough makes me tired
Beschrijving

SGCOUT

Datatype

text

Alias
UMLS CUI [1, 1]
C3828176
I am breathless when I talk
Beschrijving

SGCOUB

Datatype

text

Alias
UMLS CUI [1, 1]
C3828155,C3174007
I am breathless when bend over
Beschrijving

SGCOUV

Datatype

text

Alias
UMLS CUI [1, 1]
C3828155,C3174009
My cough or breathing...
Beschrijving

SGCOUS

Datatype

text

Alias
UMLS CUI [1, 1]
C3828155,C3174011
I get exhausted easily
Beschrijving

SGCOUE

Datatype

text

Alias
UMLS CUI [1, 1]
C3828164
My cough or breathing...
Beschrijving

SGCTEP

Datatype

text

Alias
UMLS CUI [1, 1]
C3828175
My chst trouble is a nuisance...
Beschrijving

SGCTNF

Datatype

text

Alias
UMLS CUI [1, 1]
C3828149
I get afraid or panic...
Beschrijving

SGCTAP

Datatype

text

Alias
UMLS CUI [1,1]
C3828183
I feel that I am not in control...
Beschrijving

SGCTNC

Datatype

text

Alias
UMLS CUI [1, 1]
C3828155,C3174021
I do not expect my chest...
Beschrijving

SGCTEB

Datatype

text

Alias
UMLS CUI [1, 1]
C3828155,C3174023
I have become frail...
Beschrijving

SGCTFI

Datatype

text

Alias
UMLS CUI [1, 1]
C3828182
Exercise is not safe for me
Beschrijving

SGCTES

Datatype

text

Alias
UMLS CUI [1, 1]
C3827215
Everything seems to much...
Beschrijving

SGCTME

Datatype

text

Alias
UMLS CUI [1,1]
C3828170
My medication does not help...
Beschrijving

SGMDNH

Datatype

text

Alias
UMLS CUI [1, 1]
C3828155,C3174031
I get emabarassed...
Beschrijving

SGMDEP

Datatype

text

Alias
UMLS CUI [1,1]
C3828155
UMLS CUI [1,2]
C3174033
I have unpleasant side effects...
Beschrijving

SGMDSE

Datatype

text

Alias
UMLS CUI [1, 1]
C3828155,C3174035
My medication interferes..
Beschrijving

SGMDIL

Datatype

text

Alias
UMLS CUI [1, 1]
C3828155,C3174037
I take a long time to get washed...
Beschrijving

SGACTWD

Datatype

text

Alias
UMLS CUI [1, 1]
C3828146
I cannot take a bath...
Beschrijving

SGACTBS

Datatype

text

Alias
UMLS CUI [1, 1]
C3828180
I walk slower...
Beschrijving

SGACTWS

Datatype

text

Alias
UMLS CUI [1, 1]
C3828145
Jobs such as housework...
Beschrijving

SGACTHL

Datatype

text

Alias
UMLS CUI [1, 1]
C3828155,C3174045
If I walk up one...
Beschrijving

SGACTFS

Datatype

text

Alias
UMLS CUI [1, 1]
C3828155,C3174047
If I hurry or walk fast...
Beschrijving

SGACTHW

Datatype

text

Alias
UMLS CUI [1, 1]
C3828159
My breathing makes it difficult...
Beschrijving

SGACTWC

Datatype

text

Alias
UMLS CUI [1, 1]
C3828155,C3174051
My breathing makes it difficult...
Beschrijving

SGACTCH

Datatype

text

Alias
UMLS CUI [1, 1]
C3828155,C3174053
My breathing makes it difficult...
Beschrijving

SGACTMW

Datatype

text

Alias
UMLS CUI [1, 1]
C3828155 C3174055
I cannot play sports or games
Beschrijving

SGADLSG

Datatype

text

Alias
UMLS CUI [1, 1]
C3828150
I cannot go out for ...
Beschrijving

SGADLER

Datatype

text

Alias
UMLS CUI [1,1]
C3828153
I cannot go out of the house...
Beschrijving

SGADLHS

Datatype

text

Alias
UMLS CUI [1, 1]
C3828152
I cannot do housework
Beschrijving

SGADLHW

Datatype

text

Alias
UMLS CUI [1, 1]
C3828155,C3174063
I cannot move far from my bed...
Beschrijving

SGADLBC

Datatype

text

Alias
UMLS CUI [1,1]
C3828151
Please write in any other (translation)
Beschrijving

SGCSTX

Datatype

text

Alias
UMLS CUI [1, 1]
C3828155,C3166810
Now, would you tick in the box...
Beschrijving

