Description: Patient Eligibility | Help Text: (S)

352 Formulare

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
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)
StudyEvent: TRT CHANGE
1. Description: Study Medication (BIBF)
StudyEvent: IVRS
1. Description: Information from IVRS
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)
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)
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)
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)
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)
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)
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)
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)
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
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)
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)
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)
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
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)
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)
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)
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)
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)
StudyEvent: VISIT 13A
1. Description: Lab samples taken | Help Text: (O)
2. Description: Lab Batch | Help Text: (O)
3. Description: ECG | Help Text: (P)
StudyEvent: VISIT 13B
1. Description: Lab samples taken | Help Text: (O)
2. Description: Lab Batch | Help Text: (O)
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)
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)
StudyEvent: VISIT 14A
1. Description: Lab samples taken | Help Text: (O)
2. Description: Lab Batch | Help Text: (O)
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)
StudyEvent: VISIT 14C
1. Description: Lab samples taken | Help Text: (O)
2. Description: Lab Batch | Help Text: (O)
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)
StudyEvent: VISIT 15A
1. Description: Lab Batch | Help Text: (O)
2. Description: Lab samples taken | Help Text: (O)
StudyEvent: VISIT 15B
1. Description: Lab samples taken | Help Text: (O)
2. Description: Lab Batch | Help Text: (O)
StudyEvent: VISIT 15C
1. Description: Lab samples taken | Help Text: (O)
2. Description: Lab Batch | Help Text: (O)
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)
StudyEvent: VISIT 16A
1. Description: Lab samples taken | Help Text: (O)
2. Description: Lab Batch | Help Text: (O)
StudyEvent: VISIT 16B
1. Description: Lab samples taken | Help Text: (O)
2. Description: Lab Batch | Help Text: (O)
StudyEvent: VISIT 16C
1. Description: Lab samples taken | Help Text: (O)
2. Description: Lab Batch | Help Text: (O)
StudyEvent: END TRT 2
1. Description: Termination of Period/Trial Medication | Help Text: (S)
2. Description: Patient Vital Status | Help Text: (O)
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)
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)
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)
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)
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)
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)
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)
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)
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)

RAND

Beschreibung

RAND

Alias

UMLS CUI [1,1]: C0034656

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 [2,1]: C0022877

UMLS CUI [2,2]: C1514721

UMLS CUI [2,3]: 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 [1,1]: C0441471

UMLS CUI [1,2]: C1301732

Blank Flag

Beschreibung

BLANK

Datentyp

text

Alias

UMLS CUI [1, 1]: C1708067

DCM Date

Beschreibung

DCMDATE

Datentyp

date

Alias

UMLS CUI [1,1]: C0011008

Document Number

Beschreibung

DOCNUM

Datentyp

text

Alias

UMLS CUI [1, 1]: C2986015

Patient

Beschreibung

PATIENT

Datentyp

text

Alias

UMLS CUI [1, 1]: C0030705

Will the patient be assigned randomised treatment?

Beschreibung

RANDEL

Datentyp

text

Alias

UMLS CUI [1, 1]: C0030705

UMLS CUI [1,1]: C0034656

UMLS CUI [1,2]: C0087111

No (0)

Yes (1)

Date of randomisation

Beschreibung

RANDDT

Datentyp

date

Alias

UMLS CUI [1, 1]: C0011008

UMLS CUI [1,1]: C0034656

Medication number assigned

Beschreibung

RANDNO

Datentyp

text

Alias

UMLS CUI [1, 1]: C0013227

UMLS CUI [1,1]: C0237753

Actual Treatment Code

Beschreibung

ATRCD

Datentyp

text

Alias

UMLS CUI [1, 1]: C0087111

UMLS CUI [1,1]: C0805701

UMLS CUI [1,2]: C0237400

Actual Treatment Start Date

Beschreibung

ATRSTDT

Datentyp

date

Alias

UMLS CUI [1, 1]: C3173309

UMLS CUI [1,1]: C0237400

Actual Treatment Start Time

Beschreibung

ATRSTTM

Datentyp

partialTime

Alias

UMLS CUI [1, 1]: C0087111

UMLS CUI [1,1]: C1301880

UMLS CUI [1,2]: C0237400

ELIG

Beschreibung

ELIG

Alias

UMLS CUI [1,1]: C0013893

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 [2,1]: C0022877

UMLS CUI [2,2]: C1514721

UMLS CUI [2,3]: 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 [1,1]: C0441471

