Englisch

Description: Administration of BIBF Before | Help Text: (P) PKADM

352 Formulare  
  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)
ADM
Beschreibung

ADM

Locked
Beschreibung

LOCKED

Datentyp

text

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

LAB

Datentyp

text

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

QUALVAL

Datentyp

text

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

HEADCMT

Datentyp

text

Alias
UMLS CUI [1, 1]
C0947611
Investigator
Beschreibung

INV

Datentyp

text

Alias
UMLS CUI [1, 1]
C0035173
Site
Beschreibung

SITE

Datentyp

text

Alias
UMLS CUI [1, 1]
C0205145
Subevent
Beschreibung

SUBVISIT

Datentyp

text

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

VISIT

Datentyp

text

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

BLANK

Datentyp

text

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

DCMDATE

Datentyp

date

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

DOCNUM

Datentyp

text

Alias
UMLS CUI [1, 1]
C2986015
Patient
Beschreibung

PATIENT

Datentyp

text

Alias
UMLS CUI [1, 1]
C0030705
Planned time
Beschreibung

PTM

Datentyp

text

Alias
UMLS CUI [1, 1]
C0040223
UMLS CUI [1, 2]
C1301732
Date
Beschreibung

ADMDT

Datentyp

date

Alias
UMLS CUI [1, 1]
C1302413
Time
Beschreibung

ADMTM

Datentyp

partialTime

Alias
UMLS CUI [1, 1]
C0040223
Planned time numeric
Beschreibung

PTMN

Datentyp

float

Alias
UMLS CUI [1,1]
C1301732
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C2825553
Hours after first dose
Beschreibung

ADMHAFD

Datentyp

float

Alias
UMLS CUI [1,1]
C0439227
UMLS CUI [1,2]
C0231290
UMLS CUI [1,3]
C0205435
UMLS CUI [1,4]
C3469597
Planned nominal drug content in product
Beschreibung

DRGCONP

Datentyp

float

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0454264
UMLS CUI [1,3]
C1301732
Nominal drug content, unit
Beschreibung

DRGCONU

Datentyp

text

Alias
UMLS CUI [1,1]
C0454264
UMLS CUI [1,2]
C1519795
Planned administered dose at PTM
Beschreibung

ADMDP

Datentyp

float

Alias
UMLS CUI [1,1]
C3469597
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1301732
Actual administered dose at PTM
Beschreibung

ADMDA

Datentyp

float

Alias
UMLS CUI [1,1]
C4068538
Administered dose, unit
Beschreibung

ADMDAU

Datentyp

text

Alias
UMLS CUI [1,1]
C4068538
UMLS CUI [1,2]
C1519795
Single regimen code used for PK
Beschreibung

ADMREG

Datentyp

text

Alias
UMLS CUI [1, 1]
C0040808
UMLS CUI [1,1]
C0805701
Actual Treatment Start Date
Beschreibung

ATRSTDT1

Datentyp

date

Alias
UMLS CUI [1,1]
C3173309
Actual Treatment Start Time
Beschreibung

ATRSTTM1

Datentyp

partialTime

Alias
UMLS CUI [1, 1]
C0087111
UMLS CUI [1,1]
C1301880
Actual Treatment Code
Beschreibung

ATRCD1

Datentyp

text

Alias
UMLS CUI [1, 1]
C0087111
UMLS CUI [1,1]
C0805701
Actual Treatment Start Date
Beschreibung

ATRSTDT2

Datentyp

date

Alias
UMLS CUI [1,1]
C3173309
Actual Treatment Start Time
Beschreibung

ATRSTTM2

Datentyp

partialTime

Alias
UMLS CUI [1, 1]
C0087111
UMLS CUI [1,1]
C1301880
Actual Treatment Code
Beschreibung

ATRCD2

Datentyp

text

Alias
UMLS CUI [1, 1]
C0087111
UMLS CUI [1,1]
C0805701
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Ähnliche Modelle