SGCHAF

Datatype

text

Alias
UMLS CUI [1,1]
C5237200
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Similar models

Description: St. George's Respiratory Questionnaire | Help Text: (P)

352 Formulieren
  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)
Datatype
Alias
Item Group
C0451500 (UMLS CUI [1,1])
LOCKED
Item
Locked
text
C3244297 (UMLS CUI [1, 1])
LAB
Item
Lab and lab range subset
text
C0022877 (UMLS CUI [1,1])
C0022877 (UMLS CUI [2,1])
C1514721 (UMLS CUI [2,2])
C1515021 (UMLS CUI [2,3])
QUALVAL
Item
Qualifying Value
text
C1514624,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 [1,2])
C1301732 (UMLS CUI [1,3])
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])
EXAMDT
Item
Questionnaire Date
date
C0034394 C0011008 (UMLS CUI [1, 1])
Item
1. Over the last year, I have coughed:
text
C3828179,C0439508 (UMLS CUI [1, 1])
SGOLYF-1
Code List
1. Over the last year, I have coughed:
CL Item
Most days a week (1)
C3840699 (UMLS CUI [1,1])
CL Item
Several days a week (2)
C3843492 (UMLS CUI [1,1])
CL Item
A few days a month (3)
C3843491 (UMLS CUI [1,1])
CL Item
Only w/chest infect (4)
C3843490 (UMLS CUI [1,1])
CL Item
Not at all (5)
C2984077 (UMLS CUI [1,1])
Item
2. Over the last year, I have brought up phlegm:
text
C3828181,C0439508 (UMLS CUI [1, 1])
SGOLYF-1
Code List
2. Over the last year, I have brought up phlegm:
CL Item
Most days a week (1)
C3840699 (UMLS CUI [1,1])
CL Item
Several days a week (2)
C3843492 (UMLS CUI [1,1])
CL Item
A few days a month (3)
C3843491 (UMLS CUI [1,1])
CL Item
Only w/chest infect (4)
C3843490 (UMLS CUI [1,1])
CL Item
Not at all (5)
C2984077 (UMLS CUI [1,1])
Item
3. Over the last year, I have had shortness of breath:
text
C3828161 C0439508 (UMLS CUI [1, 1])
SGOLYF-1
Code List
3. Over the last year, I have had shortness of breath:
CL Item
Most days a week (1)
C3840699 (UMLS CUI [1,1])
CL Item
Several days a week (2)
C3843492 (UMLS CUI [1,1])
CL Item
A few days a month (3)
C3843491 (UMLS CUI [1,1])
CL Item
Only w/chest infect (4)
C3843490 (UMLS CUI [1,1])
CL Item
Not at all (5)
C2984077 (UMLS CUI [1,1])
Item
4. Over the last year, I have had attacks of wheezing:
text
C3828162 C0439508 (UMLS CUI [1, 1])
SGOLYF-1
Code List
4. Over the last year, I have had attacks of wheezing:
CL Item
Most days a week (1)
C3840699 (UMLS CUI [1,1])
CL Item
Several days a week (2)
C3843492 (UMLS CUI [1,1])
CL Item
A few days a month (3)
C3843491 (UMLS CUI [1,1])
CL Item
Only w/chest infect (4)
C3843490 (UMLS CUI [1,1])
CL Item
Not at all (5)
C2984077 (UMLS CUI [1,1])
Item
5. During the last year, how many severe...
text
C3828156 (UMLS CUI [1, 1])
SGATTF-1
Code List
5. During the last year, how many severe...
CL Item
More than 3 attacks (1)
C3843489 (UMLS CUI [1,1])
CL Item
3 attacks (2)
C3843488 (UMLS CUI [1,1])
CL Item
2 attacks (3)
C3843487 (UMLS CUI [1,1])
CL Item
1 attack (4)
C1304680 (UMLS CUI [1,1])
CL Item
No attacks (5)
C3843485 (UMLS CUI [1,1])
Item
6. How long did the worst attack...
text
C3828155 (UMLS CUI [1,1])
C3173993 (UMLS CUI [1,2])
SGWATF-1
Code List
6. How long did the worst attack...
CL Item
1 week or more (1)
C3843484 (UMLS CUI [1,1])
CL Item
3 or more days (2)
C3843483 (UMLS CUI [1,1])
CL Item
1 or 2 days (3)
