ID

15355

Descrizione

Alemtuzumab in Autoimmune Inflammatory Neurodegeneration: Mechanisms of Action and Neuroprotective Potential; ODM derived from: https://clinicaltrials.gov/show/NCT02419378 Principal Investigator Prof. Dr. Dr. Sven Meuth, University Hospital Muenster, Germany

collegamento

https://clinicaltrials.gov/show/NCT02419378

Keywords

versioni (4)
  1. 18/08/15 18/08/15 - Martin Dugas
  2. 22/05/16 22/05/16 -
  3. 28/05/16 28/05/16 -
  4. 27/09/21 27/09/21 -
Caricato su

28 maggio 2016

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
Commenti del modello :

Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.

Torna ai commenti del modello
Commenti del gruppo di articoli per :

Commenti dell'articolo per :

  • i più nuovi
  • i più vecchi
  • Popolare
  • i più nuovi
    • i più nuovi
    • i più vecchi
    • Popolare

Non ci sono commenti

Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.

Eligibility Multiple Sclerosis, Relapsing-Remitting NCT02419378

Inglese

Eligibility Multiple Sclerosis, Relapsing-Remitting NCT02419378

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI-1
C1512693 (Inclusion)
1. signed informed consent form (icf)
Descrizione

signed informed consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430 (Informed Consent)
2. age 18 to 55 years old (inclusive) as of the date the icf is signed
Descrizione

2. age 18 to 55 years old (inclusive) as of the date the icf is signed

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779 (Age)
SNOMED
424144002
LOINC
LP28815-6
3. diagnosis of ms according to the mcdonald criteria 2010 and cranial mri scan demonstrating white matter lesions attributable to ms within 5 years before screening
Descrizione

3. diagnosis of ms according to the mcdonald criteria 2010 and cranial mri scan demonstrating white matter lesions attributable to ms within 5 years before screening

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0026769 (Multiple Sclerosis)
SNOMED
24700007
LOINC
LA14298-6
UMLS CUI [1,2]
C0917711 (MRI Scans)
LOINC
LA9478-4
4. onset of ms symptoms (as determined by a neurologist, either at present or retrospectively) within 5 years of the date the icf is signed
Descrizione

4. onset of ms symptoms (as determined by a neurologist, either at present or retrospectively) within 5 years of the date the icf is signed

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1457887 (Symptoms)
LOINC
MTHU021540
UMLS CUI [1,2]
C0332162 (Onset of (contextual qualifier))
SNOMED
77374008
UMLS CUI [1,3]
C0040223 (Time)
SNOMED
410670007
LOINC
LP73517-2
5. edss score 0.0 to 4.0 (inclusive) at screening
Descrizione

5. edss score 0.0 to 4.0 (inclusive) at screening

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0451246 (Kurtzke multiple sclerosis rating scale)
SNOMED
273554001
6. ≥2 ms relapses within 24 months or clinical (≥1 relapse) or mri (new gadolinium enhancing lesions) disease activity under therapy with interferon beta, glatirameracetate, natalizumab or fingolimod
Descrizione

6. ≥2 ms relapses within 24 months or clinical (≥1 relapse) or mri (new gadolinium enhancing lesions) disease activity under therapy with interferon beta, glatirameracetate, natalizumab or fingolimod

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2707252 (Active disease diagnosis)
LOINC
LP89688-3
7. indicated to receive alemtuzumab according to the investigator's assessment
Descrizione

7. indicated to receive alemtuzumab according to the investigator's assessment

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1548948 (Professional Judgment)
8. completion of all vaccinations required by the applicable immunization guidelines published by "ständige impfkommission" (stiko)
Descrizione

8. completion of all vaccinations required by the applicable immunization guidelines published by "ständige impfkommission" (stiko)

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0042196 (Vaccination)
SNOMED
33879002
LOINC
LP29692-8
9. history of chickenpox or positive test for antibodies against varicella zoster virus (vzv)
Descrizione

9. history of chickenpox or positive test for antibodies against varicella zoster virus (vzv)

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0008049 (Chickenpox)
SNOMED
38907003
LOINC
LA10517-3
UMLS CUI [2]
C0042338 (herpesvirus 3, human)
SNOMED
19551004
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI-1
C0680251 (Exclusion Criteria)
1. participation in another clinical trial at present or within 4 weeks of study entry. there may be exceptions at the discretion of the investigator.
Descrizione

