ID

37367

Descrição

Study ID: 111592 Clinical Study ID: 111592 Study Title: A Randomized, Double-blind, Placebo-controlled, Doseescalation Study to Assess the Anti-inflammatory Activity, Efficacy, and Safety of Intravenous SB-681323 in Subjects at Risk for Development of Acute Lung Injury or ARDS Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00996840 See https://clinicaltrials.gov/ct2/show/NCT00996840 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Placebo, SB-681323 Trade Name: N/A Study Indication: Lung Injury, Acute The primary objective of this phase 2 trial is to evaluate the safety and tolerability of intravenous dilmapimod/SB-681323 given in escalating dosages and over different intervals for three days in trauma patients at risk for the development of ALI or ARDS. This study consists of Screening, infusion of dilmapimod/SB-681323 on days 1-3, examination/sampling up to early day 5 (denoted as "Day 3 - 48 hrs") and a Follow-up on day 7. There are four cohorts, cohorts 1 and 3 receive the medication (or placebo) infusion over 4 hours, cohorts 2 and 4 over 24 hours. This form contains the Eligibility Criteria the participant has to meet, and is to be filled in at Screening.

Link

https://clinicaltrials.gov/ct2/show/NCT00996840

Palavras-chave

Versões (1)
  1. 20/07/19 20/07/19 -
Titular dos direitos

GlaxoSmithKline

Transferido a

20 luglio 2019

DOI

Para um pedido faça login.

Licença

Creative Commons BY-NC 3.0
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SB-681323 in ALI/ARDS risk patients - NCT00996840

Inglês

Eligibility Criteria

1 Formulários  
  1. StudyEvent: ODM
    1. Eligibility Criteria
Administrative Data
Descrição

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Descrição

Subject Number

Tipo de dados

integer

Alias
UMLS CUI [1]
C2348585
Date/Time of Assessment
Descrição

Date/Time of Assessment

Tipo de dados

datetime

Alias
UMLS CUI [1,1]
C1516048
UMLS CUI [1,2]
C1264639
Eligibility Criteria
Descrição

Eligibility Criteria

Alias
UMLS CUI-1
C1516637
Did the subject meet all the entry criteria?
Descrição

If no, please select all boxes corresponding to violations of any inclusion/exclusion criteria

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C1550543
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Male or female, 18 - 80 years of age (inclusive)
Descrição

Gender and Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
Patients with major trauma admitted to the emergency department, ICU, step-down, or equivalent unit
Descrição

major trauma and admitted to emergency department, ICU, step-down or equivalent unit

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0205404
UMLS CUI [1,2]
C3714660
UMLS CUI [2]
C0583239
UMLS CUI [3]
C0583237
UMLS CUI [4,1]
C1627345
UMLS CUI [4,2]
C0030673
UMLS CUI [5,1]
C0030673
UMLS CUI [5,2]
C0205163
UMLS CUI [5,3]
C0019988
Injury Severity score (ISS) >=16 to <70
Descrição

Injury Severity score

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021504
A female subject is eligible to participate if she is of non-child-bearing potential or of child-bearing potential and agrees to use one of the contraception methods listed in Section 8.1 for an appropriate period of time (as determined by the product label or investigator, if applicable).
Descrição

Female subjects must agree to use contraception until one week post-last dose, if applicable.

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C0449238
Male subjects must agree to use one of the contraception methods listed in Section 8.1, if applicable. This criterion must be followed from the time of the first dose of study medication until one week post-last dose, if applicable
Descrição

Male contraception

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0086580
UMLS CUI [1,2]
C0449238
BMI within the range 19.0 - 40.0 kg/m2 inclusive
Descrição

clinical estimate of height and weight is acceptable

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1305855
The subject or legal decision maker is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
Descrição

Informed Consent and Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
QTcB or QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block
Descrição

QTcB or QTcF time or QTC in subjects with Bundle Branch Block

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1882513
UMLS CUI [2]
C1882512
UMLS CUI [3,1]
C0489625
UMLS CUI [3,2]
C0006384
The subject must be randomized into the study within 24-26 hours from the time of trauma.
Descrição

Time between trauma and randomization

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1272706
UMLS CUI [1,2]
C3714660
UMLS CUI [1,3]
C0034656
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Known positive Hepatitis B surface antigen or Hepatitis C antibody.
Descrição

Known HbsAg or HCV antibody

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0205309
UMLS CUI [1,2]
C0149709
UMLS CUI [2,1]
C0205309
UMLS CUI [2,2]
C0281863
Known positive test for HIV antibody
Descrição