C3843997 (UMLS CUI [1,1])
CL Item
Less than a day (4)
C3843482 (UMLS CUI [1,1])
Item
7. Over the last year, in an average week,...
text
C3828163 C0332174 C0439508 (UMLS CUI [1, 1])
SGGDYF-1
Code List
7. Over the last year, in an average week,...
CL Item
No good days (1)
C3843481 (UMLS CUI [1,1])
CL Item
1 or 2 good days (2)
C3843480 (UMLS CUI [1,1])
CL Item
3 or 4 good days (3)
C3843479 (UMLS CUI [1,1])
CL Item
Near every day good (4)
C3840698 (UMLS CUI [1,1])
CL Item
Every day is good (5)
C3843478 (UMLS CUI [1,1])
Item
8. If you have a wheeze, is it...
text
C3828162 (UMLS CUI [1, 1])
YNF-1
Code List
8. If you have a wheeze, is it...
CL Item
No (0)
C1298908 (UMLS CUI [1,1])
CL Item
Yes (1)
C1705108 (UMLS CUI [1,1])
Item
How would you describe your chest condition?
text
C3828155 C3173999 (UMLS CUI [1, 1])
SGCCF-1
Code List
How would you describe your chest condition?
CL Item
Important problem (1)
C3843477 (UMLS CUI [1,1])
CL Item
Quite a lot problem (2)
C3843476 (UMLS CUI [1,1])
CL Item
Few problems (3)
C3843475 (UMLS CUI [1,1])
CL Item
No problem (4)
C3843474 (UMLS CUI [1,1])
Item
If you ever had paid emplyment,...
text
C3828155,C3174001 (UMLS CUI [1, 1])
SGPEF-1
Code List
If you ever had paid emplyment,...
CL Item
Stops work (1)
C3843473 (UMLS CUI [1,1])
CL Item
Interferes with work (2)
C3843471 (UMLS CUI [1,1])
CL Item
Not affects work (3)
C3843472 (UMLS CUI [1,1])
Item
Sitting or lying still
text
C3828155,C3843056 (UMLS CUI [1, 1])
TFF-1
Code List
Sitting or lying still
CL Item
False (0)
C0205237 (UMLS CUI [1,1])
CL Item
True (1)
C0205238 (UMLS CUI [1,1])
Item
Getting washed or dressed
text
C3828146 (UMLS CUI [1, 1])
TFF-1
Code List
Getting washed or dressed
CL Item
False (0)
C0205237 (UMLS CUI [1,1])
CL Item
True (1)
C0205238 (UMLS CUI [1,1])
Item
Walking around the home
text
C3828155,C3843054 (UMLS CUI [1, 1])
TFF-1
Code List
Walking around the home
CL Item
False (0)
C0205237 (UMLS CUI [1,1])
CL Item
True (1)
C0205238 (UMLS CUI [1,1])
Item
Walking outside on the level
text
C3828155,C3843053 (UMLS CUI [1, 1])
TFF-1
Code List
Walking outside on the level
CL Item
False (0)
C0205237 (UMLS CUI [1,1])
CL Item
True (1)
C0205238 (UMLS CUI [1,1])
Item
Walking up a flight of chairs
text
C3828167 (UMLS CUI [1,1])
TFF-1
Code List
Walking up a flight of chairs
CL Item
False (0)
C0205237 (UMLS CUI [1,1])
CL Item
True (1)
C0205238 (UMLS CUI [1,1])
Item
Walking up hills
text
C3828166 (UMLS CUI [1, 1])
TFF-1
Code List
Walking up hills
CL Item
False (0)
C0205237 (UMLS CUI [1,1])
CL Item
True (1)
C0205238 (UMLS CUI [1,1])
Item
Playing sports or games
text
C3828150 (UMLS CUI [1, 1])
TFF-1
Code List
Playing sports or games
CL Item
False (0)
C0205237 (UMLS CUI [1,1])
CL Item
True (1)
C0205238 (UMLS CUI [1,1])
Item
My cough hurts
text
C3828177 (UMLS CUI [1, 1])
TFF-1
Code List
My cough hurts
CL Item
False (0)
C0205237 (UMLS CUI [1,1])
CL Item
True (1)
C0205238 (UMLS CUI [1,1])
Item
My cough makes me tired
text
C3828176 (UMLS CUI [1, 1])
TFF-1
Code List
My cough makes me tired
CL Item
False (0)
C0205237 (UMLS CUI [1,1])
CL Item
True (1)
C0205238 (UMLS CUI [1,1])
Item
I am breathless when I talk
text
C3828155,C3174007 (UMLS CUI [1, 1])
TFF-1
Code List
