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Fehler:
ID
44517
Beschreibung
Study part: Screening Visite/ Run-In- Phase (Visite 1/ Woche -4). TMP001 in Relapsing-remitting Multiple Sclerosis: A Multicentre Open, Baseline-controlled Phase IIa Clinical Trial.
Stichworte
Versionen (2)
- 19.11.17 19.11.17 -
- 27.09.21 27.09.21 -
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SocraMetrics
Hochgeladen am
27. September 2021
DOI
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Creative Commons BY-NC 3.0
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Screening Visite/ Run-In- Phase (Visite 1/ Woche -4) TMP001 Multiple Sclerosis NCT02686788
Screening Visite/ Run-In- Phase (Visite 1/ Woche -4)
- StudyEvent: ODM
Ähnliche Modelle
Screening Visite/ Run-In- Phase (Visite 1/ Woche -4)
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Patient ID
Item
Patientennummer:
text
C2348585 (UMLS CUI [1])
Informed Consent Date
Item
Datum der Unterzeichnung der Einwilligungserklärung durch den Patienten
date
C2985782 (UMLS CUI [1])
Patient ID
Item
Der Patient erhält die folgende Patientennummer
text
C2348585 (UMLS CUI [1])
Date of visit screening
Item
Datum der Screening Visite
date
C1320303 (UMLS CUI [1,1])
C1710477 (UMLS CUI [1,2])
C1710477 (UMLS CUI [1,2])
Age
Item
Alter
integer
C0001779 (UMLS CUI [1])
CL Item
männlich (1)
CL Item
weiblich (2)
Height
Item
Größe
float
C0005890 (UMLS CUI [1])
Weight
Item
Gewicht
float
C0005910 (UMLS CUI [1])
CL Item
kaukasisch (kaukasisch)
CL Item
afrikanisch (afrikanisch)
CL Item
afro-amerikanisch (afro-amerikanisch)
CL Item
asiatisch (asiatisch)
CL Item
andere (andere)
childbearing potential
Item
Ist die Patientin gebärfahig?
boolean
C3831118 (UMLS CUI [1])
Item Group
Messung der Vitalparameter und der Körpertemperatur
C0518766 (UMLS CUI-1)
C0005903 (UMLS CUI-3)
C0005903 (UMLS CUI-3)
Systolic blood pressure
Item
Systolischer Blutdruck
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolischer Blutdruck
integer
C0428883 (UMLS CUI [1])
Pulse
Item
Puls
integer
C0232117 (UMLS CUI [1])
Body temperature
Item
Körpertemperatur
float
C0005903 (UMLS CUI [1])
Date of diagnosis Multiple Sclerosis, Acute Relapsing
Item
Seit wann leidet der Patient an schubformig remittierender Multipler Sklerose? Datum der Diagnose
date
C2316983 (UMLS CUI [1,1])
C0393664 (UMLS CUI [1,2])
C0393664 (UMLS CUI [1,2])
medical history; Comorbidity
Item
Begleiterkrankungen und sonstige Krankengeschichte (inkl. Operationen)
text
C0262926 (UMLS CUI [1])
C0009488 (UMLS CUI [2])
C0009488 (UMLS CUI [2])
Concomitant medication
Item
Begleitmedikation
text
C2347852 (UMLS CUI [1])
CL Item
normal (normal)
CL Item
abnormal (abnormal)
Specification
Item
Spezifizierung (falls abnormal)
text
C2348235 (UMLS CUI [1])
Relevance
Item
Klinisch relevant?
boolean
C2347946 (UMLS CUI [1])
CL Item
normal (normal)
CL Item
abnormal (abnormal)
Specification
Item
Spezifizierung (falls abnormal)
text
C2348235 (UMLS CUI [1])
Relevance
Item
Klinisch relevant?
boolean
C2347946 (UMLS CUI [1])
CL Item
normal (normal)
CL Item
abnormal (abnormal)
Specification
Item
Spezifizierung (falls abnormal)
text
C2348235 (UMLS CUI [1])
Relevance
Item
Klinisch relevant?
boolean
C2347946 (UMLS CUI [1])
CL Item
normal (normal)
CL Item
abnormal (abnormal)
Specification
Item
Spezifizierung (falls abnormal)
text
C2348235 (UMLS CUI [1])
Relevance
Item
Klinisch relevant?