Known positive HIV antibody

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0920548
UMLS CUI [1,2]
C0205309
A known history of substance abuse or alcohol abuse, within 6 months of the study causing chronic liver disease such as cirrhosis, chronic ascites or portal hypertension, or known evidence of withdrawal syndrome within the past 6 months.
Descrição

Recent history of substance abuse or alcohol abuse causing liver disease such as cirrhosis, chronic ascites or portal hypertension, or recent withdrawal syndrome

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C0085762
UMLS CUI [1,3]
C0678227
UMLS CUI [1,4]
C0341439
UMLS CUI [2,1]
C0332185
UMLS CUI [2,2]
C0038586
UMLS CUI [2,3]
C0678227
UMLS CUI [2,4]
C0341439
UMLS CUI [3,1]
C0332185
UMLS CUI [3,2]
C0085762
UMLS CUI [3,3]
C0678227
UMLS CUI [3,4]
C0023890
UMLS CUI [4,1]
C0332185
UMLS CUI [4,2]
C0038586
UMLS CUI [4,3]
C0678227
UMLS CUI [4,4]
C0023890
UMLS CUI [5,1]
C0332185
UMLS CUI [5,2]
C0085762
UMLS CUI [5,3]
C0678227
UMLS CUI [5,4]
C0008679
UMLS CUI [5,5]
C0003962
UMLS CUI [6,1]
C0332185
UMLS CUI [6,2]
C0038586
UMLS CUI [6,3]
C0678227
UMLS CUI [6,4]
C0008679
UMLS CUI [6,5]
C0003962
UMLS CUI [7,1]
C0332185
UMLS CUI [7,2]
C0085762
UMLS CUI [7,3]
C0678227
UMLS CUI [7,4]
C0020541
UMLS CUI [8,1]
C0332185
UMLS CUI [8,2]
C0038586
UMLS CUI [8,3]
C0678227
UMLS CUI [8,4]
C0020541
UMLS CUI [9,1]
C0332185
UMLS CUI [9,2]
C0038587
The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer)
Descrição

Recent clinical trial participation with recent investigational product administration

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C0332185
History of sensitivity to any of the study medications, or components thereof, or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation
Descrição

Sensitivity to study medications or their components, or drug or other allergy contraindicating participation

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1705248
UMLS CUI [2,3]
C0013230
UMLS CUI [3,1]
C0013182
UMLS CUI [3,2]
C1301624
UMLS CUI [3,3]
C2348568
UMLS CUI [4,1]
C0205394
UMLS CUI [4,2]
C0020517
UMLS CUI [4,3]
C1301624
UMLS CUI [4,4]
C2348568
Hemoglobin < 7g/dL.
Descrição

Hemoglobin

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019046
Pregnant females as determined by positive serum or urine hCG test prior to dosing
Descrição

Pregnancy (by serum or urine hCG test)

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0430056
UMLS CUI [3]
C0430060
Lactating females.
Descrição

Lactating females

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2828358
Unwillingness or inability to follow the procedures outlined in the protocol
Descrição

Unwillingness or inability to follow protocol

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1299582
History of sensitivity to heparin or heparin-induced thrombocytopenia
Descrição

sensitivity to heparin or heparin-induced thrombocytopenia

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0019134
UMLS CUI [2]
C0272285
Diagnosis of ALI at admission
Descrição

ALI at admission

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0242488
UMLS CUI [1,2]
C0030673
Head trauma (Abbreviated Injury Score [AIS]>4) or evidence of uncontrolled intracranial hypertension (ICP >20 mmHg despite therapy), liver trauma (AIS>2), or trauma that in the opinion of the Principle Investigator or GSK medical monitor is deemed unsurvivable
Descrição

Head trauma by AIS, uncontrolled intracranial hypertension by ICP, liver trauma by score, or trauma deemed unsurvivable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0018674
UMLS CUI [1,2]
C0000722
UMLS CUI [2,1]
C0151740
UMLS CUI [2,2]
C0205269
UMLS CUI [3]
C0021880
UMLS CUI [4,1]
C0000722
UMLS CUI [4,2]
C0160390
UMLS CUI [5,1]
C0871010
UMLS CUI [5,2]
C3714660
UMLS CUI [5,3]
C3151529
Known history of neuromuscular disease or cord injury at C5 or above
Descrição

