ID

45974

Beskrivning

The general purpose of this trial is to investigate the efficacy and safety of 4 dose strategies of BIBF 1120 treatment for 12 months, compared to placebo in patients with idiopathic pulmonary fibrosis. The primary objective of this study is to demonstrate whether at least one dose strategy is superior to placebo in patients with IPF, in modifying the rate of decline of Forced Vital Capacity (FVC). As a secondary objective, additional parameters will be assessed in order to differentiate between dose strategies on the basis of safety and efficacy

Länk

NCT00514683

Nyckelord

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

Boehringer Ingelheim

Uppladdad den

28 mars 2024

DOI

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Licens

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

Engelsk

Description: Concomitant Diagnosis / Baseline Conditions | Help Text: (S)

352 Formulär  
  1. StudyEvent: CUM_AE
    1. Description: Adverse Event | Help Text: (S)
    2. Description: Physical Examination ECOG score only | Help Text: (P)
    3. Description: Concomitant Therapies | Help Text: (S)
    4. Description: Areterial Blood Gases
    5. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
  2. StudyEvent: CUM_CT
    1. Description: Concomitant Therapies | Help Text: (S)
    2. Description: Study Medication (BIBF)
    3. Description: Adverse Event | Help Text: (S)
    4. Description: Termination of Period/Trial Medication | Help Text: (S)
    5. Description: Administration of BIBF Before | Help Text: (P) PKADM
    6. Description: Medication Compliance
    7. Description: Patient Eligibility | Help Text: (S)
  3. StudyEvent: TRT CHANGE
    1. Description: Study Medication (BIBF)
  4. StudyEvent: IVRS
    1. Description: Information from IVRS
  5. StudyEvent: VISIT 1
    1. Description: Patient Demographics | Help Text: (S)
    2. Description: Physical Examination (Screening) | Help Text: (P)
    3. Description: Concomitant Diagnosis / Baseline Conditions | Help Text: (S)
    4. Description: Six minutes walking test
    5. Description: Lab samples taken | Help Text: (O)
    6. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    7. Description: Pregnancy test | Help Text: (P)
    8. Description: ECG at screening | Help Text: (P)
    9. Description: Lab samples taken | Help Text: (O)
    10. Description: Lab Batch | Help Text: (O)
    11. Description: Pulmonary Function Testing | Help Text: (P)
    12. Description: Diagnosis of IPF
    13. Description: Inclusion/Exclusion Criteria | Help Text: (S)
    14. Description: Patient Eligibility | Help Text: (S)
    15. Description: Physical Examination ECOG score only | Help Text: (P)
    16. Description: Determination of DLco
    17. Description: Areterial Blood Gases
    18. Description: Concomitant Therapies | Help Text: (S)
    19. Description: Lab samples taken | Help Text: (O)
    20. Description: St. George's Respiratory Questionnaire | Help Text: (P)
    21. Description: Medical research council dyspnoea score
    22. Description: Physical Examination (except V3 V5) | Help Text: (P)
    23. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    24. Description: Substance measurement at time point | Help Text: (P)
    25. Description: Pharmacokinetic parameter PD | Help Text: (P)
  6. StudyEvent: VISIT 2
    1. Description: Diagnosis of IPF
    2. Description: Physical Examination (except V3 V5) | Help Text: (P)
    3. Description: St. George's Respiratory Questionnaire | Help Text: (P)
    4. Description: Medical research council dyspnoea score
    5. Description: Lab samples taken | Help Text: (O)
    6. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    7. Description: genetic informed conset
    8. Description: Pregnancy test | Help Text: (P)
    9. Description: Lab samples taken | Help Text: (O)
    10. Description: Pulmonary Function Testing | Help Text: (P)
    11. Description: Determination of DLco
    12. Description: Areterial Blood Gases
    13. Description: Six minutes walking test
    14. Description: Inclusion/Exclusion Criteria | Help Text: (S)
    15. Description: Patient Eligibility | Help Text: (S)
    16. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    17. Description: Administration of BIBF now (not used) | Help Text: (P) PKADM
    18. Description: Lab Batch | Help Text: (O)
    19. Description: Pulmonary Function Testing | Help Text: (P)
    20. Description: Administration of BIBF now | Help Text: (P) PKADM
    21. Description: Concomitant Therapies | Help Text: (S)
    22. Description: Assigned Medication Number(s) from Label(s)
    23. Description: Assigned Medication Number(s) from Label(s)
    24. Description: Substance measurement at time point | Help Text: (P)
    25. Description: Pharmacokinetic parameter | Help Text: (P)
    26. Description: Pharmacokinetic parameter PD | Help Text: (P)
  7. StudyEvent: VISIT 3
    1. Description: Medication Compliance
    2. Description: Physical Examination ECOG score only | Help Text: (P)
    3. Description: ECG | Help Text: (P)
    4. Description: Lab samples taken | Help Text: (O)
    5. Description: Lab samples taken | Help Text: (O)
    6. Description: Pulmonary Function Testing | Help Text: (P)
    7. Description: Lab Batch | Help Text: (O)
    8. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    9. Description: Substance measurement at time point | Help Text: (P)
  8. StudyEvent: VISIT 4
    1. Description: Medication Compliance
    2. Description: Administration of BIBF Before (not used) | Help Text: (P) PKADM
