ID

42735

Description

ODM derived from http://clinicaltrials.gov/show/NCT00925002

Link

http://clinicaltrials.gov/show/NCT00925002

Keywords

Versions (2)
  1. 12/9/13 12/9/13 - Martin Dugas
  2. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00925002 ATTR-PN

German English

Eligibility

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

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age 18 Years to 75 Years
Description

age 18 Years to 75 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
ATTR-PN
Description

ATTR-PN

Data type

boolean

Alias
UMLS CUI 2011AA
C0032923
SNOMED CT 2011_0131
37959007
LOINC Version 232
MTHU004200
UMLS CUI 2011AA
C0002726
SNOMED CT 2011_0131
17602002
MedDRA 14.1
10002022
LOINC Version 232
E85
ICD-10-CM Version 2010
277.3
UMLS CUI 2011AA
C0206247
SNOMED CT 2011_0131
193187004
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
Patient has successfully completed either Protocol Fx-006 or Fx1A-201.
Description

Patient has successfully completed either Protocol Fx-006 or Fx1A-201.

Data type

boolean

Alias
UMLS CUI 2011AA
C1272703
SNOMED CT 2011_0131
385669000
UMLS CUI 2011AA
C1554962
HL7 V3 2006_05
C
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C2348563
If female, patient is post-menopausal, surgically sterilized, or willing to use two acceptable methods of birth control (i.e., hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide) throughout the study and for 3 months from the end of the study. (A condom alone is not considered an acceptable method of birth control.)
Description

If female, patient is post-menopausal, surgically sterilized, or willing to use two acceptable methods of birth control (i.e., hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide) throughout the study and for 3 months from the end of the study. (A condom alone is not considered an acceptable method of birth control.)

Data type

boolean

Alias
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0232970
SNOMED CT 2011_0131
76498008
UMLS CUI 2011AA
C0543467
SNOMED CT 2011_0131
83578000
MedDRA 14.1
10051332
LOINC Version 232
MTHU000079
UMLS CUI 2011AA
C0038288
MedDRA 14.1
10062116
UMLS CUI 2011AA
C0600109
SNOMED CT 2011_0131
225466006
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
UMLS CUI 2011AA
CL424941
UMLS CUI 2011AA
C0021900
SNOMED CT 2011_0131
268460000
MedDRA 14.1
10022745
UMLS CUI 2011AA
C0042241
SNOMED CT 2011_0131
20359006
UMLS CUI 2011AA
C0677582
UMLS CUI 2011AA
C0037862
SNOMED CT 2011_0131
425484006
Patient is, in the opinion of the investigator, willing and able to comply with the investigational product regimen and all other study requirements.
Description

Patient is, in the opinion of the investigator, willing and able to comply with the investigational product regimen and all other study requirements.

Data type

boolean

Alias
UMLS CUI 2011AA
C1321605
SNOMED CT 2011_0131
405078008
UMLS CUI 2011AA
C0013230
UMLS CUI 2011AA
CL031856
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C1514873
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Patient has not successfully completed either Protocol Fx-006 or Fx1A-201.
Description

Patient has not successfully completed either Protocol Fx-006 or Fx1A-201.

Data type

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C1272703
SNOMED CT 2011_0131
385669000
UMLS CUI 2011AA
C1554962
HL7 V3 2006_05
C
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C2348563
Chronic use of non-protocol approved non-steroidal anti-inflammatory drugs (NSAIDs), defined as > 3 to 4 times/month. The following NSAIDs are allowed: acetylsalicylic acid, etodolac, ibuprofen, indomethicin, ketoprofen, nabumetone, naproxen, nimesulide, piroxicam, and sulindac.
Description

Chronic use of non-protocol approved non-steroidal anti-inflammatory drugs (NSAIDs), defined as > 3 to 4 times/month. The following NSAIDs are allowed: acetylsalicylic acid, etodolac, ibuprofen, indomethicin, ketoprofen, nabumetone, naproxen, nimesulide, piroxicam, and sulindac.