Known history of neuromuscular disease or high cord injury

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0205309
UMLS CUI [1,2]
C0027868
UMLS CUI [2,1]
C0037929
UMLS CUI [2,2]
C1515974
Elevated ALT > 5x ULN
Descrição

ALT

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201836
History of bone marrow or solid organ transplant
Descrição

History of bone marrow or solid organ transplant

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0730400
UMLS CUI [2]
C0005961
Known history of auto-immune disorder in which immunosuppressive agents, other than prednisone, were required within the last 6 weeks
Descrição

auto-immune disorder requiring recent immunosuppressive agents other than prednisone

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C0332185
UMLS CUI [1,3]
C1555447
UMLS CUI [1,4]
C0021081
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0032952
Known to be receiving oral or intravenous corticosteroids within 7 days of admission
Descrição

recent oral or intravenous corticosteroids

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0442027
UMLS CUI [1,3]
C0332185
UMLS CUI [2,1]
C0332185
UMLS CUI [2,2]
C0348016
UMLS CUI [2,3]
C0001617
Subject with active tuberculosis or being treated for active tuberculosis.
Descrição

active tuberculosis or being treated for active tuberculosis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0151332
UMLS CUI [2,1]
C0013216
UMLS CUI [2,2]
C0151332
Known history of malignancy within the past 5 years with the exception of successfully treated squamous cell or basal cell cancer of the skin
Descrição

previous malignancy other than successfully treated nonmelanomatous skin cancer

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1518408
UMLS CUI [2,3]
C0007114
UMLS CUI [2,4]
C0580352
UMLS CUI [2,5]
C1272703
Arterial blood pH less than 7.1 or serum HCO3- <15 before infusion is started
Descrição

arterial blood pH and serum bicarbonate before infusion

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0428199
UMLS CUI [1,2]
C0585032
UMLS CUI [1,3]
C0574032
UMLS CUI [2,1]
C0202059
UMLS CUI [2,2]
C0585032
UMLS CUI [2,3]
C0574032
Persistent cardiovascular instability requiring therapy with more than one vasopressor
Descrição

Persistent cardiovascular instability requiring vasopressors

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0205322
UMLS CUI [1,2]
C0948268
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0042397
UMLS CUI [2,3]
C0449788
A patient will be excluded if in the judgement of the Principle Investigator or GSK medical monitor their participation could jeopardize the health of the subject or the integrity of the study.
Descrição

participation could jeopardize subject's health or integrity of study

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0035647
UMLS CUI [1,3]
C0018684
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C0035647
UMLS CUI [2,3]
C1947912
UMLS CUI [2,4]
C0008976
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Eligibility Criteria