I am breathless when I talk
CL Item
False (0)
C0205237 (UMLS CUI [1,1])
CL Item
True (1)
C0205238 (UMLS CUI [1,1])
Item
I am breathless when bend over
text
C3828155,C3174009 (UMLS CUI [1, 1])
TFF-1
Code List
I am breathless when bend over
CL Item
False (0)
C0205237 (UMLS CUI [1,1])
CL Item
True (1)
C0205238 (UMLS CUI [1,1])
Item
My cough or breathing...
text
C3828155,C3174011 (UMLS CUI [1, 1])
TFF-1
Code List
My cough or breathing...
CL Item
False (0)
C0205237 (UMLS CUI [1,1])
CL Item
True (1)
C0205238 (UMLS CUI [1,1])
Item
I get exhausted easily
text
C3828164 (UMLS CUI [1, 1])
TFF-1
Code List
I get exhausted easily
CL Item
False (0)
C0205237 (UMLS CUI [1,1])
CL Item
True (1)
C0205238 (UMLS CUI [1,1])
Item
My cough or breathing...
text
C3828175 (UMLS CUI [1, 1])
TFF-1
Code List
My cough or breathing...
CL Item
False (0)
C0205237 (UMLS CUI [1,1])
CL Item
True (1)
C0205238 (UMLS CUI [1,1])
Item
My chst trouble is a nuisance...
text
C3828149 (UMLS CUI [1, 1])
TFF-1
Code List
My chst trouble is a nuisance...
CL Item
False (0)
C0205237 (UMLS CUI [1,1])
CL Item
True (1)
C0205238 (UMLS CUI [1,1])
Item
I get afraid or panic...
text
C3828183 (UMLS CUI [1,1])
TFF-1
Code List
I get afraid or panic...
CL Item
False (0)
C0205237 (UMLS CUI [1,1])
CL Item
True (1)
C0205238 (UMLS CUI [1,1])
Item
I feel that I am not in control...
text
C3828155,C3174021 (UMLS CUI [1, 1])
TFF-1
Code List
I feel that I am not in control...
CL Item
False (0)
C0205237 (UMLS CUI [1,1])
CL Item
True (1)
C0205238 (UMLS CUI [1,1])
Item
I do not expect my chest...
text
C3828155,C3174023 (UMLS CUI [1, 1])
TFF-1
Code List
I do not expect my chest...
CL Item
False (0)
C0205237 (UMLS CUI [1,1])
CL Item
True (1)
C0205238 (UMLS CUI [1,1])
Item
I have become frail...
text
C3828182 (UMLS CUI [1, 1])
TFF-1
Code List
I have become frail...
CL Item
False (0)
C0205237 (UMLS CUI [1,1])
CL Item
True (1)
C0205238 (UMLS CUI [1,1])
Item
Exercise is not safe for me
text
C3827215 (UMLS CUI [1, 1])
TFF-1
Code List
Exercise is not safe for me
CL Item
False (0)
C0205237 (UMLS CUI [1,1])
CL Item
True (1)
C0205238 (UMLS CUI [1,1])
Item
Everything seems to much...
text
C3828170 (UMLS CUI [1,1])
TFF-1
Code List
Everything seems to much...
CL Item
False (0)
C0205237 (UMLS CUI [1,1])
CL Item
True (1)
C0205238 (UMLS CUI [1,1])
Item
My medication does not help...
text
C3828155,C3174031 (UMLS CUI [1, 1])
TFF-1
Code List
My medication does not help...
CL Item
False (0)
C0205237 (UMLS CUI [1,1])
CL Item
True (1)
C0205238 (UMLS CUI [1,1])
Item
I get emabarassed...
text
C3828155 (UMLS CUI [1,1])
C3174033 (UMLS CUI [1,2])
TFF-1
Code List
I get emabarassed...
CL Item
False (0)
C0205237 (UMLS CUI [1,1])
CL Item
True (1)
C0205238 (UMLS CUI [1,1])
Item
I have unpleasant side effects...
text
C3828155,C3174035 (UMLS CUI [1, 1])
TFF-1
Code List
I have unpleasant side effects...
CL Item
False (0)
C0205237 (UMLS CUI [1,1])
CL Item
True (1)
C0205238 (UMLS CUI [1,1])
Item
My medication interferes..
text
C3828155,C3174037 (UMLS CUI [1, 1])
TFF-1
Code List
My medication interferes..
CL Item
False (0)
C0205237 (UMLS CUI [1,1])
CL Item
True (1)
C0205238 (UMLS CUI [1,1])
Item
I take a long time to get washed...
text
C3828146 (UMLS CUI [1, 1])
TFF-1
Code List