1. participation in another clinical trial at present or within 4 weeks of study entry. there may be exceptions at the discretion of the investigator.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2348568 (Study Subject Participation Status)
2. has any progressive form of ms
Descrizione

2. has any progressive form of ms

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1095979 (undefined)
3. hypersensitivity to the active substance, or to any of the excipients of lemtrada
Descrizione

3. hypersensitivity to the active substance, or to any of the excipients of lemtrada

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0020517 (Hypersensitivity)
SNOMED
421961002
LOINC
LP20697-6
UMLS CUI [1,2]
C1372955 (Active ingredient)
4. medical, psychiatric, cognitive, or other conditions that, in the investigator's opinion, compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study
Descrizione

4. medical, psychiatric, cognitive, or other conditions that, in the investigator's opinion, compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0021430 (Informed Consent)
UMLS CUI [2,1]
C0525058 (Protocol Compliance)
5. any disability acquired from trauma or another illness that could interfere with evaluation of disability due to ms
Descrizione

5. any disability acquired from trauma or another illness that could interfere with evaluation of disability due to ms

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0231170 (Disability)
SNOMED
21134002
LOINC
MTHU064635
6. major systemic disease or other illness that would, in the opinion of the investigator, compromise patient safety or interfere with the interpretation of study results, e.g., current peptic ulcer disease or other conditions that may predispose to hemorrhage
Descrizione

6. major systemic disease or other illness that would, in the opinion of the investigator, compromise patient safety or interfere with the interpretation of study results, e.g., current peptic ulcer disease or other conditions that may predispose to hemorrhage

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0442893 (Systemic disease)
SNOMED
56019007
7. known bleeding disorder (e.g,. dysfibrinogenemia, factor ix deficiency, hemophilia, von willebrand's disease, disseminated intravascular coagulation (dic), fibrinogen deficiency, or clotting factor deficiency)
Descrizione

7. known bleeding disorder (e.g,. dysfibrinogenemia, factor ix deficiency, hemophilia, von willebrand's disease, disseminated intravascular coagulation (dic), fibrinogen deficiency, or clotting factor deficiency)

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3251812 (Bleeding risk)
LOINC
LP209013-4
8. significant autoimmune disease including but not limited to immune cytopenias, rheumatoid arthritis, systemic lupus erythematosus, other connective tissue disorders, vasculitis, inflammatory bowel disease, severe psoriasis
Descrizione

8. significant autoimmune disease including but not limited to immune cytopenias, rheumatoid arthritis, systemic lupus erythematosus, other connective tissue disorders, vasculitis, inflammatory bowel disease, severe psoriasis

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0004364 (Autoimmune Diseases)
SNOMED
85828009
9. history of malignancy, except basal skin cell carcinoma
Descrizione

9. history of malignancy, except basal skin cell carcinoma

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0006826 (Malignant Neoplasms)
SNOMED
363346000
LOINC
LP100805-3
10. major psychiatric disorder that is not adequately controlled by treatment
Descrizione

10. major psychiatric disorder that is not adequately controlled by treatment

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0004936 (Mental disorders)
SNOMED
74732009
UMLS CUI [1,2]
C0205318 (Uncontrolled)
SNOMED
19032002
11. epileptic seizures that are not adequately controlled by treatment
Descrizione

11. epileptic seizures that are not adequately controlled by treatment

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0036572 (Seizures)
SNOMED
91175000
LOINC
LA15899-0
UMLS CUI [1,2]
C0205318 (Uncontrolled)
SNOMED
19032002
12. active infection, e.g., deep-tissue infection, that the investigator considers sufficiently serious to preclude study participation
Descrizione

12. active infection, e.g., deep-tissue infection, that the investigator considers sufficiently serious to preclude study participation

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0009450 (Communicable Diseases)
SNOMED
189822004
13. in the investigator's opinion, is at high risk for infection (e.g., indwelling catheter, dysphagia with aspiration, decubitus ulcer, history of prior aspiration pneumonia or recurrent urinary tract infection)
Descrizione

13. in the investigator's opinion, is at high risk for infection (e.g., indwelling catheter, dysphagia with aspiration, decubitus ulcer, history of prior aspiration pneumonia or recurrent urinary tract infection)

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0582147 (At risk of infection)
SNOMED
78648007
14. seropositivity for human immunodeficiency virus (hiv)
Descrizione