1 Formulários
  1. StudyEvent: ODM
    1. Eligibility Criteria
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Date/Time of Assessment
Item
Date/Time of Assessment
datetime
C1516048 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Item Group
Eligibility Criteria
C1516637 (UMLS CUI-1)
entry criteria
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Gender and Age
Item
Male or female, 18 - 80 years of age (inclusive)
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
major trauma and admitted to emergency department, ICU, step-down or equivalent unit
Item
Patients with major trauma admitted to the emergency department, ICU, step-down, or equivalent unit
boolean
C0205404 (UMLS CUI [1,1])
C3714660 (UMLS CUI [1,2])
C0583239 (UMLS CUI [2])
C0583237 (UMLS CUI [3])
C1627345 (UMLS CUI [4,1])
C0030673 (UMLS CUI [4,2])
C0030673 (UMLS CUI [5,1])
C0205163 (UMLS CUI [5,2])
C0019988 (UMLS CUI [5,3])
Injury Severity score
Item
Injury Severity score (ISS) >=16 to <70
boolean
C0021504 (UMLS CUI [1])
Females of non-child-bearing potential or contraception
Item
A female subject is eligible to participate if she is of non-child-bearing potential or of child-bearing potential and agrees to use one of the contraception methods listed in Section 8.1 for an appropriate period of time (as determined by the product label or investigator, if applicable).
boolean
C3831118 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0700589 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Male contraception
Item
Male subjects must agree to use one of the contraception methods listed in Section 8.1, if applicable. This criterion must be followed from the time of the first dose of study medication until one week post-last dose, if applicable
boolean
C0086580 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
BMI
Item
BMI within the range 19.0 - 40.0 kg/m2 inclusive
boolean
C1305855 (UMLS CUI [1])
Informed Consent and Compliance
Item
The subject or legal decision maker is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
QTcB or QTcF time or QTC in subjects with Bundle Branch Block
Item
QTcB or QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block
boolean
C1882513 (UMLS CUI [1])
C1882512 (UMLS CUI [2])
C0489625 (UMLS CUI [3,1])
C0006384 (UMLS CUI [3,2])
Time between trauma and randomization
Item
The subject must be randomized into the study within 24-26 hours from the time of trauma.
boolean
C1272706 (UMLS CUI [1,1])
C3714660 (UMLS CUI [1,2])
C0034656 (UMLS CUI [1,3])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Known HbsAg or HCV antibody
Item
Known positive Hepatitis B surface antigen or Hepatitis C antibody.
boolean
C0205309 (UMLS CUI [1,1])
C0149709 (UMLS CUI [1,2])
C0205309 (UMLS CUI [2,1])
C0281863 (UMLS CUI [2,2])
Known positive HIV antibody
Item
Known positive test for HIV antibody
boolean
C0920548 (UMLS CUI [1,1])
C0205309 (UMLS CUI [1,2])
Recent history of substance abuse or alcohol abuse causing liver disease such as cirrhosis, chronic ascites or portal hypertension, or recent withdrawal syndrome
Item
A known history of substance abuse or alcohol abuse, within 6 months of the study causing chronic liver disease such as cirrhosis, chronic ascites or portal hypertension, or known evidence of withdrawal syndrome within the past 6 months.
boolean
C0332185 (UMLS CUI [1,1])
C0085762 (UMLS CUI [1,2])
C0678227 (UMLS CUI [1,3])
C0341439 (UMLS CUI [1,4])
C0332185 (UMLS CUI [2,1])
C0038586 (UMLS CUI [2,2])
C0678227 (UMLS CUI [2,3])
C0341439 (UMLS CUI [2,4])
C0332185 (UMLS CUI [3,1])
C0085762 (UMLS CUI [3,2])
C0678227 (UMLS CUI [3,3])
C0023890 (UMLS CUI [3,4])
C0332185 (UMLS CUI [4,1])
C0038586 (UMLS CUI [4,2])
C0678227 (UMLS CUI [4,3])
C0023890 (UMLS CUI [4,4])
C0332185 (UMLS CUI [5,1])
C0085762 (UMLS CUI [5,2])
C0678227 (UMLS CUI [5,3])
C0008679 (UMLS CUI [5,4])
C0003962 (UMLS CUI [5,5])
C0332185 (UMLS CUI [6,1])
C0038586 (UMLS CUI [6,2])
C0678227 (UMLS CUI [6,3])
C0008679 (UMLS CUI [6,4])
C0003962 (UMLS CUI [6,5])
C0332185 (UMLS CUI [7,1])
C0085762 (UMLS CUI [7,2])
C0678227 (UMLS CUI [7,3])
C0020541 (UMLS CUI [7,4])
C0332185 (UMLS CUI [8,1])
C0038586 (UMLS CUI [8,2])
C0678227 (UMLS CUI [8,3])
C0020541 (UMLS CUI [8,4])
C0332185 (UMLS CUI [9,1])
C0038587 (UMLS CUI [9,2])
Recent clinical trial participation with recent investigational product administration
Item
The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer)
boolean
C2348568 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0332185 (UMLS CUI [2,3])
Sensitivity to study medications or their components, or drug or other allergy contraindicating participation
Item
History of sensitivity to any of the study medications, or components thereof, or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1705248 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C0013182 (UMLS CUI [3,1])