Description: Administration of BIBF Before | Help Text: (P) PKADM

352 Formulare
  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)
Datentyp
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 [1,1])
C1514721 (UMLS CUI [1,2])
C1515021 (UMLS CUI [1,3])
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 [1,2])
C1301732 (UMLS CUI [1,3])
BLANK
Item
Blank Flag
text
C1708067 (UMLS CUI [1, 1])
DCMDATE
Item
DCM Date
date
C1302413 (UMLS CUI [1, 1])
DOCNUM
Item
Document Number
text
C2986015 (UMLS CUI [1, 1])
PATIENT
Item
Patient
text
C0030705 (UMLS CUI [1, 1])
PTM
Item
Planned time
text
C0040223 (UMLS CUI [1, 1])
C1301732 (UMLS CUI [1, 2])
ADMDT
Item
Date
date
C1302413 (UMLS CUI [1, 1])
ADMTM
Item
Time
partialTime
C0040223 (UMLS CUI [1, 1])
PTMN
Item
Planned time numeric
float
C1301732 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C2825553 (UMLS CUI [1,3])
ADMHAFD
Item
Hours after first dose
float
C0439227 (UMLS CUI [1,1])
C0231290 (UMLS CUI [1,2])
C0205435 (UMLS CUI [1,3])
C3469597 (UMLS CUI [1,4])
DRGCONP
Item
Planned nominal drug content in product
float
C0013227 (UMLS CUI [1,1])
C0454264 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Item
Nominal drug content, unit
text
C0454264 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
UNITF-10
Code List
Nominal drug content, unit
CL Item
No unit (0)
CL Item
day (4)
CL Item
hr (5)
CL Item
min (6)
CL Item
s (7)
CL Item
ms (8)
CL Item
kg (23)
CL Item
g (24)
CL Item
mg (25)
CL Item
ug (26)
CL Item
ng (27)
CL Item
pg (28)
CL Item
mL/min/(m^2) (32)
CL Item
hr*uIU/mL (33)
CL Item
dL*mL/(mg*µIU) (36)
CL Item
dL*mL/(mg*ng) (37)
CL Item
mm (44)
CL Item
hr*hr*nmol/L (46)
CL Item
fmol/mL (48)
CL Item
cL (59)
CL Item
dL (60)
CL Item
L (64)
CL Item
mL (65)
CL Item
uL (66)
CL Item
nL (67)
CL Item
fL (69)
CL Item
/nL (71)
CL Item
/uL (72)
CL Item
10^3/uL (76)
CL Item
mmHg (81)
CL Item
nmol/10^9 (98)
CL Item
mol (119)
CL Item
mmol (120)
CL Item
umol (121)
CL Item
nmol (122)
CL Item
pmol (123)
CL Item
ug/mL/mg (134)
CL Item
umol/L/mg (136)
CL Item
ug/mL/kg (138)
CL Item
hr*ug/mL/kg (139)
CL Item
1/10^3 (199)
CL Item
% (200)
CL Item
1/hr (202)
CL Item
IU (206)
CL Item
mg/m^2 (210)
CL Item
ug/puff (214)
CL Item
pg/mg (215)
CL Item
mcg/puff (217)
CL Item
area unit (219)
CL Item
titer (223)
CL Item
pmol/L (224)
CL Item
IU/mL (227)
CL Item
ug/L (228)
CL Item
ng/L (229)
CL Item
ug/mL (230)
CL Item
g/dL (231)
CL Item
mg/dL (232)
CL Item
U/L (233)
CL Item
ug/dL (234)
CL Item
uU/mL (236)
CL Item
g/L (237)
CL Item
mIU/mL (238)
CL Item
ng/mL (240)
CL Item
pg/mL (242)
CL Item
U/mL (243)
CL Item
mg/L (244)
CL Item
mU/L (246)
CL Item
mg/mL (248)
CL Item
mg/g (249)
CL Item
mg/L/mg (263)
CL Item
ng/g (264)
CL Item
1/min (281)
CL Item
mL/min (283)
