ID

43081

Description

ODM derived from http://clinicaltrials.gov/show/NCT01335477

Link

http://clinicaltrials.gov/show/NCT01335477

Keywords

Versions (3)
  1. 3/21/13 3/21/13 - Martin Dugas
  2. 4/19/14 4/19/14 - Julian Varghese
  3. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT01335477 Pulmonary Fibrosis

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

age at least 40 Years
Description

age at least 40 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
IPF diagnosed, according to most recent American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS), Latin American Thoracic Association (ALAT) IPF guideline for diagnosis and management, within 5 years
Description

IPF diagnosed, according to most recent American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS), Latin American Thoracic Association (ALAT) IPF guideline for diagnosis and management, within 5 years

Data type

boolean

Alias
UMLS CUI 2011AA
C1800706
ICD-9-CM Version 2011
516.31
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0332290
SNOMED CT 2011_0131
385433004
UMLS CUI 2011AA
C1513491
HL7 V3 2006_05
RECENT
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0037459
UMLS CUI 2011AA
C0220845
Combination of High Resolution Computerized Tomography (HRCT) pattern, and if available surgical lung biopsy pattern, as assessed by central reviewers, are consistent with diagnosis of IPF
Description

Combination of High Resolution Computerized Tomography (HRCT) pattern, and if available surgical lung biopsy pattern, as assessed by central reviewers, are consistent with diagnosis of IPF

Data type

boolean

Alias
UMLS CUI 2011AA
C1947911
UMLS CUI 2011AA
C1512457
UMLS CUI 2011AA
C0543467
SNOMED CT 2011_0131
83578000
MedDRA 14.1
10051332
LOINC Version 232
MTHU000079
UMLS CUI 2011AA
C0189485
SNOMED CT 2011_0131
78603008
MedDRA 14.1
10004794
UMLS CUI 2011AA
C0449774
SNOMED CT 2011_0131
272135003
UMLS CUI 2011AA
C0332290
SNOMED CT 2011_0131
385433004
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C1800706
ICD-9-CM Version 2011
516.31
Dlco (corrected for Hb): 30%-79% predicted of normal
Description

Dlco (corrected for Hb): 30%-79% predicted of normal

Data type

boolean

Alias
UMLS CUI 2011AA
C1516251
UMLS CUI 2011AA
C0205202
SNOMED CT 2011_0131
33714007
UMLS CUI 2011AA
C0019046
SNOMED CT 2011_0131
38082009
MedDRA 14.1
10019481
LOINC Version 232
LP14449-0
Forced vital capacity
Description

FVC>= 50% predicted of normal

Data type

boolean

Alias
UMLS CUI 2011AA
C0802685
LOINC Version 232
19870-5
Exclusion Criteria
Description

Exclusion Criteria

Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) > 1.5 x Upper Limit of Normal (ULN)
Description

Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) > 1.5 x Upper Limit of Normal (ULN)

Data type

boolean

Alias
UMLS CUI 2011AA
C0004002
SNOMED CT 2011_0131
26091008
LOINC Version 232
MTHU004883
UMLS CUI 2011AA
C0001899
SNOMED CT 2011_0131
56935002
LOINC Version 232
MTHU006766
UMLS CUI 2011AA
C1519815
Bilirubin > 1.5 x ULN
Description

Bilirubin > 1.5 x ULN

Data type

boolean

Alias
UMLS CUI 2011AA
C1278039
SNOMED CT 2011_0131
79706000
LOINC Version 232
1975-2
Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC < 0.7)
Description

Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC < 0.7)

Data type

boolean

Alias
UMLS CUI 2011AA
C2347946
UMLS CUI 2011AA
C0001883
SNOMED CT 2011_0131
79688008
MedDRA 14.1
10001539
UMLS CUI 2011AA
C3166210
LOINC Version 232
MTHU037641
UMLS CUI 2011AA
C3166211
LOINC Version 232
MTHU037642
Patient likely to have lung transplantation during study (being on transplantation list is acceptable for participation)
Description

Patient likely to have lung transplantation during study (being on transplantation list is acceptable for participation)

