Description: Inclusion/Exclusion Criteria | Help Text: (S)

352 forms

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)

Name

Type

Description | Question | Decode (Coded Value)

Data type

Alias

INCL

Item Group

C1512693 (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])
C1515021 (UMLS CUI [1,2])
C1514721 (UMLS CUI [1,3])

QUALVAL

Item

Qualifying Value

text

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

INEXQ

Item

No.

text

C3846158 (UMLS CUI [1,1])

INEXQF-1

Code List

No.

CL Item

IN1 (IN1)

CL Item

IN2 (IN2)

CL Item

IN3 (IN3)

CL Item

IN4 (IN4)

CL Item

IN5 (IN5)

CL Item

IN6 (IN6)

CL Item

IN7 (IN7)

CL Item

IN8 (IN8)

CL Item

IN9 (IN9)

CL Item

IN10 (IN10)

CL Item

IN11 (IN11)

CL Item

IN12 (IN12)

CL Item

IN13 (IN13)

CL Item

IN14 (IN14)

CL Item

IN15 (IN15)

CL Item

IN16 (IN16)

CL Item

IN17 (IN17)

CL Item

IN18 (IN18)

CL Item

IN19 (IN19)

CL Item

IN20 (IN20)

CL Item

IN21 (IN21)

CL Item

IN22 (IN22)

CL Item

IN23 (IN23)

CL Item

IN24 (IN24)

CL Item

IN25 (IN25)

CL Item

IN26 (IN26)

CL Item

IN27 (IN27)

CL Item

IN28 (IN28)

CL Item

IN29 (IN29)

CL Item

IN30 (IN30)

CL Item

IN31 (IN31)

CL Item

IN32 (IN32)

CL Item

IN33 (IN33)

CL Item

IN34 (IN34)

CL Item

IN35 (IN35)

CL Item

IN36 (IN36)

CL Item

IN37 (IN37)

CL Item

IN38 (IN38)

CL Item

IN39 (IN39)

CL Item

IN40 (IN40)

CL Item

IN41 (IN41)

CL Item

IN42 (IN42)

CL Item

IN43 (IN43)

CL Item

IN44 (IN44)

CL Item

IN45 (IN45)

CL Item

IN46 (IN46)

CL Item

IN47 (IN47)

CL Item

IN48 (IN48)

CL Item

IN49 (IN49)

CL Item

IN50 (IN50)

CL Item

IN51 (IN51)

CL Item

IN52 (IN52)

CL Item

IN53 (IN53)

CL Item

IN54 (IN54)

CL Item

IN55 (IN55)

CL Item

IN56 (IN56)

CL Item

IN57 (IN57)

CL Item

IN58 (IN58)

CL Item

IN59 (IN59)

CL Item

IN60 (IN60)

CL Item

IN61 (IN61)

CL Item

IN62 (IN62)

CL Item

IN63 (IN63)

CL Item

IN64 (IN64)

CL Item

IN80 (IN80)

CL Item

IN81 (IN81)

CL Item

IN82 (IN82)

CL Item

IN83 (IN83)

CL Item

IN84 (IN84)

CL Item

IN91 (IN91)

CL Item

IN92 (IN92)

CL Item

IN93 (IN93)

CL Item

IN151 (IN151)

CL Item

IN152 (IN152)

CL Item

IN153 (IN153)

CL Item

IN1A (IN1A)

CL Item

IN1B (IN1B)

CL Item

IN2A (IN2A)

CL Item

IN2B (IN2B)

CL Item

IN2C (IN2C)

CL Item

IN2D (IN2D)

CL Item

IN3A (IN3A)

CL Item

IN5A (IN5A)

CL Item

IN6A (IN6A)

CL Item

IN4A (IN4A)

CL Item

IN4B (IN4B)

CL Item

IN7A (IN7A)

CL Item

IN8A (IN8A)

CL Item

IN9A (IN9A)

CL Item

IN11A (IN11A)

CL Item

IN12A (IN12A)

CL Item

IN14A (IN14A)

CL Item

EX1 (EX1)

CL Item

EX2 (EX2)

CL Item

EX3 (EX3)

CL Item

EX4 (EX4)

CL Item

EX5 (EX5)

CL Item

EX6 (EX6)

CL Item

EX7 (EX7)

CL Item

EX8 (EX8)

CL Item

EX9 (EX9)

CL Item

EX10 (EX10)

CL Item

EX11 (EX11)

CL Item

EX12 (EX12)

CL Item

EX13 (EX13)

CL Item

EX14 (EX14)

CL Item

EX15 (EX15)

CL Item

EX16 (EX16)

CL Item

EX17 (EX17)

CL Item

EX18 (EX18)

CL Item

EX19 (EX19)

CL Item

EX20 (EX20)

CL Item

EX21 (EX21)

CL Item

EX22 (EX22)

CL Item

EX23 (EX23)

CL Item

EX24 (EX24)

CL Item

EX25 (EX25)

CL Item

EX26 (EX26)