CL Item
L/min (288)
CL Item
L/kg (294)
CL Item
s*hr (295)
CL Item
L/hr/m^2 (296)
CL Item
mIU/L (297)
CL Item
hr*mIU/L (298)
CL Item
mEq/L (300)
CL Item
mmol/L (301)
CL Item
umol/L (302)
CL Item
nmol/L (305)
CL Item
nmol/mL (307)
CL Item
mmol/mL (308)
CL Item
umol/mL (309)
CL Item
pmol/mL (310)
CL Item
nmoleq/L (314)
CL Item
nmoleq/kg (315)
CL Item
pmol/L/ug (317)
CL Item
hr*pmol/L (318)
CL Item
hr*pmol/L/ug (319)
CL Item
pmoleq/L (321)
CL Item
pmoleq/kg (322)
CL Item
pmoleq (323)
CL Item
hr*pmoleq/L (324)
CL Item
hr*pmoleq/L/ug (325)
CL Item
pmoleq/L/ug (326)
CL Item
hr*pmol (327)
CL Item
hr*pmol/mg (328)
CL Item
pmol/mg (329)
CL Item
pmol/mL/mg (330)
CL Item
hr*uU/mL (331)
CL Item
nmol/g (332)
CL Item
10^6/uL (361)
CL Item
hr*ng/mL/mg (364)
CL Item
hr*ng/mL (365)
CL Item
hr*ug/mL (366)
CL Item
ng/mL/mg (377)
CL Item
molecules/cell (389)
CL Item
ng/mL/g (390)
CL Item
hr*umol/L/umol (410)
CL Item
mg/kg (420)
CL Item
hr*mmol/mL (422)
CL Item
hr*umol/mL (423)
CL Item
hr*nmol/mL (424)
CL Item
hr*pmol/mL (425)
CL Item
hr*IU/mL (426)
CL Item
hr*hr*mg/mL (427)
CL Item
hr*hr*ug/mL (428)
CL Item
hr*hr*ng/mL (429)
CL Item
hr*hr*pg/mL (430)
CL Item
hr*hr*mmol/mL (431)
CL Item
hr*hr*umol/mL (432)
CL Item
hr*hr*nmol/mL (433)
CL Item
hr*hr*pmol/mL (434)
CL Item
hr*hr*IU/mL (435)
CL Item
hr*mg/mL (436)
CL Item
1/day (437)
CL Item
hr*pg/mL/ug (438)
CL Item
pg/mL/ug (439)
CL Item
hr*pg/mL/ug*kg (440)
CL Item
mL/min/kg (441)
CL Item
hr*nmol/L (442)
CL Item
hr*ug/L (443)
CL Item
hr*ng*eq/mL (444)
CL Item
hr*ng*eq/mL/mg (445)
CL Item
ng*eq/mL/mg (446)
CL Item
ug*eq (447)
CL Item
ugeq (448)
CL Item
mL/hr (452)
CL Item
mg/hr (453)
CL Item
nmol/hr (454)
CL Item
hr*nmol/L/umol (455)
CL Item
nmol/L/umol (456)
CL Item
nmol/L/mg (458)
CL Item
hr*nmol/L/mg (459)
CL Item
ug/g UCRE (467)
CL Item
MBq (472)
CL Item
ng*eq/mL (475)
CL Item
MBq/mL (477)
CL Item
ng*eq/g (478)
CL Item
min*nmol/L (480)
CL Item
hr*pg/mL/mg (481)
CL Item
pg/mL/mg (482)
CL Item
O.D. (488)
CL Item
pg/mg Creatinine (490)
CL Item
cells/mm (491)
CL Item
L/hr/kg (494)
CL Item
cells/mL (492)
CL Item
hr*mg/dL (496)
CL Item
hr*mg/L (499)
CL Item
hr*mg/L/mg (500)
CL Item
hr*pg/mL/ug/kg (501)
CL Item
pg/mL/ug/kg (502)
CL Item
hr*nmol/L/nmol (503)
CL Item
nmol/L/nmol (504)
CL Item
hr*nmol/mg (505)
CL Item
hr*pmol/mL/mg (506)
CL Item
pg/mL/ug*kg (508)
CL Item
hr*ug/dL (509)
CL Item
hr*cells/nL (510)
CL Item
nmol/mL/mg (511)
CL Item
hr*10^6 cells (512)
CL Item
ng/mg of creatinine (735)
CL Item
copies/mL (755)
CL Item
L/hr (779)
CL Item
hr*pg/mL (780)
CL Item
cells/uL (783)
CL Item
ng/mL*kg (800)
CL Item
ng/mL/mg*kg (801)
CL Item
hr*ng/mL*kg (802)
CL Item
hr*ng/mL/mg*kg (803)
CL Item
RFU (804)
CL Item
% inhibition (805)
CL Item
hr*umol (806)