I take a long time to get washed...
CL Item
False (0)
C0205237 (UMLS CUI [1,1])
CL Item
True (1)
C0205238 (UMLS CUI [1,1])
Item
I cannot take a bath...
text
C3828180 (UMLS CUI [1, 1])
TFF-1
Code List
I cannot take a bath...
CL Item
False (0)
C0205237 (UMLS CUI [1,1])
CL Item
True (1)
C0205238 (UMLS CUI [1,1])
Item
I walk slower...
text
C3828145 (UMLS CUI [1, 1])
TFF-1
Code List
I walk slower...
CL Item
False (0)
C0205237 (UMLS CUI [1,1])
CL Item
True (1)
C0205238 (UMLS CUI [1,1])
Item
Jobs such as housework...
text
C3828155,C3174045 (UMLS CUI [1, 1])
TFF-1
Code List
Jobs such as housework...
CL Item
False (0)
C0205237 (UMLS CUI [1,1])
CL Item
True (1)
C0205238 (UMLS CUI [1,1])
Item
If I walk up one...
text
C3828155,C3174047 (UMLS CUI [1, 1])
TFF-1
Code List
If I walk up one...
CL Item
False (0)
C0205237 (UMLS CUI [1,1])
CL Item
True (1)
C0205238 (UMLS CUI [1,1])
Item
If I hurry or walk fast...
text
C3828159 (UMLS CUI [1, 1])
TFF-1
Code List
If I hurry or walk fast...
CL Item
False (0)
C0205237 (UMLS CUI [1,1])
CL Item
True (1)
C0205238 (UMLS CUI [1,1])
Item
My breathing makes it difficult...
text
C3828155,C3174051 (UMLS CUI [1, 1])
TFF-1
Code List
My breathing makes it difficult...
CL Item
False (0)
C0205237 (UMLS CUI [1,1])
CL Item
True (1)
C0205238 (UMLS CUI [1,1])
Item
My breathing makes it difficult...
text
C3828155,C3174053 (UMLS CUI [1, 1])
TFF-1
Code List
My breathing makes it difficult...
CL Item
False (0)
C0205237 (UMLS CUI [1,1])
CL Item
True (1)
C0205238 (UMLS CUI [1,1])
Item
My breathing makes it difficult...
text
C3828155 C3174055 (UMLS CUI [1, 1])
TFF-1
Code List
My breathing makes it difficult...
CL Item
False (0)
C0205237 (UMLS CUI [1,1])
CL Item
True (1)
C0205238 (UMLS CUI [1,1])
Item
I cannot play sports or games
text
C3828150 (UMLS CUI [1, 1])
TFF-1
Code List
I cannot play sports or games
CL Item
False (0)
C0205237 (UMLS CUI [1,1])
CL Item
True (1)
C0205238 (UMLS CUI [1,1])
Item
I cannot go out for ...
text
C3828153 (UMLS CUI [1,1])
TFF-1
Code List
I cannot go out for ...
CL Item
False (0)
C0205237 (UMLS CUI [1,1])
CL Item
True (1)
C0205238 (UMLS CUI [1,1])
Item
I cannot go out of the house...
text
C3828152 (UMLS CUI [1, 1])
TFF-1
Code List
I cannot go out of the house...
CL Item
False (0)
C0205237 (UMLS CUI [1,1])
CL Item
True (1)
C0205238 (UMLS CUI [1,1])
Item
I cannot do housework
text
C3828155,C3174063 (UMLS CUI [1, 1])
TFF-1
Code List
I cannot do housework
CL Item
False (0)
C0205237 (UMLS CUI [1,1])
CL Item
True (1)
C0205238 (UMLS CUI [1,1])
Item
I cannot move far from my bed...
text
C3828151 (UMLS CUI [1,1])
TFF-1
Code List
I cannot move far from my bed...
CL Item
False (0)
C0205237 (UMLS CUI [1,1])
CL Item
True (1)
C0205238 (UMLS CUI [1,1])
SGCSTX
Item
Please write in any other (translation)
text
C3828155,C3166810 (UMLS CUI [1, 1])
Item
Now, would you tick in the box...
text
C5237200 (UMLS CUI [1,1])
SGCHAFF-1
Code List
Now, would you tick in the box...
CL Item
Not stop anything (1)
C3843470 (UMLS CUI [1,1])
CL Item
Stop 1-2 things (2)
C3843469 (UMLS CUI [1,1])
CL Item
Stop most thing (3)
C3843468 (UMLS CUI [1,1])
CL Item
Stop everything (4)
C3843467 (UMLS CUI [1,1])
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