CL Item

EX27 (EX27)

CL Item

EX28 (EX28)

CL Item

EX29 (EX29)

CL Item

EX30 (EX30)

CL Item

EX31 (EX31)

CL Item

EX32 (EX32)

CL Item

EX33 (EX33)

CL Item

EX34 (EX34)

CL Item

EX35 (EX35)

CL Item

EX36 (EX36)

CL Item

EX37 (EX37)

CL Item

EX38 (EX38)

CL Item

EX39 (EX39)

CL Item

EX40 (EX40)

CL Item

EX41 (EX41)

CL Item

EX42 (EX42)

CL Item

EX43 (EX43)

CL Item

EX44 (EX44)

CL Item

EX45 (EX45)

CL Item

EX46 (EX46)

CL Item

EX47 (EX47)

CL Item

EX48 (EX48)

CL Item

EX49 (EX49)

CL Item

EX50 (EX50)

CL Item

EX51 (EX51)

CL Item

EX52 (EX52)

CL Item

EX53 (EX53)

CL Item

EX54 (EX54)

CL Item

EX55 (EX55)

CL Item

EX56 (EX56)

CL Item

EX57 (EX57)

CL Item

EX58 (EX58)

CL Item

EX59 (EX59)

CL Item

EX60 (EX60)

CL Item

EX61 (EX61)

CL Item

EX62 (EX62)

CL Item

EX63 (EX63)

CL Item

EX64 (EX64)

CL Item

EX65 (EX65)

CL Item

EX66 (EX66)

CL Item

EX67 (EX67)

CL Item

EX1A (EX1A)

CL Item

EX4A (EX4A)

CL Item

EX3A (EX3A)

CL Item

EX5A (EX5A)

CL Item

EX6A (EX6A)

CL Item

EX7A (EX7A)

CL Item

EX8A (EX8A)

CL Item

EX9A (EX9A)

CL Item

EX10A (EX10A)

CL Item

EX13A (EX13A)

CL Item

EX15A (EX15A)

CL Item

EX16A (EX16A)

CL Item

EX17A (EX17A)

CL Item

EX18A (EX18A)

INEXC

Item

Inclusion criteria met

text

C1550543 (UMLS CUI [1, 1])
C1512693 (UMLS CUI [1,1])

YNF-1

Code List

Inclusion criteria met

CL Item

No (0)

C1298908 (UMLS CUI [1,1])

CL Item

Yes (1)

C1705108 (UMLS CUI [1,1])

INEXNM

Item

Inclusion criteria description

text

C0678257 (UMLS CUI [1, 1])

EXCL

Item Group

C0680251 (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])
C1515021 (UMLS CUI [1,2])
C1514721 (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])

INEXQ

Item

No.

text

C0237753 (UMLS CUI [1,1])

INEXQF-1

Code List

No.

CL Item

IN1 (IN1)

CL Item

IN2 (IN2)

CL Item

IN3 (IN3)

CL Item

IN4 (IN4)

CL Item

IN5 (IN5)

CL Item

IN6 (IN6)

CL Item

IN7 (IN7)

CL Item

IN8 (IN8)

CL Item

IN9 (IN9)

CL Item

IN10 (IN10)

CL Item

IN11 (IN11)

CL Item

IN12 (IN12)

CL Item

IN13 (IN13)

CL Item

IN14 (IN14)

CL Item

IN15 (IN15)

CL Item

IN16 (IN16)

CL Item

IN17 (IN17)

CL Item

IN18 (IN18)

CL Item

IN19 (IN19)

CL Item

IN20 (IN20)

CL Item

IN21 (IN21)

CL Item

IN22 (IN22)

CL Item

IN23 (IN23)

CL Item

IN24 (IN24)

CL Item

IN25 (IN25)

CL Item

IN26 (IN26)

CL Item

IN27 (IN27)

CL Item

IN28 (IN28)

CL Item

IN29 (IN29)

CL Item

IN30 (IN30)

CL Item

IN31 (IN31)

CL Item

IN32 (IN32)

CL Item

IN33 (IN33)

CL Item

IN34 (IN34)

CL Item

IN35 (IN35)

CL Item

IN36 (IN36)

CL Item

IN37 (IN37)

CL Item

IN38 (IN38)

CL Item

IN39 (IN39)

CL Item

IN40 (IN40)

CL Item

IN41 (IN41)

CL Item

IN42 (IN42)

CL Item

IN43 (IN43)

CL Item

IN44 (IN44)

CL Item

IN45 (IN45)

CL Item

IN46 (IN46)

CL Item

IN47 (IN47)

CL Item

IN48 (IN48)

CL Item

IN49 (IN49)

CL Item

IN50 (IN50)

CL Item

IN51 (IN51)

CL Item

IN52 (IN52)

CL Item

IN53 (IN53)

CL Item

IN54 (IN54)

CL Item

IN55 (IN55)

CL Item

IN56 (IN56)

CL Item

IN57 (IN57)