    3. Description: Physical Examination (except V3 V5) | Help Text: (P)
    4. Description: ECG | Help Text: (P)
    5. Description: Lab samples taken | Help Text: (O)
    6. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    7. Description: Lab samples taken | Help Text: (O)
    8. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    9. Description: Assigned Medication Number(s) from Label(s)
    10. Description: Lab Batch | Help Text: (O)
    11. Description: Administration of BIBF now (not used) | Help Text: (P) PKADM
    12. Description: Pulmonary Function Testing | Help Text: (P)
    13. Description: Administration of BIBF Before | Help Text: (P) PKADM
    14. Description: Administration of BIBF now | Help Text: (P) PKADM
    15. Description: genetic informed conset
    16. Description: Substance measurement at time point | Help Text: (P)
    17. Description: Pharmacokinetic parameter | Help Text: (P)
    18. Description: Pharmacokinetic parameter PD | Help Text: (P)
  9. StudyEvent: VISIT 5
    1. Description: Medication Compliance
    2. Description: Physical Examination ECOG score only | Help Text: (P)
    3. Description: Lab samples taken | Help Text: (O)
    4. Description: Lab samples taken | Help Text: (O)
    5. Description: Lab Batch | Help Text: (O)
    6. Description: Pulmonary Function Testing | Help Text: (P)
    7. Description: Administration of BIBF now | Help Text: (P) PKADM
    8. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    9. Description: Administration of BIBF Before | Help Text: (P) PKADM
    10. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    11. Description: Substance measurement at time point | Help Text: (P)
  10. StudyEvent: VISIT 6
    1. Description: Medication Compliance
    2. Description: Physical Examination (except V3 V5) | Help Text: (P)
    3. Description: St. George's Respiratory Questionnaire | Help Text: (P)
    4. Description: Medical research council dyspnoea score
    5. Description: ECG | Help Text: (P)
    6. Description: Lab samples taken | Help Text: (O)
    7. Description: Pregnancy test | Help Text: (P)
    8. Description: Lab samples taken | Help Text: (O)
    9. Description: Assigned Medication Number(s) from Label(s)
    10. Description: Lab Batch | Help Text: (O)
    11. Description: Pulmonary Function Testing | Help Text: (P)
    12. Description: Adverse Event | Help Text: (S)
    13. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    14. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    15. Description: Administration of BIBF now | Help Text: (P) PKADM
    16. Description: Substance measurement at time point | Help Text: (P)
  11. StudyEvent: VISIT 6A
    1. Description: Lab samples taken | Help Text: (O)
    2. Description: Lab Batch | Help Text: (O)
    3. Description: Six minutes walking test
    4. Description: Areterial Blood Gases
    5. Description: Pulmonary Function Testing | Help Text: (P)
    6. Description: Determination of DLco
    7. Description: Pulmonary Function Testing | Help Text: (P)
  12. StudyEvent: VISIT 7
    1. Description: Medication Compliance
    2. Description: Administration of BIBF Before | Help Text: (P) PKADM
    3. Description: Physical Examination (except V3 V5) | Help Text: (P)
    4. Description: St. George's Respiratory Questionnaire | Help Text: (P)
    5. Description: Medical research council dyspnoea score
    6. Description: ECG | Help Text: (P)
    7. Description: Lab samples taken | Help Text: (O)
    8. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    9. Description: Pregnancy test | Help Text: (P)
    10. Description: Lab samples taken | Help Text: (O)
    11. Description: Pulmonary Function Testing | Help Text: (P)
    12. Description: Six minutes walking test
    13. Description: Determination of DLco
    14. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    15. Description: Administration of BIBF now | Help Text: (P) PKADM
    16. Description: Assigned Medication Number(s) from Label(s)
    17. Description: Lab Batch | Help Text: (O)
    18. Description: Pulmonary Function Testing | Help Text: (P)
    19. Description: Areterial Blood Gases
    20. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    21. Description: Substance measurement at time point | Help Text: (P)
    22. Description: Pharmacokinetic parameter | Help Text: (P)
    23. Description: Pharmacokinetic parameter PD | Help Text: (P)
  13. StudyEvent: VISIT 7A
    1. Description: Lab samples taken | Help Text: (O)
    2. Description: Lab Batch | Help Text: (O)
    3. Description: Six minutes walking test
    4. Description: Pulmonary Function Testing | Help Text: (P)
    5. Description: Determination of DLco
  14. StudyEvent: VISIT 8
    1. Description: Medication Compliance
    2. Description: Physical Examination (except V3 V5) | Help Text: (P)
    3. Description: ECG | Help Text: (P)
    4. Description: Lab samples taken | Help Text: (O)
    5. Description: Pregnancy test | Help Text: (P)
    6. Description: Lab samples taken | Help Text: (O)
    7. Description: Assigned Medication Number(s) from Label(s)
    8. Description: Lab Batch | Help Text: (O)
    9. Description: Pulmonary Function Testing | Help Text: (P)
    10. Description: Determination of DLco
    11. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    12. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    13. Description: Substance measurement at time point | Help Text: (P)
  15. StudyEvent: VISIT 8A
    1. Description: Lab Batch | Help Text: (O)
    2. Description: Lab samples taken | Help Text: (O)
    3. Description: Physical Examination ECOG score only | Help Text: (P)