CL Item
hr*% (808)
CL Item
hr*cells/uL (809)
CL Item
hr*ug/mL/mg (810)
CL Item
hr*umol/mg (811)
CL Item
cells/nL (813)
CL Item
uIU/mL (814)
CL Item
nmolBCE/L (815)
CL Item
nmolBCE/mmolCr (816)
CL Item
pg/hr (817)
CL Item
hr*umol/L/mg (818)
CL Item
hr*umol/L (819)
CL Item
ngeq/mL (820)
CL Item
ngeq/g (821)
CL Item
hr*ngeq/mL (826)
CL Item
ngeq/mL/mg (829)
CL Item
hr*ngeq/mL/mg (830)
CL Item
hr*nmoleq/L/mg (831)
CL Item
hr*nmoleq/L (832)
CL Item
nmoleq/L/mg (833)
CL Item
nmoleq (834)
CL Item
hr*m^2/L (835)
CL Item
L/hr*m^2 (836)
CL Item
L/m^2 (837)
CL Item
hr*ng/mL/mg/m^2 (838)
CL Item
ng/mL/mg/m^2 (839)
CL Item
%*hr (840)
CL Item
mcg/actuation (841)
CL Item
nmol/kg (842)
CL Item
pmol/L/ug*kg (843)
CL Item
hr*pmol/L/ug*kg (844)
CL Item
hr*nmol/L*kg (845)
CL Item
nmol/L*kg (846)
CL Item
% Aggregation/min (848)
CL Item
mgeq (849)
CL Item
x10^6 cells (850)
CL Item
log10(IU/mL) (851)
CL Item
hr*log10(IU/mL) (852)
CL Item
mmol/mol (853)
CL Item
MFU (854)
CL Item
cells (855)
CL Item
U/mL (856)
CL Item
ng/dL (857)
CL Item
uCi/mg (859)
CL Item
mL/hr/kg (860)
CL Item
uEq/L (861)
CL Item
hr*MFU (862)
CL Item
uCi/g (863)
CL Item
uCi (864)
CL Item
ngeq (865)
CL Item
hr*U/L (866)
CL Item
pg/uL (867)
CL Item
Ru counts (868)
CL Item
O.D.*s (870)
CL Item
ECL counts (874)
CL Item
mL/kg (875)
CL Item
Up473/mL (878)
CL Item
L/day (879)
CL Item
day*ug/mL (880)
CL Item
day*ug/mL/mg (881)
CL Item
hr*mm (882)
CL Item
CTC/7.5 mL (883)
CL Item
Absorbance units (885)
CL Item
hr*ug/hr (890)
CL Item
fmol/mg (891)
ADMDP
Item
Planned administered dose at PTM
float
C3469597 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
ADMDA
Item
Actual administered dose at PTM
float
C4068538 (UMLS CUI [1,1])
Item
Administered dose, unit
text
C4068538 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
UNITF-10
Code List
Administered dose, unit
CL Item
No unit (0)
CL Item
day (4)
CL Item
hr (5)
CL Item
min (6)
CL Item
s (7)
CL Item
ms (8)
CL Item
kg (23)
CL Item
g (24)
CL Item
mg (25)
CL Item
ug (26)
CL Item
ng (27)
CL Item
pg (28)
CL Item
mL/min/(m^2) (32)
CL Item
hr*uIU/mL (33)
CL Item
dL*mL/(mg*µIU) (36)
CL Item
dL*mL/(mg*ng) (37)
CL Item
mm (44)
CL Item
hr*hr*nmol/L (46)
CL Item
fmol/mL (48)
CL Item
cL (59)
CL Item
dL (60)
CL Item
L (64)
CL Item
mL (65)
CL Item
uL (66)
CL Item
nL (67)
CL Item
fL (69)
CL Item
/nL (71)
CL Item
/uL (72)
CL Item
10^3/uL (76)
CL Item
mmHg (81)
CL Item
nmol/10^9 (98)
CL Item
mol (119)
CL Item
mmol (120)
CL Item
umol (121)
CL Item
nmol (122)
CL Item
pmol (123)
CL Item
ug/mL/mg (134)
CL Item
umol/L/mg (136)
CL Item
ug/mL/kg (138)
CL Item
hr*ug/mL/kg (139)
CL Item
1/10^3 (199)
CL Item
% (200)
CL Item
1/hr (202)
CL Item
IU (206)
CL Item
mg/m^2 (210)
CL Item
ug/puff (214)
CL Item
pg/mg (215)