Data type

boolean

Alias
UMLS CUI 2011AA
C0332148
SNOMED CT 2011_0131
2931005
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0024128
SNOMED CT 2011_0131
88039007
MedDRA 14.1
10025127
ICD-9-CM Version 2011
33.5
UMLS CUI 2011AA
C0347984
SNOMED CT 2011_0131
371881003
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Myocardial infarction within 6 months
Description

Myocardial infarction within 6 months

Data type

boolean

Alias
UMLS CUI 2011AA
C0027051
SNOMED CT 2011_0131
22298006
MedDRA 14.1
10028596
LOINC Version 232
MTHU035551
ICD-10-CM Version 2010
I21-I22
ICD-9-CM Version 2011
410
CTCAE 1105E
E10152
UMLS CUI 2011AA
C0332285
SNOMED CT 2011_0131
18720000
UMLS CUI 2011AA
C0205452
SNOMED CT 2011_0131
68244004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
Unstable angina within 1 month
Description

Unstable angina within 1 month

Data type

boolean

Alias
UMLS CUI 2011AA
C0002965
SNOMED CT 2011_0131
4557003
MedDRA 14.1
10002388
ICD-10-CM Version 2010
I20.0
ICD-9-CM Version 2011
411.1
UMLS CUI 2011AA
C0332285
SNOMED CT 2011_0131
18720000
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
Bleeding risk (genetic predisposition; fibrinolysis or full-dose therapeutic anticoagulation or high dose antiplatelet therapy; history of hemorrhagic CNS event within 12 months; haemoptysis or haematuria or active gastro-intestinal bleeding or ulcers or major injury or surgery within 3 months);
Description

Bleeding risk (genetic predisposition; fibrinolysis or full-dose therapeutic anticoagulation or high dose antiplatelet therapy; history of hemorrhagic CNS event within 12 months; haemoptysis or haematuria or active gastro-intestinal bleeding or ulcers or major injury or surgery within 3 months);

Data type

boolean

Alias
UMLS CUI 2011AA
C1458140
SNOMED CT 2011_0131
248250000
MedDRA 14.1
10005134
UMLS CUI 2011AA
C0314657
SNOMED CT 2011_0131
47708004
UMLS CUI 2011AA
C0016017
SNOMED CT 2011_0131
385538006
UMLS CUI 2011AA
C0443225
SNOMED CT 2011_0131
261015003
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C0003281
UMLS CUI 2011AA
C0444956
SNOMED CT 2011_0131
261829003
UMLS CUI 2011AA
C1096021
MedDRA 14.1
10053460
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C1560581
CTCAE 1105E
MTHU116769
UMLS CUI 2011AA
C0019079
SNOMED CT 2011_0131
66857006
MedDRA 14.1
10018964
ICD-10-CM Version 2010
R04.2
ICD-9-CM Version 2011
786.3
UMLS CUI 2011AA
C0018965
SNOMED CT 2011_0131
34436003
MedDRA 14.1
10018867
ICD-10-CM Version 2010
R31
ICD-9-CM Version 2011
599.7
CTCAE 1105E
E13000
UMLS CUI 2011AA
C0017181
SNOMED CT 2011_0131
74474003
MedDRA 14.1
10017955
ICD-10-CM Version 2010
K92.2
ICD-9-CM Version 2011
578
UMLS CUI 2011AA
C0041582
SNOMED CT 2011_0131
10045285
MedDRA 14.1
10045285
LOINC Version 232
MTHU022920
UMLS CUI 2011AA
C0332677
SNOMED CT 2011_0131
2734008
UMLS CUI 2011AA
C0679637
Thrombotic risk (inherited predisposition; history of thrombotic event (including stroke and transient ischemic attacks) within 12 months;
Description

Thrombotic risk (inherited predisposition; history of thrombotic event (including stroke and transient ischemic attacks) within 12 months;