14. seropositivity for human immunodeficiency virus (hiv)

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0019699 (HIV Seropositivity)
SNOMED
165816005
15. infection with hepatitis c virus
Descrizione

15. infection with hepatitis c virus

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0019196 (Hepatitis C)
SNOMED
50711007
LOINC
LA19423-5
16. past or present hepatitis b infection (positive hepatitis b serology)
Descrizione

16. past or present hepatitis b infection (positive hepatitis b serology)

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0019163 (Hepatitis B)
SNOMED
66071002
LOINC
LA18126-5
17. active infection with human cytomegaly virus (hcmv), epstein-barr virus (ebv), varicella-zoster virus (vzv)
Descrizione

17. active infection with human cytomegaly virus (hcmv), epstein-barr virus (ebv), varicella-zoster virus (vzv)

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0010825 (Cytomegalovirus)
SNOMED
407444007
LOINC
LP14255-1
UMLS CUI [2]
C0014644 (Epstein-Barr virus)
SNOMED
40168006
UMLS CUI [3]
C0042338 (herpesvirus 3, human)
SNOMED
19551004
18. latent tuberculosis unless effective anti-tuberculosis therapy has been completed, or active tuberculosis.
Descrizione

18. latent tuberculosis unless effective anti-tuberculosis therapy has been completed, or active tuberculosis.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0041296 (Tuberculosis)
SNOMED
373576009
LOINC
LP28599-6
19. invasive fungal infections in history and at present
Descrizione

19. invasive fungal infections in history and at present

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0026946 (Mycoses)
SNOMED
3218000
20. cervical cytology other than pap I or pap II (papanicolaou) or cervical high risk human papillomavirus (hpv) positivity
Descrizione

20. cervical cytology other than pap I or pap II (papanicolaou) or cervical high risk human papillomavirus (hpv) positivity

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0856201 (Cervical cytology)
21. any other illness or infection (latent or active) that, in the investigator's opinion, could be exacerbated by study medication
Descrizione

21. any other illness or infection (latent or active) that, in the investigator's opinion, could be exacerbated by study medication

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3843746 (Other major illness or surgery)
LOINC
LA14310-9
22. cd4+ t-cell count (absolute cd3+cd4+) <lower limit of normal (lln) at screening
Descrizione

22. cd4+ t-cell count (absolute cd3+cd4+) <lower limit of normal (lln) at screening

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1855068 (Low CD4+ count)
23. cd8+ t-cell count (absolute cd3+cd8+) <lln at screening
Descrizione

23. cd8+ t-cell count (absolute cd3+cd8+) <lln at screening

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3810110 (Decreased CD8+ T cells)
24. b-cell count (absolute cd19+) <lln at screening
Descrizione

24. b-cell count (absolute cd19+) <lln at screening

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C3540683 (CD19 Expressing Cell Count)
UMLS CUI [1,2]
C0205216 (Decreased)
SNOMED
1250004
25. absolute neutrophil count <lln at screening
Descrizione

25. absolute neutrophil count <lln at screening

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1168174 (Absolute neutrophil count decreased)
26. confirmed platelet count < the lln of the evaluating laboratory at screening or documented at <100,000/μl within the past year on a sample without platelet clumping
Descrizione

26. confirmed platelet count < the lln of the evaluating laboratory at screening or documented at <100,000/μl within the past year on a sample without platelet clumping

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0040034 (Thrombocytopenia)
SNOMED
302215000
27. presence (i.e., above the uln) of anti-thyroid stimulating hormone receptor antibodies (anti-tshr) and anti-thyroid peroxidase antibody (anti-tpo)
Descrizione

27. presence (i.e., above the uln) of anti-thyroid stimulating hormone receptor antibodies (anti-tshr) and anti-thyroid peroxidase antibody (anti-tpo)

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0370061 (Anti-thyrotropin antibody)
SNOMED
121126007
LOINC
LP40004-1
UMLS CUI [1,2]
C0076635 (Thyroid microsomal antibodies)
SNOMED
103184005
28. any hepatic or renal function value grade 2 or higher at screening, with the exception of hyperbilirubinemia due to gilbert's syndrome. see table below, drawn from the national cancer institute (nci) common terminology criteria for adverse events v4.0 (ctcae), published 28 may 2009.
Descrizione

28. any hepatic or renal function value grade 2 or higher at screening, with the exception of hyperbilirubinemia due to gilbert's syndrome. see table below, drawn from the national cancer institute (nci) common terminology criteria for adverse events v4.0 (ctcae), published 28 may 2009.