    4. Description: Pulmonary Function Testing | Help Text: (P)
  16. StudyEvent: VISIT 9
    1. Description: Medication Compliance
    2. Description: Administration of BIBF Before | Help Text: (P) PKADM
    3. Description: Physical Examination (except V3 V5) | Help Text: (P)
    4. Description: St. George's Respiratory Questionnaire | Help Text: (P)
    5. Description: Medical research council dyspnoea score
    6. Description: Lab samples taken | Help Text: (O)
    7. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    8. Description: Pregnancy test | Help Text: (P)
    9. Description: Lab samples taken | Help Text: (O)
    10. Description: Pulmonary Function Testing | Help Text: (P)
    11. Description: Six minutes walking test
    12. Description: Determination of DLco
    13. Description: Areterial Blood Gases
    14. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    15. Description: Administration of BIBF now | Help Text: (P) PKADM
    16. Description: Lab Batch | Help Text: (O)
    17. Description: Pulmonary Function Testing | Help Text: (P)
    18. Description: ECG | Help Text: (P)
    19. Description: Substance measurement at time point | Help Text: (P)
    20. Description: Pharmacokinetic parameter | Help Text: (P)
    21. Description: Pharmacokinetic parameter PD | Help Text: (P)
  17. StudyEvent: END TRT 1
    1. Description: Termination of Period/Trial Medication | Help Text: (S)
    2. Description: Assigned Medication Number(s) from Label(s)
    3. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
  18. StudyEvent: VISIT 10
    1. Description: Administration of BIBF Before | Help Text: (P) PKADM
    2. Description: Medication Compliance
    3. Description: Physical Examination (except V3 V5) | Help Text: (P)
    4. Description: ECG | Help Text: (P)
    5. Description: Lab samples taken | Help Text: (O)
    6. Description: Pregnancy test | Help Text: (P)
    7. Description: Lab samples taken | Help Text: (O)
    8. Description: Lab Batch | Help Text: (O)
    9. Description: Pulmonary Function Testing | Help Text: (P)
    10. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    11. Description: Substance measurement at time point | Help Text: (P)
  19. StudyEvent: VISIT 11
    1. Description: Medication Compliance
    2. Description: Physical Examination (except V3 V5) | Help Text: (P)
    3. Description: ECG | Help Text: (P)
    4. Description: Lab samples taken | Help Text: (O)
    5. Description: Pregnancy test | Help Text: (P)
    6. Description: Lab samples taken | Help Text: (O)
    7. Description: Assigned Medication Number(s) from Label(s)
    8. Description: Pulmonary Function Testing | Help Text: (P)
    9. Description: Lab Batch | Help Text: (O)
    10. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    11. Description: Substance measurement at time point | Help Text: (P)
  20. StudyEvent: VISIT 12
    1. Description: Medication Compliance
    2. Description: Physical Examination (except V3 V5) | Help Text: (P)
    3. Description: ECG | Help Text: (P)
    4. Description: Lab samples taken | Help Text: (O)
    5. Description: Pregnancy test | Help Text: (P)
    6. Description: Lab samples taken | Help Text: (O)
    7. Description: Assigned Medication Number(s) from Label(s)
    8. Description: Pulmonary Function Testing | Help Text: (P)
    9. Description: Lab Batch | Help Text: (O)
    10. Description: Pulmonary Function Testing | Help Text: (P)
    11. Description: Areterial Blood Gases
    12. Description: Determination of DLco
    13. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    14. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    15. Description: Substance measurement at time point | Help Text: (P)
  21. StudyEvent: VISIT 12A
    1. Description: Lab Batch | Help Text: (O)
    2. Description: Lab samples taken | Help Text: (O)
    3. Description: ECG | Help Text: (P)
    4. Description: Lab samples taken | Help Text: (O)
    5. Description: Pulmonary Function Testing | Help Text: (P)
  22. StudyEvent: VISIT 13
    1. Description: Medication Compliance
    2. Description: Physical Examination (except V3 V5) | Help Text: (P)
    3. Description: ECG | Help Text: (P)
    4. Description: Lab samples taken | Help Text: (O)
    5. Description: Pregnancy test | Help Text: (P)
    6. Description: Lab samples taken | Help Text: (O)
    7. Description: Determination of DLco
    8. Description: Assigned Medication Number(s) from Label(s)
    9. Description: Pulmonary Function Testing | Help Text: (P)
    10. Description: Lab Batch | Help Text: (O)
    11. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    12. Description: Substance measurement at time point | Help Text: (P)
  23. StudyEvent: VISIT 13A
    1. Description: Lab samples taken | Help Text: (O)
    2. Description: Lab Batch | Help Text: (O)
    3. Description: ECG | Help Text: (P)
  24. StudyEvent: VISIT 13B
    1. Description: Lab samples taken | Help Text: (O)
    2. Description: Lab Batch | Help Text: (O)
  25. StudyEvent: VISIT 13C
    1. Description: Lab Batch | Help Text: (O)
    2. Description: Lab samples taken | Help Text: (O)
    3. Description: Concomitant Therapies | Help Text: (S)
    4. Description: Physical Examination ECOG score only | Help Text: (P)
  26. StudyEvent: VISIT 14
    1. Description: Medication Compliance
    2. Description: Physical Examination (except V3 V5) | Help Text: (P)
    3. Description: ECG | Help Text: (P)
    4. Description: Lab samples taken | Help Text: (O)
    5. Description: Pregnancy test | Help Text: (P)
    6. Description: Lab samples taken | Help Text: (O)