Data type

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C1706842
UMLS CUI 2011AA
C2348563
UMLS CUI 2011AA
C0003211
SNOMED CT 2011_0131
16403005, 372665008
UMLS CUI 2011AA
C0521104
SNOMED CT 2011_0131
75554001
UMLS CUI 2011AA
C0004057
SNOMED CT 2011_0131
7947003
UMLS CUI 2011AA
C0059865
SNOMED CT 2011_0131
108510003
LOINC Version 232
MTHU007028
UMLS CUI 2011AA
C0593507
SNOMED CT 2011_0131
387207008
LOINC Version 232
MTHU004262
UMLS CUI 2011AA
C0021246
SNOMED CT 2011_0131
60149003
LOINC Version 232
MTHU016716
UMLS CUI 2011AA
C0022635
SNOMED CT 2011_0131
10099000
LOINC Version 232
MTHU007198
UMLS CUI 2011AA
C0701331
SNOMED CT 2011_0131
108508000
LOINC Version 232
MTHU003376
UMLS CUI 2011AA
C0700017
SNOMED CT 2011_0131
11847009
LOINC Version 232
MTHU015374
UMLS CUI 2011AA
C0132515
UMLS CUI 2011AA
C0031990
SNOMED CT 2011_0131
27754002
LOINC Version 232
MTHU001848
UMLS CUI 2011AA
C0038792
SNOMED CT 2011_0131
89505005
LOINC Version 232
MTHU003386
If female, patient is pregnant or breast feeding.
Description

If female, patient is pregnant or breast feeding.

Data type

boolean

Alias
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
Clinically significant medical condition that, in the opinion of the investigator, would place the patient at an increased risk to participate in the study.
Description

Clinically significant medical condition that, in the opinion of the investigator, would place the patient at an increased risk to participate in the study.

Data type

boolean

Alias
UMLS CUI 2011AA
C1699700
HL7 V3 2006_05
MEDCCAT
UMLS CUI 2011AA
C0678227
SNOMED CT 2011_0131
23981006
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0205217
HL7 V3 2006_05
U
UMLS CUI 2011AA
C0035647
SNOMED CT 2011_0131
30207005
HL7 V3 2006_05
RSK
The patient has received a liver or heart transplant.
Description

The patient has received a liver or heart transplant.