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0151746 (Abnormal renal function)
SNOMED
39539005
UMLS CUI [2,1]
C0086565 (Liver Dysfunction)
SNOMED
75183008
bilirubin >1.5 × uln
Descrizione

bilirubin >1.5 × uln

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0201913 (Bilirubin, total measurement)
SNOMED
359986008
sgot/ast >3.0 × uln
Descrizione

sgot/ast >3.0 × uln

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0201899 (Aspartate aminotransferase measurement)
SNOMED
45896001
sgpt/alt >3.0 × uln
Descrizione

sgpt/alt >3.0 × uln

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0201836 (Alanine aminotransferase measurement)
SNOMED
34608000
alkaline phosphatase >2.5 × uln
Descrizione

alkaline phosphatase >2.5 × uln

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0201850 (Alkaline phosphatase measurement)
SNOMED
88810008
creatinine > 1.5 × uln
Descrizione

creatinine > 1.5 × uln

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0201976 (Creatinine measurement, serum (procedure))
SNOMED
113075003
29. vaccination less than 6 weeks prior to study inclusion.
Descrizione

29. vaccination less than 6 weeks prior to study inclusion.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0042196 (Vaccination)
SNOMED
33879002
LOINC
LP29692-8
30. treatment with antineoplastic or immunosuppressive drugs within 8 weeks prior to study inclusion
Descrizione

30. treatment with antineoplastic or immunosuppressive drugs within 8 weeks prior to study inclusion

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0003392 (Antineoplastic Agents)
SNOMED
27867009
UMLS CUI [2,1]
C0499076 (Immunosuppressive drug, not otherwise classified)
31. intolerance of pulsed corticosteroids, especially a history of steroid psychosis
Descrizione

31. intolerance of pulsed corticosteroids, especially a history of steroid psychosis

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0749014 (STEROID INTOLERANCE)
32. inability to undergo mri with gadolinium administration
Descrizione

32. inability to undergo mri with gadolinium administration

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0024485 (Magnetic Resonance Imaging)
SNOMED
312250003
LOINC
LP57602-2
33. of childbearing potential with a positive serum pregnancy test, pregnant or lactating
Descrizione

33. of childbearing potential with a positive serum pregnancy test, pregnant or lactating

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0549206 (Patient currently pregnant)
SNOMED
77386006
LOINC
LA14670-6
UMLS CUI [2]
C2828358 (Lactating (finding))
34. female patients of childbearing potential: unwilling to agree to use a reliable and acceptable contraceptive method (pearl index <1) throughout the study period. these methods include: hormone releasing intrauterine device (iud), hormonal-based contraception, surgical sterilization, abstinence, or double-barrier contraception (condom and occlusive cap [diaphragm or cervical cap combined with spermicide]).
Descrizione

34. female patients of childbearing potential: unwilling to agree to use a reliable and acceptable contraceptive method (pearl index <1) throughout the study period. these methods include: hormone releasing intrauterine device (iud), hormonal-based contraception, surgical sterilization, abstinence, or double-barrier contraception (condom and occlusive cap [diaphragm or cervical cap combined with spermicide]).

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0700589 (Contraceptive methods)
SNOMED
13197004
Ritorna all'inizio della pagina