UMLS CUI [1,2]: 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

Primary reason for non-inclusion

Beschreibung

ELIG

Datentyp

text

Alias

UMLS CUI [1, 1]: C1549995

UMLS CUI [1,1]: C0332257

UMLS CUI [1,2]: C1272696

Eligibility comment

Beschreibung

ELIGX

Datentyp

text

Alias

UMLS CUI [1, 1]: C0947611

UMLS CUI [1,1]: C0013893

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Description: Patient Eligibility | Help Text: (S)

352 Formulare

Name

Typ

Description | Question | Decode (Coded Value)

Datentyp

Alias

RAND

Item Group

C0034656 (UMLS CUI [1,1])

LOCKED

Item

Locked

text

C3244297 (UMLS CUI [1, 1])

LAB

Item

Lab and lab range subset

text

C0022877 (UMLS CUI [1, 1])
C0022877 (UMLS CUI [2,1])
C1514721 (UMLS CUI [2,2])
C1515021 (UMLS CUI [2,3])

QUALVAL

Item

Qualifying Value

text

C1514624 (UMLS CUI [1, 1])
C1522609 (UMLS CUI [1,1])

HEADCMT

Item

Header Comment

text

C0947611 (UMLS CUI [1, 1])

INV

Item

Investigator

text

C0035173 (UMLS CUI [1, 1])

SITE

Item

Site

text

C0205145 (UMLS CUI [1, 1])

SUBVISIT

Item

Subevent

text

C2983704 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])

VISIT

Item

Clinical Planned Event

text

C0205210 (UMLS CUI [1, 1])
C0441471 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])

BLANK

Item

Blank Flag

text

C1708067 (UMLS CUI [1, 1])

DCMDATE

Item

DCM Date

date

C0011008 (UMLS CUI [1,1])

DOCNUM

Item

Document Number

text

C2986015 (UMLS CUI [1, 1])

PATIENT

Item

Patient

text

C0030705 (UMLS CUI [1, 1])

RANDEL

Item

Will the patient be assigned randomised treatment?

text

C0030705 (UMLS CUI [1, 1])
C0034656 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])

YNF-1

Code List

Will the patient be assigned randomised treatment?

CL Item

No (0)

C1298908 (UMLS CUI [1,1])

CL Item

Yes (1)

C1705108 (UMLS CUI [1,1])

RANDDT

Item

Date of randomisation

date

C0011008 (UMLS CUI [1, 1])
C0034656 (UMLS CUI [1,1])

RANDNO

Item

Medication number assigned

text

C0013227 (UMLS CUI [1, 1])
C0237753 (UMLS CUI [1,1])

ATRCD

Item

Actual Treatment Code

text

C0087111 (UMLS CUI [1, 1])
C0805701 (UMLS CUI [1,1])
C0237400 (UMLS CUI [1,2])

ATRSTDT

Item

Actual Treatment Start Date

date

C3173309 (UMLS CUI [1, 1])
C0237400 (UMLS CUI [1,1])

ATRSTTM

Item

Actual Treatment Start Time

partialTime

C0087111 (UMLS CUI [1, 1])
C1301880 (UMLS CUI [1,1])
C0237400 (UMLS CUI [1,2])

ELIG

Item Group

C0013893 (UMLS CUI [1,1])

LOCKED

Item

Locked

text

C3244297 (UMLS CUI [1, 1])

LAB

Item

Lab and lab range subset

text

C0022877 (UMLS CUI [1, 1])
C0022877 (UMLS CUI [2,1])
C1514721 (UMLS CUI [2,2])
C1515021 (UMLS CUI [2,3])

QUALVAL

Item

Qualifying Value

text

C1514624 (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])

ELIG

Item

Primary reason for non-inclusion

text

C1549995 (UMLS CUI [1, 1])
C0332257 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])

ELIGF-1

Code List

Primary reason for non-inclusion

CL Item

Adverse event (1)

C0877248 (UMLS CUI [1,1])

CL Item

In/ex criteria (2)

C2827031 (UMLS CUI [1,1])

CL Item

Lost to follow-up (3)

C1302313 (UMLS CUI [1,1])

CL Item

Consent withdrawn (4)

C1707492 (UMLS CUI [1,1])

CL Item

Other (5)

C0205394 (UMLS CUI [1,1])

ELIGX

Item

Eligibility comment

text

C0947611 (UMLS CUI [1, 1])
C0013893 (UMLS CUI [1,1])

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