boolean
C2347946 (UMLS CUI [1])
CL Item
normal (normal)
CL Item
abnormal (abnormal)
Specification
Item
Spezifizierung (falls abnormal)
text
C2348235 (UMLS CUI [1])
Relevance
Item
Klinisch relevant?
boolean
C2347946 (UMLS CUI [1])
CL Item
normal (normal)
CL Item
abnormal (abnormal)
Specification
Item
Spezifizierung (falls abnormal)
text
C2348235 (UMLS CUI [1])
Relevance
Item
Klinisch relevant?
boolean
C2347946 (UMLS CUI [1])
CL Item
normal (normal)
CL Item
abnormal (abnormal)
Specification
Item
Spezifizierung (falls abnormal)
text
C2348235 (UMLS CUI [1])
Relevance
Item
Klinisch relevant?
boolean
C2347946 (UMLS CUI [1])
CL Item
normal (normal)
CL Item
abnormal (abnormal)
Specification
Item
Spezifizierung (falls abnormal)
text
C2348235 (UMLS CUI [1])
Relevance
Item
Klinisch relevant?
boolean
C2347946 (UMLS CUI [1])
CL Item
normal (normal)
CL Item
abnormal (abnormal)
Specification
Item
Spezifizierung (falls abnormal)
text
C2348235 (UMLS CUI [1])
Relevance
Item
Klinisch relevant?
boolean
C2347946 (UMLS CUI [1])
CL Item
normal (normal)
CL Item
abnormal (abnormal)
Specification
Item
Spezifizierung (falls abnormal)
text
C2348235 (UMLS CUI [1])
Relevance
Item
Klinisch relevant?
boolean
C2347946 (UMLS CUI [1])
Urine pH
Item
pH
text
C0042044 (UMLS CUI [1])
CL Item
negativ (negativ)
CL Item
positiv (positiv)
CL Item
abnormal, nicht klinisch signifikant (abnormal, nicht klinisch signifikant)
CL Item
abnormal, klinisch signifikant (abnormal, klinisch signifikant)
CL Item
negativ (negativ)
CL Item
positiv (positiv)
CL Item
abnormal, nicht klinisch signifikant (abnormal, nicht klinisch signifikant)
CL Item
abnormal, klinisch signifikant (abnormal, klinisch signifikant)
CL Item
negativ (negativ)
CL Item
positiv (positiv)
CL Item
abnormal, nicht klinisch signifikant (abnormal, nicht klinisch signifikant)
CL Item
abnormal, klinisch signifikant (abnormal, klinisch signifikant)
CL Item
negativ (negativ)
CL Item
positiv (positiv)
CL Item
abnormal, nicht klinisch signifikant (abnormal, nicht klinisch signifikant)
CL Item
abnormal, klinisch signifikant (abnormal, klinisch signifikant)
CL Item
negativ (negativ)
CL Item
positiv (positiv)
CL Item
abnormal, nicht klinisch signifikant (abnormal, nicht klinisch signifikant)
CL Item
abnormal, klinisch signifikant (abnormal, klinisch signifikant)
CL Item
negativ (negativ)
CL Item
positiv (positiv)
CL Item
abnormal, nicht klinisch signifikant (abnormal, nicht klinisch signifikant)
CL Item
abnormal, klinisch signifikant (abnormal, klinisch signifikant)
CL Item
negativ (negativ)
CL Item
positiv (positiv)
CL Item
abnormal, nicht klinisch signifikant (abnormal, nicht klinisch signifikant)
CL Item
abnormal, klinisch signifikant (abnormal, klinisch signifikant)
CL Item
negativ (negativ)
CL Item
positiv (positiv)
CL Item
abnormal, nicht klinisch signifikant (abnormal, nicht klinisch signifikant)
CL Item
abnormal, klinisch signifikant (abnormal, klinisch signifikant)
CL Item
negativ (negativ)
CL Item
positiv (positiv)
CL Item
nicht zutreffend (falls Patientin nicht gebarfahig oder mannlicher Patient) (nicht zutreffend (falls Patientin nicht gebarfahig oder mannlicher Patient))
Item Group
Lokale Laboruntersuchungen (Klinische Chemie, Hämatologie, Gerinnung, Serologie)
C0022877 (UMLS CUI-1)
date blood sampling
Item
Datum der Blutentnahme
date
C1264639 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,2])
Laboratory result
Item
Gab es klinisch signifikante Laborparameter außerhalb der Norm?