Data type

boolean

Alias
UMLS CUI 2011AA
C2749785
UMLS CUI 2011AA
C0314657
SNOMED CT 2011_0131
47708004
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0040053
SNOMED CT 2011_0131
439127006
MedDRA 14.1
10043607
UMLS CUI 2011AA
C0038454
SNOMED CT 2011_0131
230690007
MedDRA 14.1
10042244
ICD-10-CM Version 2010
I63.9
CTCAE 1105E
E12826
UMLS CUI 2011AA
C0007787
SNOMED CT 2011_0131
266257000
MedDRA 14.1
10044390
LOINC Version 232
MTHU020810
ICD-10-CM Version 2010
G45.9
ICD-9-CM Version 2011
435.9
CTCAE 1105E
E12834
International normalised ratio (INR) > 2, prolongation of prothrombin time (PT) and partial thromboplastin time (PTT) by > 50% of institutional ULN)
Description

International normalised ratio (INR) > 2, prolongation of prothrombin time (PT) and partial thromboplastin time (PTT) by > 50% of institutional ULN)

Data type

boolean

Alias
UMLS CUI 2011AA
CL415281
UMLS CUI 2011AA
C2673577
UMLS CUI 2011AA
C0030605
SNOMED CT 2011_0131
42525009
MedDRA 14.1
10000630
UMLS CUI 2011AA
C1519815
N-ACetyl Cystein, prednisone > 15mg/day or equivalent received within 2 weeks of visit 1
Description

N-ACetyl Cystein, prednisone > 15mg/day or equivalent received within 2 weeks of visit 1

Data type

boolean

Alias
UMLS CUI 2011AA
C0699252
SNOMED CT 2011_0131
77731008
UMLS CUI 2011AA
C0032952
SNOMED CT 2011_0131
116602009
LOINC Version 232
MTHU003245
UMLS CUI 2011AA
CL415123
Pirfenidone, azathioprine, cyclophosphamide, cyclosporine A received within 8 weeks of visit 1
Description

Pirfenidone, azathioprine, cyclophosphamide, cyclosporine A received within 8 weeks of visit 1

