Graft-versus-Host-Disease
Item
1. Acute skin, intestinal or liver GvHD > grade 1 according to standard criteria
boolean
C0018133 (UMLS CUI [1])
Histological Confirmation
Item
2. Histological confirmation in case of acute intestinal GvHD
boolean
C0449575 (UMLS CUI [1])
Age
Item
3. Age ≥18 years
boolean
C0001779 (UMLS CUI [1])
Treatment Failure
Item
4. Failure of previous treatment, defined as presence of at least one of the following criteria: 1. Treatment with prednisone/prednisolone/methylprednisolone in a dose of at least 2 mg/kg and lack of response after at least 7 days treatment 2. Treatment with prednisone/prednisolone/methylprednisolone in a dose of at least 2 mg/kg and progression after at least 3 days of treatment 3. Failure to taper the prednisone/prednisolone dose to 0.6 mg/kg/day or methylpredniso-lone dose to <0.5 mg/kg/day
boolean
C0162643 (UMLS CUI [1])
Informed Consent
Item
5. Written informed consent
boolean
C0021430 (UMLS CUI [1])
Understanding Ability
Item
6. Ability to understand the nature of the study and the study related procedures and to comply with them
boolean
C0582778 (UMLS CUI [1])
Control Group
Item
0. Healthy Volunteers
boolean
C0009932 (UMLS CUI [1])
Comorbidity
Item
1. Uncontrolled underlying disease
boolean
Bleeding Disorder
Item
2. Active bleeding
boolean
C0005779 (UMLS CUI [1])
Asymptomatic
Item
3. Absence of clinical signs of acute GvHD
boolean
C0231221 (UMLS CUI [1])
Chronic Graft-versus-Host-Disease
Item
4. Diagnostic or distinctive clinical signs of chronic GvHD
boolean
C0867389 (UMLS CUI [1])
Infection
Item
5. Uncontrolled bacterial, viral or fungal infection
boolean
C0009450 (UMLS CUI [1])
JAK2 inhibitor
Item
6. Any previous JAK2 inhibitor treatment prior to study enrolment, except Ruxolitinib given prior to the allogeneic stem cell transplantati
boolean
C4086530 (UMLS CUI [1])
Hypersensitivity to Ruxolitinib
Item
7. Known Hypersensitivity to Ruxolitinib or any of the excipients
boolean
C0020517 (UMLS CUI [1,1])
C2931926 (UMLS CUI [1,2])
HIV, HBV, HCV
Item
8. Known positivity for HIV, Hepatitis B or Hepatitis C at the time of screening.
boolean
C0019699 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
C1112419 (UMLS CUI [3])
Gynaecological Status
Item
9. Female patients who are pregnant or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Experimental Drug
Item
10. Concomitant use of any other investigational drug within the last thirty days before the start of this study
boolean
C0304229 (UMLS CUI [1])