boolean
C0587081 (UMLS CUI [1])
Laboratory result; Medical history
Item
Falls ja, passen die abnormalen Laborparameter zur Krankengeschichte des Patienten?
boolean
C0587081 (UMLS CUI [1])
C0262926 (UMLS CUI [2])
C0262926 (UMLS CUI [2])
Date blood sampling
Item
Datum der Blutentnahme
date
C1264639 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,2])
Time blood sampling
Item
Uhrzeit der Blutentnahme
time
C0040223 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,2])
Item Group
Neurologische Scores (Funktionelle Systeme und Expanded Disability Status Skala nach Kurtzke)
C3887783 (UMLS CUI-1)
Pyramidal Tracts; Paralysed
Item
1. Pyramidenbahn (z.B. Lähmungen) Grad
integer
C0034229 (UMLS CUI [1])
C0522224 (UMLS CUI [2])
C0522224 (UMLS CUI [2])
Cerebellum; Cerebellar Ataxia
Item
2. Kleinhirn (z.B. Atexie, Tremor) Grad
integer
C0007765 (UMLS CUI [1])
C0007758 (UMLS CUI [2])
C0007758 (UMLS CUI [2])
Brain Stem; Speech Disorders; Deglutition Disorders
Item
3. Hirnstamm (z.B. Sprach-/ Schluckstörungen) Grad
integer
C0006121 (UMLS CUI [1])
C0037822 (UMLS CUI [2])
C0011168 (UMLS CUI [3])
C0037822 (UMLS CUI [2])
C0011168 (UMLS CUI [3])
Sensory; Hypesthesia
Item
4. Sensorium (z.B. Verminderung des Berührungssinns) Grad
integer
C0445254 (UMLS CUI [1])
C0020580 (UMLS CUI [2])
C0020580 (UMLS CUI [2])
Urinary Bladder; Urinary Incontinence; Rectum
Item
5. Blasen- und Mastdarmfunktionen (z.B. Urininkontinenz) Grad
integer
C0005682 (UMLS CUI [1])
C0042024 (UMLS CUI [2])
C0034896 (UMLS CUI [3])
C0042024 (UMLS CUI [2])
C0034896 (UMLS CUI [3])
visual acuity; Scotoma
Item
6. Sehfunktionen (z.B. eingeschränktes Gesichtsfeld- Skotom) Grad
integer
C0042812 (UMLS CUI [1])
C0036454 (UMLS CUI [2])
C0036454 (UMLS CUI [2])
Cerebral hemisphere structure; Behavioral change; Dementia
Item
7. Zerebrale Funktionen (z.B. Wesensveränderung, Demenz) Grad
integer
C0228174 (UMLS CUI [1])
C0542299 (UMLS CUI [2])
C0497327 (UMLS CUI [3])
C0542299 (UMLS CUI [2])
C0497327 (UMLS CUI [3])
Expanded Disability Status Scale
Item
Grad der EDSS
integer
C0451246 (UMLS CUI [1])
date MRT
Item
Datum des MRT- Scans
date
C0011008 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,2])
age
Item
Age 18 to 55 years
boolean
C0001779 (UMLS CUI [1])
Relapsing-Remitting Multiple Sclerosis
Item
Definite diagnosis of RRMS (according to revised McDonald criteria, Polman et al. 2011, Ann Neurol 69:292-302)
boolean
C0751967 (UMLS CUI [1])
MS relapse
Item
At least 1 documented relapse during the previous year OR at least 2 documented relapses during the previous 2 years
boolean
C0856120 (UMLS CUI [1])
Enhancing Lesion MRI
Item
At least one contrast-enhancing lesion (CEL) on the screening MRI scan at week (-4)
boolean
C3830314 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,2])
EDSS
Item
EDSS of 0 - 5 (inclusive) at screening (week -4)
boolean
C0451246 (UMLS CUI [1])
childbearing potential; contraception
Item
Women of childbearing potential (WOCBP) must use 2 adequate forms of contraception to avoid pregnancy throughout the trial (such as a double barrier method) and for up to 8 weeks after the last dose of TMPO01 in such a manner that the risk of pregnancy is minimized
boolean
C3831118 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
C0700589 (UMLS CUI [2])
informed consent
Item
Written informed consent obtained prior to the initiation of any protocol-required procedures
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