Data type

boolean

Alias
UMLS CUI 2011AA
C0298067
SNOMED CT 2011_0131
438240001
UMLS CUI 2011AA
C0004482
SNOMED CT 2011_0131
372574004
LOINC Version 232
MTHU006794
UMLS CUI 2011AA
C0010583
SNOMED CT 2011_0131
387420009
LOINC Version 232
MTHU029970
UMLS CUI 2011AA
C0010592
SNOMED CT 2011_0131
387467008
LOINC Version 232
MTHU005140
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
age at least 40 Years
Item
age at least 40 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
IPF diagnosed, according to most recent American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS), Latin American Thoracic Association (ALAT) IPF guideline for diagnosis and management, within 5 years
Item
IPF diagnosed, according to most recent American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS), Latin American Thoracic Association (ALAT) IPF guideline for diagnosis and management, within 5 years
boolean
C1800706 (UMLS CUI 2011AA)
516.31 (ICD-9-CM Version 2011)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
C1513491 (UMLS CUI 2011AA)
RECENT (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0037459 (UMLS CUI 2011AA)
C0220845 (UMLS CUI 2011AA)
Combination of High Resolution Computerized Tomography (HRCT) pattern, and if available surgical lung biopsy pattern, as assessed by central reviewers, are consistent with diagnosis of IPF
Item
Combination of High Resolution Computerized Tomography (HRCT) pattern, and if available surgical lung biopsy pattern, as assessed by central reviewers, are consistent with diagnosis of IPF
boolean
C1947911 (UMLS CUI 2011AA)
C1512457 (UMLS CUI 2011AA)
C0543467 (UMLS CUI 2011AA)
83578000 (SNOMED CT 2011_0131)
10051332 (MedDRA 14.1)
MTHU000079 (LOINC Version 232)
C0189485 (UMLS CUI 2011AA)
78603008 (SNOMED CT 2011_0131)
10004794 (MedDRA 14.1)
C0449774 (UMLS CUI 2011AA)
272135003 (SNOMED CT 2011_0131)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C1800706 (UMLS CUI 2011AA)
516.31 (ICD-9-CM Version 2011)
Dlco (corrected for Hb): 30%-79% predicted of normal
Item
Dlco (corrected for Hb): 30%-79% predicted of normal
boolean
C1516251 (UMLS CUI 2011AA)
C0205202 (UMLS CUI 2011AA)
33714007 (SNOMED CT 2011_0131)
C0019046 (UMLS CUI 2011AA)
38082009 (SNOMED CT 2011_0131)
10019481 (MedDRA 14.1)
LP14449-0 (LOINC Version 232)
FVC>= 50% predicted of normal
Item
Forced vital capacity
boolean
C0802685 (UMLS CUI 2011AA)
19870-5 (LOINC Version 232)
Item Group
Exclusion Criteria
Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) > 1.5 x Upper Limit of Normal (ULN)
Item
Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) > 1.5 x Upper Limit of Normal (ULN)
boolean
C0004002 (UMLS CUI 2011AA)
26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
Bilirubin > 1.5 x ULN
Item
Bilirubin > 1.5 x ULN
boolean
C1278039 (UMLS CUI 2011AA)
79706000 (SNOMED CT 2011_0131)
1975-2 (LOINC Version 232)
Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC < 0.7)
Item
Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC < 0.7)
boolean
C2347946 (UMLS CUI 2011AA)
C0001883 (UMLS CUI 2011AA)
79688008 (SNOMED CT 2011_0131)
10001539 (MedDRA 14.1)
C3166210 (UMLS CUI 2011AA)
MTHU037641 (LOINC Version 232)
C3166211 (UMLS CUI 2011AA)
MTHU037642 (LOINC Version 232)
Patient likely to have lung transplantation during study (being on transplantation list is acceptable for participation)
Item
Patient likely to have lung transplantation during study (being on transplantation list is acceptable for participation)
boolean
C0332148 (UMLS CUI 2011AA)
2931005 (SNOMED CT 2011_0131)
C1514756 (UMLS CUI 2011AA)
C0024128 (UMLS CUI 2011AA)
88039007 (SNOMED CT 2011_0131)
10025127 (MedDRA 14.1)
33.5 (ICD-9-CM Version 2011)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Myocardial infarction within 6 months
Item
Myocardial infarction within 6 months
boolean
C0027051 (UMLS CUI 2011AA)
22298006 (SNOMED CT 2011_0131)
10028596 (MedDRA 14.1)
MTHU035551 (LOINC Version 232)
I21-I22 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
E10152 (CTCAE 1105E)
C0332285 (UMLS CUI 2011AA)
18720000 (SNOMED CT 2011_0131)
C0205452 (UMLS CUI 2011AA)
68244004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
Unstable angina within 1 month
Item
Unstable angina within 1 month
boolean
C0002965 (UMLS CUI 2011AA)
4557003 (SNOMED CT 2011_0131)
10002388 (MedDRA 14.1)
I20.0 (ICD-10-CM Version 2010)
411.1 (ICD-9-CM Version 2011)
C0332285 (UMLS CUI 2011AA)
18720000 (SNOMED CT 2011_0131)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
Bleeding risk (genetic predisposition; fibrinolysis or full-dose therapeutic anticoagulation or high dose antiplatelet therapy; history of hemorrhagic CNS event within 12 months; haemoptysis or haematuria or active gastro-intestinal bleeding or ulcers or major injury or surgery within 3 months);
Item
Bleeding risk (genetic predisposition; fibrinolysis or full-dose therapeutic anticoagulation or high dose antiplatelet therapy; history of hemorrhagic CNS event within 12 months; haemoptysis or haematuria or active gastro-intestinal bleeding or ulcers or major injury or surgery within 3 months);
boolean
C1458140 (UMLS CUI 2011AA)
248250000 (SNOMED CT 2011_0131)
10005134 (MedDRA 14.1)
C0314657 (UMLS CUI 2011AA)
47708004 (SNOMED CT 2011_0131)
C0016017 (UMLS CUI 2011AA)
385538006 (SNOMED CT 2011_0131)
C0443225 (UMLS CUI 2011AA)
261015003 (SNOMED CT 2011_0131)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0003281 (UMLS CUI 2011AA)
C0444956 (UMLS CUI 2011AA)
261829003 (SNOMED CT 2011_0131)
C1096021 (UMLS CUI 2011AA)
10053460 (MedDRA 14.1)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C1560581 (UMLS CUI 2011AA)
MTHU116769 (CTCAE 1105E)
C0019079 (UMLS CUI 2011AA)
66857006 (SNOMED CT 2011_0131)
10018964 (MedDRA 14.1)
R04.2 (ICD-10-CM Version 2010)
786.3 (ICD-9-CM Version 2011)
C0018965 (UMLS CUI 2011AA)
34436003 (SNOMED CT 2011_0131)
10018867 (MedDRA 14.1)
R31 (ICD-10-CM Version 2010)
599.7 (ICD-9-CM Version 2011)
E13000 (CTCAE 1105E)
C0017181 (UMLS CUI 2011AA)
74474003 (SNOMED CT 2011_0131)
10017955 (MedDRA 14.1)
K92.2 (ICD-10-CM Version 2010)
578 (ICD-9-CM Version 2011)
C0041582 (UMLS CUI 2011AA)
10045285 (SNOMED CT 2011_0131)
10045285 (MedDRA 14.1)
MTHU022920 (LOINC Version 232)
C0332677 (UMLS CUI 2011AA)
2734008 (SNOMED CT 2011_0131)
C0679637 (UMLS CUI 2011AA)
Thrombotic risk (inherited predisposition; history of thrombotic event (including stroke and transient ischemic attacks) within 12 months;
Item
Thrombotic risk (inherited predisposition; history of thrombotic event (including stroke and transient ischemic attacks) within 12 months;
boolean
C2749785 (UMLS CUI 2011AA)
C0314657 (UMLS CUI 2011AA)
47708004 (SNOMED CT 2011_0131)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0040053 (UMLS CUI 2011AA)
439127006 (SNOMED CT 2011_0131)
10043607 (MedDRA 14.1)
C0038454 (UMLS CUI 2011AA)
230690007 (SNOMED CT 2011_0131)
10042244 (MedDRA 14.1)
I63.9 (ICD-10-CM Version 2010)
E12826 (CTCAE 1105E)
C0007787 (UMLS CUI 2011AA)
266257000 (SNOMED CT 2011_0131)
10044390 (MedDRA 14.1)
MTHU020810 (LOINC Version 232)
G45.9 (ICD-10-CM Version 2010)
435.9 (ICD-9-CM Version 2011)
E12834 (CTCAE 1105E)
International normalised ratio (INR) > 2, prolongation of prothrombin time (PT) and partial thromboplastin time (PTT) by > 50% of institutional ULN)
Item
International normalised ratio (INR) > 2, prolongation of prothrombin time (PT) and partial thromboplastin time (PTT) by > 50% of institutional ULN)
boolean
CL415281 (UMLS CUI 2011AA)
C2673577 (UMLS CUI 2011AA)
C0030605 (UMLS CUI 2011AA)
42525009 (SNOMED CT 2011_0131)
10000630 (MedDRA 14.1)
C1519815 (UMLS CUI 2011AA)
N-ACetyl Cystein, prednisone > 15mg/day or equivalent received within 2 weeks of visit 1
Item
N-ACetyl Cystein, prednisone > 15mg/day or equivalent received within 2 weeks of visit 1
boolean
C0699252 (UMLS CUI 2011AA)
77731008 (SNOMED CT 2011_0131)
C0032952 (UMLS CUI 2011AA)
116602009 (SNOMED CT 2011_0131)
MTHU003245 (LOINC Version 232)
CL415123 (UMLS CUI 2011AA)
Pirfenidone, azathioprine, cyclophosphamide, cyclosporine A received within 8 weeks of visit 1
Item
Pirfenidone, azathioprine, cyclophosphamide, cyclosporine A received within 8 weeks of visit 1
boolean
C0298067 (UMLS CUI 2011AA)
438240001 (SNOMED CT 2011_0131)
C0004482 (UMLS CUI 2011AA)
372574004 (SNOMED CT 2011_0131)
MTHU006794 (LOINC Version 232)
C0010583 (UMLS CUI 2011AA)
387420009 (SNOMED CT 2011_0131)
MTHU029970 (LOINC Version 232)
C0010592 (UMLS CUI 2011AA)
387467008 (SNOMED CT 2011_0131)
MTHU005140 (LOINC Version 232)
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