CL Item
mcg/puff (217)
CL Item
area unit (219)
CL Item
titer (223)
CL Item
pmol/L (224)
CL Item
IU/mL (227)
CL Item
ug/L (228)
CL Item
ng/L (229)
CL Item
ug/mL (230)
CL Item
g/dL (231)
CL Item
mg/dL (232)
CL Item
U/L (233)
CL Item
ug/dL (234)
CL Item
uU/mL (236)
CL Item
g/L (237)
CL Item
mIU/mL (238)
CL Item
ng/mL (240)
CL Item
pg/mL (242)
CL Item
U/mL (243)
CL Item
mg/L (244)
CL Item
mU/L (246)
CL Item
mg/mL (248)
CL Item
mg/g (249)
CL Item
mg/L/mg (263)
CL Item
ng/g (264)
CL Item
1/min (281)
CL Item
mL/min (283)
CL Item
L/min (288)
CL Item
L/kg (294)
CL Item
s*hr (295)
CL Item
L/hr/m^2 (296)
CL Item
mIU/L (297)
CL Item
hr*mIU/L (298)
CL Item
mEq/L (300)
CL Item
mmol/L (301)
CL Item
umol/L (302)
CL Item
nmol/L (305)
CL Item
nmol/mL (307)
CL Item
mmol/mL (308)
CL Item
umol/mL (309)
CL Item
pmol/mL (310)
CL Item
nmoleq/L (314)
CL Item
nmoleq/kg (315)
CL Item
pmol/L/ug (317)
CL Item
hr*pmol/L (318)
CL Item
hr*pmol/L/ug (319)
CL Item
pmoleq/L (321)
CL Item
pmoleq/kg (322)
CL Item
pmoleq (323)
CL Item
hr*pmoleq/L (324)
CL Item
hr*pmoleq/L/ug (325)
CL Item
pmoleq/L/ug (326)
CL Item
hr*pmol (327)
CL Item
hr*pmol/mg (328)
CL Item
pmol/mg (329)
CL Item
pmol/mL/mg (330)
CL Item
hr*uU/mL (331)
CL Item
nmol/g (332)
CL Item
10^6/uL (361)
CL Item
hr*ng/mL/mg (364)
CL Item
hr*ng/mL (365)
CL Item
hr*ug/mL (366)
CL Item
ng/mL/mg (377)
CL Item
molecules/cell (389)
CL Item
ng/mL/g (390)
CL Item
hr*umol/L/umol (410)
CL Item
mg/kg (420)
CL Item
hr*mmol/mL (422)
CL Item
hr*umol/mL (423)
CL Item
hr*nmol/mL (424)
CL Item
hr*pmol/mL (425)
CL Item
hr*IU/mL (426)
CL Item
hr*hr*mg/mL (427)
CL Item
hr*hr*ug/mL (428)
CL Item
hr*hr*ng/mL (429)
CL Item
hr*hr*pg/mL (430)
CL Item
hr*hr*mmol/mL (431)
CL Item
hr*hr*umol/mL (432)
CL Item
hr*hr*nmol/mL (433)
CL Item
hr*hr*pmol/mL (434)
CL Item
hr*hr*IU/mL (435)
CL Item
hr*mg/mL (436)
CL Item
1/day (437)
CL Item
hr*pg/mL/ug (438)
CL Item
pg/mL/ug (439)
CL Item
hr*pg/mL/ug*kg (440)
CL Item
mL/min/kg (441)
CL Item
hr*nmol/L (442)
CL Item
hr*ug/L (443)
CL Item
hr*ng*eq/mL (444)
CL Item
hr*ng*eq/mL/mg (445)
CL Item
ng*eq/mL/mg (446)
CL Item
ug*eq (447)
CL Item
ugeq (448)
CL Item
mL/hr (452)
CL Item
mg/hr (453)
CL Item
nmol/hr (454)
CL Item
hr*nmol/L/umol (455)
CL Item
nmol/L/umol (456)
CL Item
nmol/L/mg (458)
CL Item
hr*nmol/L/mg (459)
CL Item
ug/g UCRE (467)
CL Item
MBq (472)
CL Item
ng*eq/mL (475)
CL Item
MBq/mL (477)
CL Item
ng*eq/g (478)
CL Item
min*nmol/L (480)
CL Item
hr*pg/mL/mg (481)
CL Item
pg/mL/mg (482)
CL Item
O.D. (488)
CL Item
pg/mg Creatinine (490)
CL Item
cells/mm (491)
CL Item
L/hr/kg (494)
CL Item
cells/mL (492)
CL Item
hr*mg/dL (496)
CL Item
hr*mg/L (499)
CL Item
hr*mg/L/mg (500)
CL Item
hr*pg/mL/ug/kg (501)
CL Item
pg/mL/ug/kg (502)
CL Item