Compliance to study procedure and study protocol
boolean
C0525058 (UMLS CUI [1])
immunodeficiency syndrome
Item
History of chronic disease of the immune system other than MS or a known immunodeficiency syndrome
boolean
C0021051 (UMLS CUI [1])
infection active; pneumonia
Item
Clinically severe active infection (e.g. pneumonia, septicaemia) within the 1 month prior to Screening
boolean
C3714514 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0032285 (UMLS CUI [2])
C0205177 (UMLS CUI [1,2])
C0032285 (UMLS CUI [2])
neuromyelitis optica; Clinically isolated syndrome; secondary progressive multiple sclerosis; primary progressive multiple sclerosis
Item
Diagnosis of neuromyelitis optica, clinically isolated syndrome, secondary progressive multiple sclerosis, or primary progressive multiple sclerosis
boolean
C0027873 (UMLS CUI [1])
C2921627 (UMLS CUI [2])
C0751965 (UMLS CUI [3])
C0751964 (UMLS CUI [4])
C2921627 (UMLS CUI [2])
C0751965 (UMLS CUI [3])
C0751964 (UMLS CUI [4])
Substance abuse disorders
Item
History of drug or alcohol abuse within 2 years of inclusion to the study
boolean
C0038586 (UMLS CUI [1])
MS relapse; corticosteroid treatment
Item
Relapse or corticosteroid treatment within 30 days before screening (week -4)
boolean
C0856120 (UMLS CUI [1])
C0149783 (UMLS CUI [2])
C0149783 (UMLS CUI [2])
Therapy Interferon-beta glatiramer acetate teriflunomide dimethyl fumarate fingolimod
Item
Interferon-beta, glatiramer acetate, teriflunomide, dimethyl fumarate or fingolimod therapy had to have been stopped 3 or more months before enrolment
boolean
C0087111 (UMLS CUI [1,1])
C0015980 (UMLS CUI [1,2])
C0289884 (UMLS CUI [1,3])
C1718383 (UMLS CUI [1,4])
C0058218 (UMLS CUI [1,5])
C1699926 (UMLS CUI [1,6])
C0015980 (UMLS CUI [1,2])
C0289884 (UMLS CUI [1,3])
C1718383 (UMLS CUI [1,4])
C0058218 (UMLS CUI [1,5])
C1699926 (UMLS CUI [1,6])
Therapeutic immunosuppression azathioprine methotrexate
Item
lmmunosuppressive medication such as azathioprine or methotrexate, Ciclosporin, cyclophosphamide, mycophenolate mofetil, mitoxantrone or cladribine at any time
boolean
C0021079 (UMLS CUI [1,1])
C0004482 (UMLS CUI [1,2])
C0025677 (UMLS CUI [1,3])
C0004482 (UMLS CUI [1,2])
C0025677 (UMLS CUI [1,3])
Therapy alemtuzumab; body irradiation; bone marrow transplantation
Item
Any previous therapy with alemtuzumab, ocrelizumab, ofatumumab, rituximab, belimumab, natalizumab, total body irradiation, or bone marrow transplantation
boolean
C0087111 (UMLS CUI [1,1])
C0383429 (UMLS CUI [1,2])
C0043162 (UMLS CUI [2])
C0005961 (UMLS CUI [3])
C0383429 (UMLS CUI [1,2])
C0043162 (UMLS CUI [2])
C0005961 (UMLS CUI [3])
investigational drug; placebo
Item
Any investigational drug or placebo within 12 weeks prior to enrolment OR > 5 half-lives prior to screening (week -4), whichever is longer
boolean
C0013230 (UMLS CUI [1])
C0032042 (UMLS CUI [2])
C0032042 (UMLS CUI [2])
Pregnancy; lactating
Item
Women that are pregnant or currently breast feeding
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
C0006147 (UMLS CUI [1,2])
Study subject participation status
Item
Concurrent participation in other clinical trials
boolean
C2348568 (UMLS CUI [1])
comorbidity malignancy
Item
History of, or current diagnosis of, malignancy (including previously treated skin cancer other than successfully treated basal and squamous skin cancer with no evidence of recurrence within 5 years)
boolean