    7. Description: Determination of DLco
    8. Description: Assigned Medication Number(s) from Label(s)
    9. Description: Pulmonary Function Testing | Help Text: (P)
    10. Description: Lab Batch | Help Text: (O)
  27. StudyEvent: VISIT 14A
    1. Description: Lab samples taken | Help Text: (O)
    2. Description: Lab Batch | Help Text: (O)
  28. StudyEvent: VISIT 14B
    1. Description: Lab samples taken | Help Text: (O)
    2. Description: Lab Batch | Help Text: (O)
    3. Description: Pulmonary Function Testing | Help Text: (P)
  29. StudyEvent: VISIT 14C
    1. Description: Lab samples taken | Help Text: (O)
    2. Description: Lab Batch | Help Text: (O)
  30. StudyEvent: VISIT 15
    1. Description: Medication Compliance
    2. Description: Physical Examination (except V3 V5) | Help Text: (P)
    3. Description: ECG | Help Text: (P)
    4. Description: Lab samples taken | Help Text: (O)
    5. Description: Pregnancy test | Help Text: (P)
    6. Description: Lab samples taken | Help Text: (O)
    7. Description: Determination of DLco
    8. Description: Assigned Medication Number(s) from Label(s)
    9. Description: Lab Batch | Help Text: (O)
    10. Description: Pulmonary Function Testing | Help Text: (P)
  31. StudyEvent: VISIT 15A
    1. Description: Lab Batch | Help Text: (O)
    2. Description: Lab samples taken | Help Text: (O)
  32. StudyEvent: VISIT 15B
    1. Description: Lab samples taken | Help Text: (O)
    2. Description: Lab Batch | Help Text: (O)
  33. StudyEvent: VISIT 15C
    1. Description: Lab samples taken | Help Text: (O)
    2. Description: Lab Batch | Help Text: (O)
  34. StudyEvent: VISIT 16
    1. Description: Medication Compliance
    2. Description: Physical Examination (except V3 V5) | Help Text: (P)
    3. Description: ECG | Help Text: (P)
    4. Description: Lab samples taken | Help Text: (O)
    5. Description: Pregnancy test | Help Text: (P)
    6. Description: Lab samples taken | Help Text: (O)
    7. Description: Determination of DLco
    8. Description: Assigned Medication Number(s) from Label(s)
    9. Description: Pulmonary Function Testing | Help Text: (P)
    10. Description: Lab Batch | Help Text: (O)
  35. StudyEvent: VISIT 16A
    1. Description: Lab samples taken | Help Text: (O)
    2. Description: Lab Batch | Help Text: (O)
  36. StudyEvent: VISIT 16B
    1. Description: Lab samples taken | Help Text: (O)
    2. Description: Lab Batch | Help Text: (O)
  37. StudyEvent: VISIT 16C
    1. Description: Lab samples taken | Help Text: (O)
    2. Description: Lab Batch | Help Text: (O)
  38. StudyEvent: END TRT 2
    1. Description: Termination of Period/Trial Medication | Help Text: (S)
    2. Description: Patient Vital Status | Help Text: (O)
  39. StudyEvent: EOT
    1. Description: Medication Compliance
    2. Description: Physical Examination (except V3 V5) | Help Text: (P)
    3. Description: ECG | Help Text: (P)
    4. Description: Lab samples taken | Help Text: (O)
    5. Description: Pregnancy test | Help Text: (P)
    6. Description: Lab samples taken | Help Text: (O)
    7. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    8. Description: Lab Batch | Help Text: (O)
    9. Description: Pulmonary Function Testing | Help Text: (P)
    10. Description: St. George's Respiratory Questionnaire | Help Text: (P)
    11. Description: Medical research council dyspnoea score
    12. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    13. Description: Pulmonary Function Testing | Help Text: (P)
    14. Description: Six minutes walking test
    15. Description: Determination of DLco
    16. Description: Areterial Blood Gases
    17. Description: Substance measurement at time point | Help Text: (P)
  40. StudyEvent: FOLLOWUP
    1. Description: Physical Examination (except V3 V5) | Help Text: (P)
    2. Description: Patient Vital Status | Help Text: (O)
    3. Description: Lab samples taken | Help Text: (O)
  41. StudyEvent: DISC V4
    1. Description: Physical Examination ECOG score only | Help Text: (P)
    2. Description: Lab samples taken | Help Text: (O)
    3. Description: Pulmonary Function Testing | Help Text: (P)
  42. StudyEvent: DISC V5
    1. Description: Physical Examination ECOG score only | Help Text: (P)
    2. Description: Lab samples taken | Help Text: (O)
    3. Description: Pulmonary Function Testing | Help Text: (P)
  43. StudyEvent: DISC V6
    1. Description: Physical Examination ECOG score only | Help Text: (P)
    2. Description: Lab samples taken | Help Text: (O)
    3. Description: Pulmonary Function Testing | Help Text: (P)
  44. StudyEvent: DISC V7
    1. Description: Physical Examination ECOG score only | Help Text: (P)
    2. Description: Lab samples taken | Help Text: (O)
    3. Description: Pulmonary Function Testing | Help Text: (P)
  45. StudyEvent: DISC V8
    1. Description: Physical Examination ECOG score only | Help Text: (P)
    2. Description: Lab samples taken | Help Text: (O)
    3. Description: Pulmonary Function Testing | Help Text: (P)
    4. Description: Lab samples taken | Help Text: (O)
  46. StudyEvent: DISC V9
    1. Description: Physical Examination ECOG score only | Help Text: (P)
    2. Description: Lab samples taken | Help Text: (O)
    3. Description: Pulmonary Function Testing | Help Text: (P)
    4. Description: Pulmonary Function Testing | Help Text: (P)
  47. StudyEvent: COMPLETION
    1. Description: Trial Completion | Help Text: (O)
    2. Description: Patient Vital Status | Help Text: (O)
    3. Description: Physical Examination ECOG score only | Help Text: (P)
CDB
Beskrivning