Similar models

Eligibility Multiple Sclerosis, Relapsing-Remitting NCT02419378

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
signed informed consent
Item
1. signed informed consent form (icf)
boolean
C0021430 (UMLS CUI [1])
age
Item
2. age 18 to 55 years old (inclusive) as of the date the icf is signed
boolean
C0001779 (UMLS CUI [1])
Multiple Sclerosis; McDonald criteria and MRI Scan
Item
3. diagnosis of ms according to the mcdonald criteria 2010 and cranial mri scan demonstrating white matter lesions attributable to ms within 5 years before screening
boolean
C0026769 (UMLS CUI [1,1])
C0917711 (UMLS CUI [1,2])
Onset of symptoms within 5 years
Item
4. onset of ms symptoms (as determined by a neurologist, either at present or retrospectively) within 5 years of the date the icf is signed
boolean
C1457887 (UMLS CUI [1,1])
C0332162 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
EDSS score
Item
5. edss score 0.0 to 4.0 (inclusive) at screening
boolean
C0451246 (UMLS CUI [1])
Active disease
Item
6. ≥2 ms relapses within 24 months or clinical (≥1 relapse) or mri (new gadolinium enhancing lesions) disease activity under therapy with interferon beta, glatirameracetate, natalizumab or fingolimod
boolean
C2707252 (UMLS CUI [1])
Medical Judgment
Item
7. indicated to receive alemtuzumab according to the investigator's assessment
boolean
C1548948 (UMLS CUI [1,1])
Vaccinations
Item
8. completion of all vaccinations required by the applicable immunization guidelines published by "ständige impfkommission" (stiko)
boolean
C0042196 (UMLS CUI [1])
Chickenpox; VZV
Item
9. history of chickenpox or positive test for antibodies against varicella zoster virus (vzv)
boolean
C0008049 (UMLS CUI [1,1])
C0042338 (UMLS CUI [2])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Other trial
Item
1. participation in another clinical trial at present or within 4 weeks of study entry. there may be exceptions at the discretion of the investigator.
boolean
C2348568 (UMLS CUI [1])
Progressive Multiple Sclerosis
Item
2. has any progressive form of ms
boolean
C1095979 (UMLS CUI [1])
Hypersensitivity to active substance
Item
3. hypersensitivity to the active substance, or to any of the excipients of lemtrada
boolean
C0020517 (UMLS CUI [1,1])
C1372955 (UMLS CUI [1,2])
Informed Consent | Protocol Compliance
Item
4. medical, psychiatric, cognitive, or other conditions that, in the investigator's opinion, compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study
boolean
C0021430 (UMLS CUI [1,1])
C0525058 (UMLS CUI [2,1])
Disability
Item
5. any disability acquired from trauma or another illness that could interfere with evaluation of disability due to ms
boolean
C0231170 (UMLS CUI [1])
Major disease
Item
6. major systemic disease or other illness that would, in the opinion of the investigator, compromise patient safety or interfere with the interpretation of study results, e.g., current peptic ulcer disease or other conditions that may predispose to hemorrhage
boolean
C0442893 (UMLS CUI [1])
Bleeding disorder
Item
7. known bleeding disorder (e.g,. dysfibrinogenemia, factor ix deficiency, hemophilia, von willebrand's disease, disseminated intravascular coagulation (dic), fibrinogen deficiency, or clotting factor deficiency)
boolean
C3251812 (UMLS CUI [1])
Autoimmune Diseases
Item
8. significant autoimmune disease including but not limited to immune cytopenias, rheumatoid arthritis, systemic lupus erythematosus, other connective tissue disorders, vasculitis, inflammatory bowel disease, severe psoriasis
boolean
C0004364 (UMLS CUI [1,1])
malignancy, except basal skin cell carcinoma
Item
9. history of malignancy, except basal skin cell carcinoma
boolean
C0006826 (UMLS CUI [1])
Psychiatric disorder, uncontrolled
Item
10. major psychiatric disorder that is not adequately controlled by treatment
boolean
C0004936 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Seizures, uncontrolled
Item
11. epileptic seizures that are not adequately controlled by treatment
boolean
C0036572 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Active infection
Item
12. active infection, e.g., deep-tissue infection, that the investigator considers sufficiently serious to preclude study participation
boolean
C0009450 (UMLS CUI [1])
high risk of infection
Item