C0009488 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,2])
contraindication MRI
Item
Inability to complete an MRI or contraindications for MRI, including but not limited to claustrophobia, presence of a pacemaker, cochlear implants, ferromagnetic devices or clips, intracranial vascular clips, insulin pumps, or nerve stimulators
boolean
C0522473 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,2])
Hypersensitivity contrast agent
Item
Hypersensitivity to contrast agent (Gadolinium, resp. Gadopentetat-Dimeglumin)
boolean
C0020517 (UMLS CUI [1,1])
C0009924 (UMLS CUI [1,2])
C0009924 (UMLS CUI [1,2])
Study Subject Participation Status
Item
Any reason in the discretion of the investigator regarding the safe participation of the patient in the study or for any other reason, the investigator considers the patient inappropriate for participation in the study
boolean
C2348568 (UMLS CUI [1])
White blood count
Item
White blood count (WBC) < 3000 mm^3 at screening (week -4)
boolean
C0023508 (UMLS CUI [1])
Lymphocytes
Item
Lymphocytes < 800 mm^3 at screening (week -4)
boolean
C0200635 (UMLS CUI [1])
renal insufficiency stage
Item
Known renal insufficiency stage lll or higher (eGFR <= 59ml/min/1.73m^2; according to the Kidney Disease Outcomes Quality Initiative (KDOQl))
boolean
C1565489 (UMLS CUI [1])
hypersensitivity study medication
Item
Patients with known hypersensitivity to study medication
boolean
C0020517 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
hypersensitivity NSAlDs
Item
Patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other non-steroidal anti-inflammatory drugs (NSAlDs)
boolean
C0020517 (UMLS CUI [1,1])
C0003211 (UMLS CUI [1,2])
C0003211 (UMLS CUI [1,2])
peptic ulcer disease; gastrointestinal bleeding
Item
Patients with a history of peptic ulcer disease and/or gastrointestinal bleeding
boolean
C0030920 (UMLS CUI [1])
C0017181 (UMLS CUI [2])
C0017181 (UMLS CUI [2])
Renal disorder; Hepatic disorder; metabolic disorder
Item
Chronic or acute renal, hepatic or metabolic disorder
boolean
C0022658 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0025517 (UMLS CUI [3])
C0023895 (UMLS CUI [2])
C0025517 (UMLS CUI [3])
myocardial infarction; ischemic stroke; heart failure
Item
Patients with a history of my myocardial infarction, ischemic stroke or known heart failure
boolean
C0027051 (UMLS CUI [1])
C0948008 (UMLS CUI [2])
C0018801 (UMLS CUI [3])
C0948008 (UMLS CUI [2])
C0018801 (UMLS CUI [3])
thrombophilia; Blood Coagulation Disorders
Item
Patients with known thrombophilia or abnormal clinically significant coagulation parameter at screening (week -4)
boolean
C0398623 (UMLS CUI [1])
C0005779 (UMLS CUI [2])
C0005779 (UMLS CUI [2])
inclusion; exclusion criteria
Item
Wurde der Patient nach eingehender Prtifung aller Einschluss- und Ausschlusskriterien in die Studie eingeschlossen?
boolean
C1512693 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
C0680251 (UMLS CUI [1,2])
date inclusion
Item
Datum des Einschlusses des Patienten in die Studie
boolean
C0011008 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,2])
documentation complete
Item
Alle Visitendaten wurden korrekt und vollstandig in den CRF eingetragen. Alle relevanten Abweichungen wurden dokumentiert.
boolean
C0920316 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,2])
date
Item
Datum
date
C0011008 (UMLS CUI [1])
Investigator Signature
Item
Unterschrift Prtüfarzt
text
C2346576 (UMLS CUI [1])