CDB

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 [1, 2]
C1515021
UMLS CUI [1,1]
C1514721
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
Does the patient have any baseline conditions?
Beskrivning

CDI

Datatyp

text

Alias
UMLS CUI [1, 1]
C1442488
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0478635
Condition / Diagnosis
Beskrivning

CDMX

Datatyp

text

Alias
UMLS CUI [1, 1]
C0478635
Relevant Additional Information
Beskrivning

CDADDX

Datatyp

text

Alias
UMLS CUI [1, 1]
C1546922
CDLLT
Beskrivning

CDLLT

Datatyp

text

Alias
UMLS CUI [1,1]
C3846158
CDLLTCD
Beskrivning

CDLLTCD

Datatyp

text

Alias
UMLS CUI [1,1]
C3846158
Tillbaka till toppen

Similar models

Description: Concomitant Diagnosis / Baseline Conditions | Help Text: (S)

352 Formulär
  1. StudyEvent: CUM_AE
    1. Description: Adverse Event | Help Text: (S)
    2. Description: Physical Examination ECOG score only | Help Text: (P)
    3. Description: Concomitant Therapies | Help Text: (S)
    4. Description: Areterial Blood Gases
    5. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
  2. StudyEvent: CUM_CT
    1. Description: Concomitant Therapies | Help Text: (S)
    2. Description: Study Medication (BIBF)
    3. Description: Adverse Event | Help Text: (S)
    4. Description: Termination of Period/Trial Medication | Help Text: (S)
    5. Description: Administration of BIBF Before | Help Text: (P) PKADM
    6. Description: Medication Compliance
    7. Description: Patient Eligibility | Help Text: (S)
  3. StudyEvent: TRT CHANGE
    1. Description: Study Medication (BIBF)
  4. StudyEvent: IVRS
    1. Description: Information from IVRS
  5. StudyEvent: VISIT 1
    1. Description: Patient Demographics | Help Text: (S)
    2. Description: Physical Examination (Screening) | Help Text: (P)
    3. Description: Concomitant Diagnosis / Baseline Conditions | Help Text: (S)
    4. Description: Six minutes walking test
    5. Description: Lab samples taken | Help Text: (O)
    6. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    7. Description: Pregnancy test | Help Text: (P)
    8. Description: ECG at screening | Help Text: (P)
    9. Description: Lab samples taken | Help Text: (O)
    10. Description: Lab Batch | Help Text: (O)
    11. Description: Pulmonary Function Testing | Help Text: (P)
    12. Description: Diagnosis of IPF
    13. Description: Inclusion/Exclusion Criteria | Help Text: (S)
    14. Description: Patient Eligibility | Help Text: (S)
    15. Description: Physical Examination ECOG score only | Help Text: (P)
    16. Description: Determination of DLco
    17. Description: Areterial Blood Gases
    18. Description: Concomitant Therapies | Help Text: (S)
    19. Description: Lab samples taken | Help Text: (O)
    20. Description: St. George's Respiratory Questionnaire | Help Text: (P)
    21. Description: Medical research council dyspnoea score
    22. Description: Physical Examination (except V3 V5) | Help Text: (P)
    23. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    24. Description: Substance measurement at time point | Help Text: (P)
    25. Description: Pharmacokinetic parameter PD | Help Text: (P)
  6. StudyEvent: VISIT 2
    1. Description: Diagnosis of IPF
    2. Description: Physical Examination (except V3 V5) | Help Text: (P)
    3. Description: St. George's Respiratory Questionnaire | Help Text: (P)
    4. Description: Medical research council dyspnoea score
    5. Description: Lab samples taken | Help Text: (O)
    6. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    7. Description: genetic informed conset
    8. Description: Pregnancy test | Help Text: (P)
    9. Description: Lab samples taken | Help Text: (O)
    10. Description: Pulmonary Function Testing | Help Text: (P)
    11. Description: Determination of DLco
    12. Description: Areterial Blood Gases
    13. Description: Six minutes walking test
    14. Description: Inclusion/Exclusion Criteria | Help Text: (S)
    15. Description: Patient Eligibility | Help Text: (S)
    16. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    17. Description: Administration of BIBF now (not used) | Help Text: (P) PKADM
    18. Description: Lab Batch | Help Text: (O)
    19. Description: Pulmonary Function Testing | Help Text: (P)
    20. Description: Administration of BIBF now | Help Text: (P) PKADM
    21. Description: Concomitant Therapies | Help Text: (S)
    22. Description: Assigned Medication Number(s) from Label(s)
    23. Description: Assigned Medication Number(s) from Label(s)
    24. Description: Substance measurement at time point | Help Text: (P)
    25. Description: Pharmacokinetic parameter | Help Text: (P)
    26. Description: Pharmacokinetic parameter PD | Help Text: (P)
  7. StudyEvent: VISIT 3
    1. Description: Medication Compliance
    2. Description: Physical Examination ECOG score only | Help Text: (P)
    3. Description: ECG | Help Text: (P)
    4. Description: Lab samples taken | Help Text: (O)
    5. Description: Lab samples taken | Help Text: (O)
    6. Description: Pulmonary Function Testing | Help Text: (P)
    7. Description: Lab Batch | Help Text: (O)
    8. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    9. Description: Substance measurement at time point | Help Text: (P)
  8. StudyEvent: VISIT 4
    1. Description: Medication Compliance
    2. Description: Administration of BIBF Before (not used) | Help Text: (P) PKADM
    3. Description: Physical Examination (except V3 V5) | Help Text: (P)
    4. Description: ECG | Help Text: (P)
    5. Description: Lab samples taken | Help Text: (O)
    6. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    7. Description: Lab samples taken | Help Text: (O)
    8. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    9. Description: Assigned Medication Number(s) from Label(s)
    10. Description: Lab Batch | Help Text: (O)
    11. Description: Administration of BIBF now (not used) | Help Text: (P) PKADM