13. in the investigator's opinion, is at high risk for infection (e.g., indwelling catheter, dysphagia with aspiration, decubitus ulcer, history of prior aspiration pneumonia or recurrent urinary tract infection)
boolean
C0582147 (UMLS CUI [1,1])
HIV positive
Item
14. seropositivity for human immunodeficiency virus (hiv)
boolean
C0019699 (UMLS CUI [1])
Hepatitis C
Item
15. infection with hepatitis c virus
boolean
C0019196 (UMLS CUI [1])
hepatitis b
Item
16. past or present hepatitis b infection (positive hepatitis b serology)
boolean
C0019163 (UMLS CUI [1])
CMV | EBV | VZV infection
Item
17. active infection with human cytomegaly virus (hcmv), epstein-barr virus (ebv), varicella-zoster virus (vzv)
boolean
C0010825 (UMLS CUI [1])
C0014644 (UMLS CUI [2])
C0042338 (UMLS CUI [3])
Tuberculosis
Item
18. latent tuberculosis unless effective anti-tuberculosis therapy has been completed, or active tuberculosis.
boolean
C0041296 (UMLS CUI [1])
Fungal infection
Item
19. invasive fungal infections in history and at present
boolean
C0026946 (UMLS CUI [1])
Cervical cytology
Item
20. cervical cytology other than pap I or pap II (papanicolaou) or cervical high risk human papillomavirus (hpv) positivity
boolean
C0856201 (UMLS CUI [1,1])
other illness
Item
21. any other illness or infection (latent or active) that, in the investigator's opinion, could be exacerbated by study medication
boolean
C3843746 (UMLS CUI [1])
CD4+ low
Item
22. cd4+ t-cell count (absolute cd3+cd4+) <lower limit of normal (lln) at screening
boolean
C1855068 (UMLS CUI [1])
CD8+ low
Item
23. cd8+ t-cell count (absolute cd3+cd8+) <lln at screening
boolean
C3810110 (UMLS CUI [1])
CD19+ low
Item
24. b-cell count (absolute cd19+) <lln at screening
boolean
C3540683 (UMLS CUI [1,1])
C0205216 (UMLS CUI [1,2])
ANC low
Item
25. absolute neutrophil count <lln at screening
boolean
C1168174 (UMLS CUI [1])
Thrombopenia
Item
26. confirmed platelet count < the lln of the evaluating laboratory at screening or documented at <100,000/μl within the past year on a sample without platelet clumping
boolean
C0040034 (UMLS CUI [1])
Anti-thyrotropin antibody | Thyroid peroxidase antibody
Item
27. presence (i.e., above the uln) of anti-thyroid stimulating hormone receptor antibodies (anti-tshr) and anti-thyroid peroxidase antibody (anti-tpo)
boolean
C0370061 (UMLS CUI [1,1])
C0076635 (UMLS CUI [1,2])
Abnormal renal function | abnormal hepatic function
Item
28. any hepatic or renal function value grade 2 or higher at screening, with the exception of hyperbilirubinemia due to gilbert's syndrome. see table below, drawn from the national cancer institute (nci) common terminology criteria for adverse events v4.0 (ctcae), published 28 may 2009.
boolean
C0151746 (UMLS CUI [1,1])
C0086565 (UMLS CUI [2,1])
Bilirubin, total
Item
bilirubin >1.5 × uln
boolean
C0201913 (UMLS CUI [1])
AST
Item
sgot/ast >3.0 × uln
boolean
C0201899 (UMLS CUI [1])
ALT
Item
sgpt/alt >3.0 × uln
boolean
C0201836 (UMLS CUI [1])
Alkaline phosphatase
Item
alkaline phosphatase >2.5 × uln
boolean
C0201850 (UMLS CUI [1])
Creatinine
Item
creatinine > 1.5 × uln
boolean
C0201976 (UMLS CUI [1])
vaccination
Item
29. vaccination less than 6 weeks prior to study inclusion.
boolean
C0042196 (UMLS CUI [1])
Antineoplastic drug | Immunosuppressive drug
Item
30. treatment with antineoplastic or immunosuppressive drugs within 8 weeks prior to study inclusion
boolean
C0003392 (UMLS CUI [1,1])
C0499076 (UMLS CUI [2,1])
Steroid intolerance
Item
31. intolerance of pulsed corticosteroids, especially a history of steroid psychosis
boolean
C0749014 (UMLS CUI [1,1])
MRI
Item
32. inability to undergo mri with gadolinium administration
boolean
C0024485 (UMLS CUI [1])
pregnant | lactating
Item
33. of childbearing potential with a positive serum pregnancy test, pregnant or lactating
boolean
C0549206 (UMLS CUI [1])
C2828358 (UMLS CUI [2])
Contraception
Item
34. female patients of childbearing potential: unwilling to agree to use a reliable and acceptable contraceptive method (pearl index <1) throughout the study period. these methods include: hormone releasing intrauterine device (iud), hormonal-based contraception, surgical sterilization, abstinence, or double-barrier contraception (condom and occlusive cap [diaphragm or cervical cap combined with spermicide]).
boolean
C0700589 (UMLS CUI [1,1])
Ritorna all'inizio della pagina 

Aiuto

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial