ID

21992

Beskrivning

Patient Satisfaction Study of Single-Use Autoinjector for the Delivery of Pre-Filled Avonex Syringe; ODM derived from: https://clinicaltrials.gov/show/NCT00915577

Länk

https://clinicaltrials.gov/show/NCT00915577

Nyckelord

Versioner (1)
  1. 2017-05-13 2017-05-13 -
Uppladdad den

13 maj 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00915577

Engelsk

Eligibility Multiple Sclerosis NCT00915577

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
must be using liquid avonex® to treat ms. in addition, the subject must be on liquid avonex® for 12 weeks prior to the screening visit.
Beskrivning

Avonex liquid | Multiple Sclerosis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0594372
UMLS CUI [1,2]
C0302908
UMLS CUI [2]
C0026769
must have a bmi of 19 to 28 kg/m², inclusive, and a minimum body weight of 50 kg at screening.
Beskrivning

Body mass index | Body Weight Minimum

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2,1]
C0005910
UMLS CUI [2,2]
C1524031
must be able to physically demonstrate use of the device and be able to self-administer all injections.
Beskrivning

Medical Device Use of Able | Self Administration Injection Able

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0025080
UMLS CUI [1,2]
C1524063
UMLS CUI [1,3]
C0085732
UMLS CUI [2,1]
C0036589
UMLS CUI [2,2]
C1533685
UMLS CUI [2,3]
C0085732
must be english speaking.
Beskrivning

Able to speak English Language

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
must be able to understand and comply with the protocol.
Beskrivning

Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
abnormal screening or screening blood tests determined to be clinically significant by the investigator for: white blood count (wbc) or differential, platelet count, hemoglobin, serum creatinine, bilirubin, alanine transaminase (alt) aspartate transaminase (ast), prothrombin time (pt).
Beskrivning

Abnormal finding on screening procedure | Blood test abnormal | White Blood Cell Count procedure | Differential white blood cell count procedure | Platelet Count measurement | Hemoglobin measurement | Creatinine measurement, serum | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Prothrombin time

Datatyp

boolean

Alias
UMLS CUI [1]
C0421340
UMLS CUI [2]
C0854146
UMLS CUI [3]
C0023508
UMLS CUI [4]
C0162401
UMLS CUI [5]
C0032181
UMLS CUI [6]
C0518015
UMLS CUI [7]
C0201976
UMLS CUI [8]
C1278039
UMLS CUI [9]
C0201836
UMLS CUI [10]
C0201899
UMLS CUI [11]
C0033707
known sensitivity to dry natural rubber.
Beskrivning

Hypersensitivity Rubber Dry

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0035918
UMLS CUI [1,3]
C0205222
treatment with other agents to treat ms symptoms or underlying disease as specified in the protocol.
Beskrivning

Pharmaceutical Preparations | Multiple Sclerosis Symptoms Treating | Comorbidity Treating

Datatyp

boolean

Alias
UMLS CUI [1]
C0013227
UMLS CUI [2,1]
C0026769
UMLS CUI [2,2]
C1457887
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C1522326
history of severe allergic or anaphylactic reactions.
Beskrivning

Allergic Reaction Severe | Anaphylaxis Severe

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0002792
UMLS CUI [2,2]
C0205082
history of intolerance to acetaminophen (paracetamol), ibuprofen, naproxen, and aspirin that would preclude the use of at least one of these during the study.
Beskrivning

intolerance to Acetaminophen | intolerance to Ibuprofen | intolerance to Naproxen | intolerance to Aspirin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0000970
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0020740
UMLS CUI [3,1]
C1744706
UMLS CUI [3,2]
C0027396
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C0004057
serious local infection
Beskrivning

Local infection Serious

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1400591
UMLS CUI [1,2]
C0205404
other inclusion and exclusion criteria apply as per biogen idec protocol
Beskrivning

Clinical Trial Eligibility Criteria Study Protocol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Multiple Sclerosis NCT00915577

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Avonex liquid | Multiple Sclerosis
Item
must be using liquid avonex® to treat ms. in addition, the subject must be on liquid avonex® for 12 weeks prior to the screening visit.
boolean
C0594372 (UMLS CUI [1,1])
C0302908 (UMLS CUI [1,2])
C0026769 (UMLS CUI [2])
Body mass index | Body Weight Minimum
Item
must have a bmi of 19 to 28 kg/m², inclusive, and a minimum body weight of 50 kg at screening.
boolean
C1305855 (UMLS CUI [1])
C0005910 (UMLS CUI [2,1])
C1524031 (UMLS CUI [2,2])
Medical Device Use of Able | Self Administration Injection Able
Item
must be able to physically demonstrate use of the device and be able to self-administer all injections.
boolean
C0025080 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C0036589 (UMLS CUI [2,1])
C1533685 (UMLS CUI [2,2])
C0085732 (UMLS CUI [2,3])
Able to speak English Language
Item
must be english speaking.
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
Protocol Compliance
Item
must be able to understand and comply with the protocol.
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Abnormal finding on screening procedure | Blood test abnormal | White Blood Cell Count procedure | Differential white blood cell count procedure | Platelet Count measurement | Hemoglobin measurement | Creatinine measurement, serum | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Prothrombin time
Item
abnormal screening or screening blood tests determined to be clinically significant by the investigator for: white blood count (wbc) or differential, platelet count, hemoglobin, serum creatinine, bilirubin, alanine transaminase (alt) aspartate transaminase (ast), prothrombin time (pt).
boolean
C0421340 (UMLS CUI [1])
C0854146 (UMLS CUI [2])
C0023508 (UMLS CUI [3])
C0162401 (UMLS CUI [4])
C0032181 (UMLS CUI [5])
C0518015 (UMLS CUI [6])
C0201976 (UMLS CUI [7])
C1278039 (UMLS CUI [8])
C0201836 (UMLS CUI [9])
C0201899 (UMLS CUI [10])
C0033707 (UMLS CUI [11])
Hypersensitivity Rubber Dry
Item
known sensitivity to dry natural rubber.
boolean
C0020517 (UMLS CUI [1,1])
C0035918 (UMLS CUI [1,2])
C0205222 (UMLS CUI [1,3])
Pharmaceutical Preparations | Multiple Sclerosis Symptoms Treating | Comorbidity Treating
Item
treatment with other agents to treat ms symptoms or underlying disease as specified in the protocol.
boolean
C0013227 (UMLS CUI [1])
C0026769 (UMLS CUI [2,1])
C1457887 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C0009488 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
Allergic Reaction Severe | Anaphylaxis Severe
Item
history of severe allergic or anaphylactic reactions.
boolean
C1527304 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0002792 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
intolerance to Acetaminophen | intolerance to Ibuprofen | intolerance to Naproxen | intolerance to Aspirin
Item
history of intolerance to acetaminophen (paracetamol), ibuprofen, naproxen, and aspirin that would preclude the use of at least one of these during the study.
boolean
C1744706 (UMLS CUI [1,1])
C0000970 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0020740 (UMLS CUI [2,2])
C1744706 (UMLS CUI [3,1])
C0027396 (UMLS CUI [3,2])
C1744706 (UMLS CUI [4,1])
C0004057 (UMLS CUI [4,2])
Local infection Serious
Item
serious local infection
boolean
C1400591 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Clinical Trial Eligibility Criteria Study Protocol
Item
other inclusion and exclusion criteria apply as per biogen idec protocol
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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