    12. Description: Pulmonary Function Testing | Help Text: (P)
    13. Description: Administration of BIBF Before | Help Text: (P) PKADM
    14. Description: Administration of BIBF now | Help Text: (P) PKADM
    15. Description: genetic informed conset
    16. Description: Substance measurement at time point | Help Text: (P)
    17. Description: Pharmacokinetic parameter | Help Text: (P)
    18. Description: Pharmacokinetic parameter PD | Help Text: (P)
  9. StudyEvent: VISIT 5
    1. Description: Medication Compliance
    2. Description: Physical Examination ECOG score only | Help Text: (P)
    3. Description: Lab samples taken | Help Text: (O)
    4. Description: Lab samples taken | Help Text: (O)
    5. Description: Lab Batch | Help Text: (O)
    6. Description: Pulmonary Function Testing | Help Text: (P)
    7. Description: Administration of BIBF now | Help Text: (P) PKADM
    8. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    9. Description: Administration of BIBF Before | Help Text: (P) PKADM
    10. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    11. Description: Substance measurement at time point | Help Text: (P)
  10. StudyEvent: VISIT 6
    1. Description: Medication Compliance
    2. Description: Physical Examination (except V3 V5) | Help Text: (P)
    3. Description: St. George's Respiratory Questionnaire | Help Text: (P)
    4. Description: Medical research council dyspnoea score
    5. Description: ECG | Help Text: (P)
    6. Description: Lab samples taken | Help Text: (O)
    7. Description: Pregnancy test | Help Text: (P)
    8. Description: Lab samples taken | Help Text: (O)
    9. Description: Assigned Medication Number(s) from Label(s)
    10. Description: Lab Batch | Help Text: (O)
    11. Description: Pulmonary Function Testing | Help Text: (P)
    12. Description: Adverse Event | Help Text: (S)
    13. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    14. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    15. Description: Administration of BIBF now | Help Text: (P) PKADM
    16. Description: Substance measurement at time point | Help Text: (P)
  11. StudyEvent: VISIT 6A
    1. Description: Lab samples taken | Help Text: (O)
    2. Description: Lab Batch | Help Text: (O)
    3. Description: Six minutes walking test
    4. Description: Areterial Blood Gases
    5. Description: Pulmonary Function Testing | Help Text: (P)
    6. Description: Determination of DLco
    7. Description: Pulmonary Function Testing | Help Text: (P)
  12. StudyEvent: VISIT 7
    1. Description: Medication Compliance
    2. Description: Administration of BIBF Before | Help Text: (P) PKADM
    3. Description: Physical Examination (except V3 V5) | Help Text: (P)
    4. Description: St. George's Respiratory Questionnaire | Help Text: (P)
    5. Description: Medical research council dyspnoea score
    6. Description: ECG | Help Text: (P)
    7. Description: Lab samples taken | Help Text: (O)
    8. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    9. Description: Pregnancy test | Help Text: (P)
    10. Description: Lab samples taken | Help Text: (O)
    11. Description: Pulmonary Function Testing | Help Text: (P)
    12. Description: Six minutes walking test
    13. Description: Determination of DLco
    14. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    15. Description: Administration of BIBF now | Help Text: (P) PKADM
    16. Description: Assigned Medication Number(s) from Label(s)
    17. Description: Lab Batch | Help Text: (O)
    18. Description: Pulmonary Function Testing | Help Text: (P)
    19. Description: Areterial Blood Gases
    20. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    21. Description: Substance measurement at time point | Help Text: (P)
    22. Description: Pharmacokinetic parameter | Help Text: (P)
    23. Description: Pharmacokinetic parameter PD | Help Text: (P)
  13. StudyEvent: VISIT 7A
    1. Description: Lab samples taken | Help Text: (O)
    2. Description: Lab Batch | Help Text: (O)
    3. Description: Six minutes walking test
    4. Description: Pulmonary Function Testing | Help Text: (P)
    5. Description: Determination of DLco
  14. StudyEvent: VISIT 8
    1. Description: Medication Compliance
    2. Description: Physical Examination (except V3 V5) | Help Text: (P)
    3. Description: ECG | Help Text: (P)
    4. Description: Lab samples taken | Help Text: (O)
    5. Description: Pregnancy test | Help Text: (P)
    6. Description: Lab samples taken | Help Text: (O)
    7. Description: Assigned Medication Number(s) from Label(s)
    8. Description: Lab Batch | Help Text: (O)
    9. Description: Pulmonary Function Testing | Help Text: (P)
    10. Description: Determination of DLco
    11. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    12. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    13. Description: Substance measurement at time point | Help Text: (P)
  15. StudyEvent: VISIT 8A
    1. Description: Lab Batch | Help Text: (O)
    2. Description: Lab samples taken | Help Text: (O)
    3. Description: Physical Examination ECOG score only | Help Text: (P)
    4. Description: Pulmonary Function Testing | Help Text: (P)
  16. StudyEvent: VISIT 9
    1. Description: Medication Compliance
    2. Description: Administration of BIBF Before | Help Text: (P) PKADM
    3. Description: Physical Examination (except V3 V5) | Help Text: (P)
    4. Description: St. George's Respiratory Questionnaire | Help Text: (P)
    5. Description: Medical research council dyspnoea score
    6. Description: Lab samples taken | Help Text: (O)
    7. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    8. Description: Pregnancy test | Help Text: (P)
    9. Description: Lab samples taken | Help Text: (O)
    10. Description: Pulmonary Function Testing | Help Text: (P)
    11. Description: Six minutes walking test
    12. Description: Determination of DLco