Data type

boolean

Alias
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0023911
SNOMED CT 2011_0131
18027006
MedDRA 14.1
10024714
ICD-9-CM Version 2011
50.5
UMLS CUI 2011AA
C0018823
SNOMED CT 2011_0131
32413006
MedDRA 14.1
10019314
ICD-9-CM Version 2011
37.51
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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
CL425202 (UMLS CUI 2011AA)
age 18 Years to 75 Years
Item
age 18 Years to 75 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
ATTR-PN
Item
ATTR-PN
boolean
C0032923 (UMLS CUI 2011AA)
37959007 (SNOMED CT 2011_0131)
MTHU004200 (LOINC Version 232)
C0002726 (UMLS CUI 2011AA)
17602002 (SNOMED CT 2011_0131)
10002022 (MedDRA 14.1)
E85 (LOINC Version 232)
277.3 (ICD-10-CM Version 2010)
C0206247 (UMLS CUI 2011AA)
193187004 (SNOMED CT 2011_0131)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
Patient has successfully completed either Protocol Fx-006 or Fx1A-201.
Item
Patient has successfully completed either Protocol Fx-006 or Fx1A-201.
boolean
C1272703 (UMLS CUI 2011AA)
385669000 (SNOMED CT 2011_0131)
C1554962 (UMLS CUI 2011AA)
C (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C2348563 (UMLS CUI 2011AA)
If female, patient is post-menopausal, surgically sterilized, or willing to use two acceptable methods of birth control (i.e., hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide) throughout the study and for 3 months from the end of the study. (A condom alone is not considered an acceptable method of birth control.)
Item
If female, patient is post-menopausal, surgically sterilized, or willing to use two acceptable methods of birth control (i.e., hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide) throughout the study and for 3 months from the end of the study. (A condom alone is not considered an acceptable method of birth control.)
boolean
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0232970 (UMLS CUI 2011AA)
76498008 (SNOMED CT 2011_0131)
C0543467 (UMLS CUI 2011AA)
83578000 (SNOMED CT 2011_0131)
10051332 (MedDRA 14.1)
MTHU000079 (LOINC Version 232)
C0038288 (UMLS CUI 2011AA)
10062116 (MedDRA 14.1)
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
CL424941 (UMLS CUI 2011AA)
C0021900 (UMLS CUI 2011AA)
268460000 (SNOMED CT 2011_0131)
10022745 (MedDRA 14.1)
C0042241 (UMLS CUI 2011AA)
20359006 (SNOMED CT 2011_0131)
C0677582 (UMLS CUI 2011AA)
C0037862 (UMLS CUI 2011AA)
425484006 (SNOMED CT 2011_0131)
Patient is, in the opinion of the investigator, willing and able to comply with the investigational product regimen and all other study requirements.
Item
Patient is, in the opinion of the investigator, willing and able to comply with the investigational product regimen and all other study requirements.
boolean
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
C0013230 (UMLS CUI 2011AA)
CL031856 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1514873 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Patient has not successfully completed either Protocol Fx-006 or Fx1A-201.
Item
Patient has not successfully completed either Protocol Fx-006 or Fx1A-201.
boolean
C1518422 (UMLS CUI 2011AA)
C1272703 (UMLS CUI 2011AA)
385669000 (SNOMED CT 2011_0131)
C1554962 (UMLS CUI 2011AA)
C (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C2348563 (UMLS CUI 2011AA)
Chronic use of non-protocol approved non-steroidal anti-inflammatory drugs (NSAIDs), defined as > 3 to 4 times/month. The following NSAIDs are allowed: acetylsalicylic acid, etodolac, ibuprofen, indomethicin, ketoprofen, nabumetone, naproxen, nimesulide, piroxicam, and sulindac.
Item
Chronic use of non-protocol approved non-steroidal anti-inflammatory drugs (NSAIDs), defined as > 3 to 4 times/month. The following NSAIDs are allowed: acetylsalicylic acid, etodolac, ibuprofen, indomethicin, ketoprofen, nabumetone, naproxen, nimesulide, piroxicam, and sulindac.
boolean
C1518422 (UMLS CUI 2011AA)
C1706842 (UMLS CUI 2011AA)
C2348563 (UMLS CUI 2011AA)
C0003211 (UMLS CUI 2011AA)
16403005, 372665008 (SNOMED CT 2011_0131)
C0521104 (UMLS CUI 2011AA)
75554001 (SNOMED CT 2011_0131)
C0004057 (UMLS CUI 2011AA)
7947003 (SNOMED CT 2011_0131)
C0059865 (UMLS CUI 2011AA)
108510003 (SNOMED CT 2011_0131)
MTHU007028 (LOINC Version 232)
C0593507 (UMLS CUI 2011AA)
387207008 (SNOMED CT 2011_0131)
MTHU004262 (LOINC Version 232)
C0021246 (UMLS CUI 2011AA)
60149003 (SNOMED CT 2011_0131)
MTHU016716 (LOINC Version 232)
C0022635 (UMLS CUI 2011AA)
10099000 (SNOMED CT 2011_0131)
MTHU007198 (LOINC Version 232)
C0701331 (UMLS CUI 2011AA)
108508000 (SNOMED CT 2011_0131)
MTHU003376 (LOINC Version 232)
C0700017 (UMLS CUI 2011AA)
11847009 (SNOMED CT 2011_0131)
MTHU015374 (LOINC Version 232)
C0132515 (UMLS CUI 2011AA)
C0031990 (UMLS CUI 2011AA)
27754002 (SNOMED CT 2011_0131)
MTHU001848 (LOINC Version 232)
C0038792 (UMLS CUI 2011AA)
89505005 (SNOMED CT 2011_0131)
MTHU003386 (LOINC Version 232)
If female, patient is pregnant or breast feeding.
Item
If female, patient is pregnant or breast feeding.
boolean
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
Clinically significant medical condition that, in the opinion of the investigator, would place the patient at an increased risk to participate in the study.
Item
Clinically significant medical condition that, in the opinion of the investigator, would place the patient at an increased risk to participate in the study.
boolean
C1699700 (UMLS CUI 2011AA)
MEDCCAT (HL7 V3 2006_05)
C0678227 (UMLS CUI 2011AA)
23981006 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0205217 (UMLS CUI 2011AA)
U (HL7 V3 2006_05)
C0035647 (UMLS CUI 2011AA)
30207005 (SNOMED CT 2011_0131)
RSK (HL7 V3 2006_05)
The patient has received a liver or heart transplant.
Item
The patient has received a liver or heart transplant.
boolean
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C1514756 (UMLS CUI 2011AA)
C0023911 (UMLS CUI 2011AA)
18027006 (SNOMED CT 2011_0131)
10024714 (MedDRA 14.1)
50.5 (ICD-9-CM Version 2011)
C0018823 (UMLS CUI 2011AA)
32413006 (SNOMED CT 2011_0131)
10019314 (MedDRA 14.1)
37.51 (ICD-9-CM Version 2011)
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