hr*nmol/L/nmol (503)
CL Item
nmol/L/nmol (504)
CL Item
hr*nmol/mg (505)
CL Item
hr*pmol/mL/mg (506)
CL Item
pg/mL/ug*kg (508)
CL Item
hr*ug/dL (509)
CL Item
hr*cells/nL (510)
CL Item
nmol/mL/mg (511)
CL Item
hr*10^6 cells (512)
CL Item
ng/mg of creatinine (735)
CL Item
copies/mL (755)
CL Item
L/hr (779)
CL Item
hr*pg/mL (780)
CL Item
cells/uL (783)
CL Item
ng/mL*kg (800)
CL Item
ng/mL/mg*kg (801)
CL Item
hr*ng/mL*kg (802)
CL Item
hr*ng/mL/mg*kg (803)
CL Item
RFU (804)
CL Item
% inhibition (805)
CL Item
hr*umol (806)
CL Item
hr*% (808)
CL Item
hr*cells/uL (809)
CL Item
hr*ug/mL/mg (810)
CL Item
hr*umol/mg (811)
CL Item
cells/nL (813)
CL Item
uIU/mL (814)
CL Item
nmolBCE/L (815)
CL Item
nmolBCE/mmolCr (816)
CL Item
pg/hr (817)
CL Item
hr*umol/L/mg (818)
CL Item
hr*umol/L (819)
CL Item
ngeq/mL (820)
CL Item
ngeq/g (821)
CL Item
hr*ngeq/mL (826)
CL Item
ngeq/mL/mg (829)
CL Item
hr*ngeq/mL/mg (830)
CL Item
hr*nmoleq/L/mg (831)
CL Item
hr*nmoleq/L (832)
CL Item
nmoleq/L/mg (833)
CL Item
nmoleq (834)
CL Item
hr*m^2/L (835)
CL Item
L/hr*m^2 (836)
CL Item
L/m^2 (837)
CL Item
hr*ng/mL/mg/m^2 (838)
CL Item
ng/mL/mg/m^2 (839)
CL Item
%*hr (840)
CL Item
mcg/actuation (841)
CL Item
nmol/kg (842)
CL Item
pmol/L/ug*kg (843)
CL Item
hr*pmol/L/ug*kg (844)
CL Item
hr*nmol/L*kg (845)
CL Item
nmol/L*kg (846)
CL Item
% Aggregation/min (848)
CL Item
mgeq (849)
CL Item
x10^6 cells (850)
CL Item
log10(IU/mL) (851)
CL Item
hr*log10(IU/mL) (852)
CL Item
mmol/mol (853)
CL Item
MFU (854)
CL Item
cells (855)
CL Item
U/mL (856)
CL Item
ng/dL (857)
CL Item
uCi/mg (859)
CL Item
mL/hr/kg (860)
CL Item
uEq/L (861)
CL Item
hr*MFU (862)
CL Item
uCi/g (863)
CL Item
uCi (864)
CL Item
ngeq (865)
CL Item
hr*U/L (866)
CL Item
pg/uL (867)
CL Item
Ru counts (868)
CL Item
O.D.*s (870)
CL Item
ECL counts (874)
CL Item
mL/kg (875)
CL Item
Up473/mL (878)
CL Item
L/day (879)
CL Item
day*ug/mL (880)
CL Item
day*ug/mL/mg (881)
CL Item
hr*mm (882)
CL Item
CTC/7.5 mL (883)
CL Item
Absorbance units (885)
CL Item
hr*ug/hr (890)
CL Item
fmol/mg (891)
ADMREG
Item
Single regimen code used for PK
text
C0040808 (UMLS CUI [1, 1])
C0805701 (UMLS CUI [1,1])
ATRSTDT1
Item
Actual Treatment Start Date
date
C3173309 (UMLS CUI [1,1])
ATRSTTM1
Item
Actual Treatment Start Time
partialTime
C0087111 (UMLS CUI [1, 1])
C1301880 (UMLS CUI [1,1])
ATRCD1
Item
Actual Treatment Code
text
C0087111 (UMLS CUI [1, 1])
C0805701 (UMLS CUI [1,1])
ATRSTDT2
Item
Actual Treatment Start Date
date
C3173309 (UMLS CUI [1,1])
ATRSTTM2
Item
Actual Treatment Start Time
partialTime
C0087111 (UMLS CUI [1, 1])
C1301880 (UMLS CUI [1,1])
ATRCD2
Item
Actual Treatment Code
text
C0087111 (UMLS CUI [1, 1])
C0805701 (UMLS CUI [1,1])
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