C1301624 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C0205394 (UMLS CUI [4,1])
C0020517 (UMLS CUI [4,2])
C1301624 (UMLS CUI [4,3])
C2348568 (UMLS CUI [4,4])
Hemoglobin
Item
Hemoglobin < 7g/dL.
boolean
C0019046 (UMLS CUI [1])
Pregnancy (by serum or urine hCG test)
Item
Pregnant females as determined by positive serum or urine hCG test prior to dosing
boolean
C0032961 (UMLS CUI [1])
C0430056 (UMLS CUI [2])
C0430060 (UMLS CUI [3])
Lactating females
Item
Lactating females.
boolean
C2828358 (UMLS CUI [1])
Unwillingness or inability to follow protocol
Item
Unwillingness or inability to follow the procedures outlined in the protocol
boolean
C0525058 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
sensitivity to heparin or heparin-induced thrombocytopenia
Item
History of sensitivity to heparin or heparin-induced thrombocytopenia
boolean
C0020517 (UMLS CUI [1,1])
C0019134 (UMLS CUI [1,2])
C0272285 (UMLS CUI [2])
ALI at admission
Item
Diagnosis of ALI at admission
boolean
C0242488 (UMLS CUI [1,1])
C0030673 (UMLS CUI [1,2])
Head trauma by AIS, uncontrolled intracranial hypertension by ICP, liver trauma by score, or trauma deemed unsurvivable
Item
Head trauma (Abbreviated Injury Score [AIS]>4) or evidence of uncontrolled intracranial hypertension (ICP >20 mmHg despite therapy), liver trauma (AIS>2), or trauma that in the opinion of the Principle Investigator or GSK medical monitor is deemed unsurvivable
boolean
C0018674 (UMLS CUI [1,1])
C0000722 (UMLS CUI [1,2])
C0151740 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
C0021880 (UMLS CUI [3])
C0000722 (UMLS CUI [4,1])
C0160390 (UMLS CUI [4,2])
C0871010 (UMLS CUI [5,1])
C3714660 (UMLS CUI [5,2])
C3151529 (UMLS CUI [5,3])
Known history of neuromuscular disease or high cord injury
Item
Known history of neuromuscular disease or cord injury at C5 or above
boolean
C0205309 (UMLS CUI [1,1])
C0027868 (UMLS CUI [1,2])
C0037929 (UMLS CUI [2,1])
C1515974 (UMLS CUI [2,2])
ALT
Item
Elevated ALT > 5x ULN
boolean
C0201836 (UMLS CUI [1])
History of bone marrow or solid organ transplant
Item
History of bone marrow or solid organ transplant
boolean
C0730400 (UMLS CUI [1])
C0005961 (UMLS CUI [2])
auto-immune disorder requiring recent immunosuppressive agents other than prednisone
Item
Known history of auto-immune disorder in which immunosuppressive agents, other than prednisone, were required within the last 6 weeks
boolean
C0004364 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C1555447 (UMLS CUI [1,3])
C0021081 (UMLS CUI [1,4])
C1705847 (UMLS CUI [2,1])
C0032952 (UMLS CUI [2,2])
recent oral or intravenous corticosteroids
Item
Known to be receiving oral or intravenous corticosteroids within 7 days of admission
boolean
C0001617 (UMLS CUI [1,1])
C0442027 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C0332185 (UMLS CUI [2,1])
C0348016 (UMLS CUI [2,2])
C0001617 (UMLS CUI [2,3])
active tuberculosis or being treated for active tuberculosis
Item
Subject with active tuberculosis or being treated for active tuberculosis.
boolean
C0151332 (UMLS CUI [1])
C0013216 (UMLS CUI [2,1])
C0151332 (UMLS CUI [2,2])
previous malignancy other than successfully treated nonmelanomatous skin cancer
Item
Known history of malignancy within the past 5 years with the exception of successfully treated squamous cell or basal cell cancer of the skin
boolean
C0006826 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1518408 (UMLS CUI [2,2])
C0007114 (UMLS CUI [2,3])
C0580352 (UMLS CUI [2,4])
C1272703 (UMLS CUI [2,5])
arterial blood pH and serum bicarbonate before infusion
Item
Arterial blood pH less than 7.1 or serum HCO3- <15 before infusion is started
boolean
C0428199 (UMLS CUI [1,1])
C0585032 (UMLS CUI [1,2])
C0574032 (UMLS CUI [1,3])
C0202059 (UMLS CUI [2,1])
C0585032 (UMLS CUI [2,2])
C0574032 (UMLS CUI [2,3])
Persistent cardiovascular instability requiring vasopressors
Item
Persistent cardiovascular instability requiring therapy with more than one vasopressor
boolean
C0205322 (UMLS CUI [1,1])
C0948268 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C0042397 (UMLS CUI [2,2])
C0449788 (UMLS CUI [2,3])
participation could jeopardize subject's health or integrity of study
Item
A patient will be excluded if in the judgement of the Principle Investigator or GSK medical monitor their participation could jeopardize the health of the subject or the integrity of the study.
boolean
C2348568 (UMLS CUI [1,1])
C0035647 (UMLS CUI [1,2])
C0018684 (UMLS CUI [1,3])
C2348568 (UMLS CUI [2,1])
C0035647 (UMLS CUI [2,2])
C1947912 (UMLS CUI [2,3])
C0008976 (UMLS CUI [2,4])
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