CL Item

IN58 (IN58)

CL Item

IN59 (IN59)

CL Item

IN60 (IN60)

CL Item

IN61 (IN61)

CL Item

IN62 (IN62)

CL Item

IN63 (IN63)

CL Item

IN64 (IN64)

CL Item

IN80 (IN80)

CL Item

IN81 (IN81)

CL Item

IN82 (IN82)

CL Item

IN83 (IN83)

CL Item

IN84 (IN84)

CL Item

IN91 (IN91)

CL Item

IN92 (IN92)

CL Item

IN93 (IN93)

CL Item

IN151 (IN151)

CL Item

IN152 (IN152)

CL Item

IN153 (IN153)

CL Item

IN1A (IN1A)

CL Item

IN1B (IN1B)

CL Item

IN2A (IN2A)

CL Item

IN2B (IN2B)

CL Item

IN2C (IN2C)

CL Item

IN2D (IN2D)

CL Item

IN3A (IN3A)

CL Item

IN5A (IN5A)

CL Item

IN6A (IN6A)

CL Item

IN4A (IN4A)

CL Item

IN4B (IN4B)

CL Item

IN7A (IN7A)

CL Item

IN8A (IN8A)

CL Item

IN9A (IN9A)

CL Item

IN11A (IN11A)

CL Item

IN12A (IN12A)

CL Item

IN14A (IN14A)

CL Item

EX1 (EX1)

CL Item

EX2 (EX2)

CL Item

EX3 (EX3)

CL Item

EX4 (EX4)

CL Item

EX5 (EX5)

CL Item

EX6 (EX6)

CL Item

EX7 (EX7)

CL Item

EX8 (EX8)

CL Item

EX9 (EX9)

CL Item

EX10 (EX10)

CL Item

EX11 (EX11)

CL Item

EX12 (EX12)

CL Item

EX13 (EX13)

CL Item

EX14 (EX14)

CL Item

EX15 (EX15)

CL Item

EX16 (EX16)

CL Item

EX17 (EX17)

CL Item

EX18 (EX18)

CL Item

EX19 (EX19)

CL Item

EX20 (EX20)

CL Item

EX21 (EX21)

CL Item

EX22 (EX22)

CL Item

EX23 (EX23)

CL Item

EX24 (EX24)

CL Item

EX25 (EX25)

CL Item

EX26 (EX26)

CL Item

EX27 (EX27)

CL Item

EX28 (EX28)

CL Item

EX29 (EX29)

CL Item

EX30 (EX30)

CL Item

EX31 (EX31)

CL Item

EX32 (EX32)

CL Item

EX33 (EX33)

CL Item

EX34 (EX34)

CL Item

EX35 (EX35)

CL Item

EX36 (EX36)

CL Item

EX37 (EX37)

CL Item

EX38 (EX38)

CL Item

EX39 (EX39)

CL Item

EX40 (EX40)

CL Item

EX41 (EX41)

CL Item

EX42 (EX42)

CL Item

EX43 (EX43)

CL Item

EX44 (EX44)

CL Item

EX45 (EX45)

CL Item

EX46 (EX46)

CL Item

EX47 (EX47)

CL Item

EX48 (EX48)

CL Item

EX49 (EX49)

CL Item

EX50 (EX50)

CL Item

EX51 (EX51)

CL Item

EX52 (EX52)

CL Item

EX53 (EX53)

CL Item

EX54 (EX54)

CL Item

EX55 (EX55)

CL Item

EX56 (EX56)

CL Item

EX57 (EX57)

CL Item

EX58 (EX58)

CL Item

EX59 (EX59)

CL Item

EX60 (EX60)

CL Item

EX61 (EX61)

CL Item

EX62 (EX62)

CL Item

EX63 (EX63)

CL Item

EX64 (EX64)

CL Item

EX65 (EX65)

CL Item

EX66 (EX66)

CL Item

EX67 (EX67)

CL Item

EX1A (EX1A)

CL Item

EX4A (EX4A)

CL Item

EX3A (EX3A)

CL Item

EX5A (EX5A)

CL Item

EX6A (EX6A)

CL Item

EX7A (EX7A)

CL Item

EX8A (EX8A)

CL Item

EX9A (EX9A)

CL Item

EX10A (EX10A)

CL Item

EX13A (EX13A)

CL Item

EX15A (EX15A)

CL Item

EX16A (EX16A)

CL Item

EX17A (EX17A)

CL Item

EX18A (EX18A)

INEXC

Item

Exclusion criteria met

text

C1550543 (UMLS CUI [1, 1])
C0680251 (UMLS CUI [1,1])

YNF-1

Code List

Exclusion criteria met

CL Item

No (0)

C1298908 (UMLS CUI [1,1])

CL Item

Yes (1)

C1705108 (UMLS CUI [1,1])

INEXNM

Item

Exclusion criteria name

text

C0680251 (UMLS CUI [1, 1])
C0027365 (UMLS CUI [1,1])

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