Engelsk

Description: Information from IVRS

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)
IVRCK
Beskrivning

IVRCK

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
Date of Randomisation
Beskrivning

PDRANDDT

Datatyp

date

Alias
UMLS CUI [1, 1]
C0011008
UMLS CUI [1,1]
C0034656
Sex
Beskrivning

SEX

Datatyp

text

Alias
UMLS CUI [1, 1]
C0079399
Dose Reduction reported at V9
Beskrivning

DOSRED

Datatyp

text

Alias
UMLS CUI [1, 1]
C1707814
Date of Birth
Beskrivning

BTHYMD

Datatyp

date

Alias
UMLS CUI [1, 1]
C0421451
BTHDT
Beskrivning

BTHDT

Datatyp

date

Alias
UMLS CUI [1,1]
C3846158
LOT
Beskrivning

LOT

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]
C0011008
Document Number
Beskrivning

DOCNUM

Datatyp

text

Alias
UMLS CUI [1, 1]
C2986015
Patient
Beskrivning

PATIENT

Datatyp

text

Alias
UMLS CUI [1, 1]
C0030705
Medication Lot Number
Beskrivning

LOTNO

Datatyp

text

Alias
UMLS CUI [1, 1]
C1115660
UMLS CUI [1,1]
C0013227
Medication Lot Number Change Date
Beskrivning

LOTDT

Datatyp

date

Alias
UMLS CUI [1, 1]
C1115660
UMLS CUI [1,1]
C0392747
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0011008
Visit Number
Beskrivning

VISNO

Datatyp

integer

Alias
UMLS CUI [1, 1]
C0545082
UMLS CUI [1,1]
C0237753
Kit status
Beskrivning

PTSX

Datatyp

text

Alias
UMLS CUI [1, 1]
C0449438
Tillbaka till toppen

Similar models

Description: Information from IVRS

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
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])
PDRANDDT
Item
Date of Randomisation
date
C0011008 (UMLS CUI [1, 1])
C0034656 (UMLS CUI [1,1])
Item
Sex
text
C0079399 (UMLS CUI [1, 1])
SEXF-1
Code List
Sex
CL Item
Male (1)
C1706180 (UMLS CUI [1,1])
CL Item
Female (2)
C3887375 (UMLS CUI [1,1])
Item
Dose Reduction reported at V9
text
C1707814 (UMLS CUI [1, 1])
YNF-1
Code List
Dose Reduction reported at V9
CL Item
No (0)
C1298908 (UMLS CUI [1,1])
CL Item
Yes (1)
C1705108 (UMLS CUI [1,1])
BTHYMD
Item
Date of Birth
date
C0421451 (UMLS CUI [1, 1])
BTHDT
Item
date
C3846158 (UMLS CUI [1,1])
Item Group
LOCKED
Item
Locked
text
C3244297 (UMLS CUI [1, 1])
LAB
Item
Lab and lab range subset
text
C0022877 (UMLS CUI [1, 1])
C0022877 (UMLS CUI [2,1])
C1514721 (UMLS CUI [2,2])
C1515021 (UMLS CUI [2,3])
QUALVAL
Item
Qualifying Value
text
C1514624 (UMLS CUI [1, 1])
C1522609 (UMLS CUI [1,1])
HEADCMT
Item
Header Comment
text
C0947611 (UMLS CUI [1, 1])
INV
Item
Investigator
text
C0035173 (UMLS CUI [1, 1])
SITE
Item
Site
text
C0205145 (UMLS CUI [1, 1])
SUBVISIT
Item
Subevent
text
C2983704 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
VISIT
Item
Clinical Planned Event
text
C0205210 (UMLS CUI [1, 1])
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
C0011008 (UMLS CUI [1,1])
DOCNUM
Item
Document Number
text
C2986015 (UMLS CUI [1, 1])
PATIENT
Item
Patient
text
C0030705 (UMLS CUI [1, 1])
LOTNO
Item
Medication Lot Number
text
C1115660 (UMLS CUI [1, 1])
C0013227 (UMLS CUI [1,1])
LOTDT
Item
Medication Lot Number Change Date
date
C1115660 (UMLS CUI [1, 1])
C0392747 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
VISNO
Item
Visit Number
integer
C0545082 (UMLS CUI [1, 1])
C0237753 (UMLS CUI [1,1])
PTSX
Item
Kit status
text
C0449438 (UMLS CUI [1, 1])
Tillbaka till toppen