    13. Description: Areterial Blood Gases
    14. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    15. Description: Administration of BIBF now | Help Text: (P) PKADM
    16. Description: Lab Batch | Help Text: (O)
    17. Description: Pulmonary Function Testing | Help Text: (P)
    18. Description: ECG | Help Text: (P)
    19. Description: Substance measurement at time point | Help Text: (P)
    20. Description: Pharmacokinetic parameter | Help Text: (P)
    21. Description: Pharmacokinetic parameter PD | Help Text: (P)
  17. StudyEvent: END TRT 1
    1. Description: Termination of Period/Trial Medication | Help Text: (S)
    2. Description: Assigned Medication Number(s) from Label(s)
    3. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
  18. StudyEvent: VISIT 10
    1. Description: Administration of BIBF Before | Help Text: (P) PKADM
    2. Description: Medication Compliance
    3. Description: Physical Examination (except V3 V5) | Help Text: (P)
    4. Description: ECG | Help Text: (P)
    5. Description: Lab samples taken | Help Text: (O)
    6. Description: Pregnancy test | Help Text: (P)
    7. Description: Lab samples taken | Help Text: (O)
    8. Description: Lab Batch | Help Text: (O)
    9. Description: Pulmonary Function Testing | Help Text: (P)
    10. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    11. Description: Substance measurement at time point | Help Text: (P)
  19. StudyEvent: VISIT 11
    1. Description: Medication Compliance
    2. Description: Physical Examination (except V3 V5) | Help Text: (P)
    3. Description: ECG | Help Text: (P)
    4. Description: Lab samples taken | Help Text: (O)
    5. Description: Pregnancy test | Help Text: (P)
    6. Description: Lab samples taken | Help Text: (O)
    7. Description: Assigned Medication Number(s) from Label(s)
    8. Description: Pulmonary Function Testing | Help Text: (P)
    9. Description: Lab Batch | Help Text: (O)
    10. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    11. Description: Substance measurement at time point | Help Text: (P)
  20. StudyEvent: VISIT 12
    1. Description: Medication Compliance
    2. Description: Physical Examination (except V3 V5) | Help Text: (P)
    3. Description: ECG | Help Text: (P)
    4. Description: Lab samples taken | Help Text: (O)
    5. Description: Pregnancy test | Help Text: (P)
    6. Description: Lab samples taken | Help Text: (O)
    7. Description: Assigned Medication Number(s) from Label(s)
    8. Description: Pulmonary Function Testing | Help Text: (P)
    9. Description: Lab Batch | Help Text: (O)
    10. Description: Pulmonary Function Testing | Help Text: (P)
    11. Description: Areterial Blood Gases
    12. Description: Determination of DLco
    13. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    14. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    15. Description: Substance measurement at time point | Help Text: (P)
  21. StudyEvent: VISIT 12A
    1. Description: Lab Batch | Help Text: (O)
    2. Description: Lab samples taken | Help Text: (O)
    3. Description: ECG | Help Text: (P)
    4. Description: Lab samples taken | Help Text: (O)
    5. Description: Pulmonary Function Testing | Help Text: (P)
  22. StudyEvent: VISIT 13
    1. Description: Medication Compliance
    2. Description: Physical Examination (except V3 V5) | Help Text: (P)
    3. Description: ECG | Help Text: (P)
    4. Description: Lab samples taken | Help Text: (O)
    5. Description: Pregnancy test | Help Text: (P)
    6. Description: Lab samples taken | Help Text: (O)
    7. Description: Determination of DLco
    8. Description: Assigned Medication Number(s) from Label(s)
    9. Description: Pulmonary Function Testing | Help Text: (P)
    10. Description: Lab Batch | Help Text: (O)
    11. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    12. Description: Substance measurement at time point | Help Text: (P)
  23. StudyEvent: VISIT 13A
    1. Description: Lab samples taken | Help Text: (O)
    2. Description: Lab Batch | Help Text: (O)
    3. Description: ECG | Help Text: (P)
  24. StudyEvent: VISIT 13B
    1. Description: Lab samples taken | Help Text: (O)
    2. Description: Lab Batch | Help Text: (O)
  25. StudyEvent: VISIT 13C
    1. Description: Lab Batch | Help Text: (O)
    2. Description: Lab samples taken | Help Text: (O)
    3. Description: Concomitant Therapies | Help Text: (S)
    4. Description: Physical Examination ECOG score only | Help Text: (P)
  26. StudyEvent: VISIT 14
    1. Description: Medication Compliance
    2. Description: Physical Examination (except V3 V5) | Help Text: (P)
    3. Description: ECG | Help Text: (P)
    4. Description: Lab samples taken | Help Text: (O)
    5. Description: Pregnancy test | Help Text: (P)
    6. Description: Lab samples taken | Help Text: (O)
    7. Description: Determination of DLco
    8. Description: Assigned Medication Number(s) from Label(s)
    9. Description: Pulmonary Function Testing | Help Text: (P)
    10. Description: Lab Batch | Help Text: (O)
  27. StudyEvent: VISIT 14A
    1. Description: Lab samples taken | Help Text: (O)
    2. Description: Lab Batch | Help Text: (O)
  28. StudyEvent: VISIT 14B
    1. Description: Lab samples taken | Help Text: (O)
    2. Description: Lab Batch | Help Text: (O)
    3. Description: Pulmonary Function Testing | Help Text: (P)
  29. StudyEvent: VISIT 14C
    1. Description: Lab samples taken | Help Text: (O)
    2. Description: Lab Batch | Help Text: (O)
  30. StudyEvent: VISIT 15
    1. Description: Medication Compliance
    2. Description: Physical Examination (except V3 V5) | Help Text: (P)
    3. Description: ECG | Help Text: (P)
    4. Description: Lab samples taken | Help Text: (O)
    5. Description: Pregnancy test | Help Text: (P)
    6. Description: Lab samples taken | Help Text: (O)
    7. Description: Determination of DLco
    8. Description: Assigned Medication Number(s) from Label(s)
    9. Description: Lab Batch | Help Text: (O)
    10. Description: Pulmonary Function Testing | Help Text: (P)
  31. StudyEvent: VISIT 15A
    1. Description: Lab Batch | Help Text: (O)
    2. Description: Lab samples taken | Help Text: (O)
  32. StudyEvent: VISIT 15B
    1. Description: Lab samples taken | Help Text: (O)
    2. Description: Lab Batch | Help Text: (O)
  33. StudyEvent: VISIT 15C
    1. Description: Lab samples taken | Help Text: (O)
    2. Description: Lab Batch | Help Text: (O)
  34. StudyEvent: VISIT 16
    1. Description: Medication Compliance
    2. Description: Physical Examination (except V3 V5) | Help Text: (P)
    3. Description: ECG | Help Text: (P)
    4. Description: Lab samples taken | Help Text: (O)
    5. Description: Pregnancy test | Help Text: (P)
    6. Description: Lab samples taken | Help Text: (O)
    7. Description: Determination of DLco
    8. Description: Assigned Medication Number(s) from Label(s)
    9. Description: Pulmonary Function Testing | Help Text: (P)
    10. Description: Lab Batch | Help Text: (O)
  35. StudyEvent: VISIT 16A
    1. Description: Lab samples taken | Help Text: (O)
    2. Description: Lab Batch | Help Text: (O)
  36. StudyEvent: VISIT 16B
    1. Description: Lab samples taken | Help Text: (O)
    2. Description: Lab Batch | Help Text: (O)
  37. StudyEvent: VISIT 16C
    1. Description: Lab samples taken | Help Text: (O)
    2. Description: Lab Batch | Help Text: (O)
  38. StudyEvent: END TRT 2
    1. Description: Termination of Period/Trial Medication | Help Text: (S)
    2. Description: Patient Vital Status | Help Text: (O)
  39. StudyEvent: EOT
    1. Description: Medication Compliance
    2. Description: Physical Examination (except V3 V5) | Help Text: (P)
    3. Description: ECG | Help Text: (P)
    4. Description: Lab samples taken | Help Text: (O)
    5. Description: Pregnancy test | Help Text: (P)
    6. Description: Lab samples taken | Help Text: (O)
    7. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    8. Description: Lab Batch | Help Text: (O)
    9. Description: Pulmonary Function Testing | Help Text: (P)
    10. Description: St. George's Respiratory Questionnaire | Help Text: (P)
    11. Description: Medical research council dyspnoea score
    12. Description: PK Blood Sampling (PTM=-0:05) | Help Text: (P) PKBLD
    13. Description: Pulmonary Function Testing | Help Text: (P)
    14. Description: Six minutes walking test
    15. Description: Determination of DLco
    16. Description: Areterial Blood Gases
    17. Description: Substance measurement at time point | Help Text: (P)
  40. StudyEvent: FOLLOWUP
    1. Description: Physical Examination (except V3 V5) | Help Text: (P)
    2. Description: Patient Vital Status | Help Text: (O)
    3. Description: Lab samples taken | Help Text: (O)
  41. StudyEvent: DISC V4
    1. Description: Physical Examination ECOG score only | Help Text: (P)
    2. Description: Lab samples taken | Help Text: (O)
    3. Description: Pulmonary Function Testing | Help Text: (P)
  42. StudyEvent: DISC V5
    1. Description: Physical Examination ECOG score only | Help Text: (P)
    2. Description: Lab samples taken | Help Text: (O)
    3. Description: Pulmonary Function Testing | Help Text: (P)
  43. StudyEvent: DISC V6
    1. Description: Physical Examination ECOG score only | Help Text: (P)
    2. Description: Lab samples taken | Help Text: (O)
    3. Description: Pulmonary Function Testing | Help Text: (P)
  44. StudyEvent: DISC V7
    1. Description: Physical Examination ECOG score only | Help Text: (P)
    2. Description: Lab samples taken | Help Text: (O)
    3. Description: Pulmonary Function Testing | Help Text: (P)
  45. StudyEvent: DISC V8
    1. Description: Physical Examination ECOG score only | Help Text: (P)
    2. Description: Lab samples taken | Help Text: (O)
    3. Description: Pulmonary Function Testing | Help Text: (P)
    4. Description: Lab samples taken | Help Text: (O)
  46. StudyEvent: DISC V9
    1. Description: Physical Examination ECOG score only | Help Text: (P)
    2. Description: Lab samples taken | Help Text: (O)
    3. Description: Pulmonary Function Testing | Help Text: (P)
    4. Description: Pulmonary Function Testing | Help Text: (P)
  47. StudyEvent: COMPLETION
    1. Description: Trial Completion | Help Text: (O)
    2. Description: Patient Vital Status | Help Text: (O)
    3. Description: Physical Examination ECOG score only | Help Text: (P)
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
LOCKED
Item
Locked
text
C3244297 (UMLS CUI [1, 1])
LAB
Item
Lab and lab range subset
text
C0022877 (UMLS CUI [1, 1])
C1515021 (UMLS CUI [1, 2])
C1514721 (UMLS CUI [1,1])
QUALVAL
Item
Qualifying Value
text
C1514624 (UMLS CUI [1, 1])
C1522609 (UMLS CUI [1,1])
HEADCMT
Item
Header Comment
text
C0947611 (UMLS CUI [1, 1])
INV
Item
Investigator
text
C0035173 (UMLS CUI [1, 1])
SITE
Item
Site
text
C0205145 (UMLS CUI [1, 1])
SUBVISIT
Item
Subevent
text
C2983704 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
VISIT
Item
Clinical Planned Event
text
C0205210 (UMLS CUI [1, 1])
C0441471 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
BLANK
Item
Blank Flag
text
C1708067 (UMLS CUI [1, 1])
DCMDATE
Item
DCM Date
date
C1302413 (UMLS CUI [1, 1])
DOCNUM
Item
Document Number
text
C2986015 (UMLS CUI [1, 1])
PATIENT
Item
Patient
text
C0030705 (UMLS CUI [1, 1])
Item
Does the patient have any baseline conditions?
text
C1442488 (UMLS CUI [1, 1])
C0030705 (UMLS CUI [1,1])
C0478635 (UMLS CUI [1,2])
YNF-1
Code List
Does the patient have any baseline conditions?
CL Item
No (0)
C1298908 (UMLS CUI [1,1])
CL Item
Yes (1)
C1705108 (UMLS CUI [1,1])
CDMX
Item
Condition / Diagnosis
text
C0478635 (UMLS CUI [1, 1])
CDADDX
Item
Relevant Additional Information
text
C1546922 (UMLS CUI [1, 1])
CDLLT
Item
CDLLT
text
C3846158 (UMLS CUI [1,1])
CDLLTCD
Item
CDLLTCD
text
C3846158 (UMLS CUI [1,1])
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