ID

44517

Description

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.

Keywords

Versions (2)
  1. 11/19/17 11/19/17 -
  2. 9/27/21 9/27/21 -
Copyright Holder

SocraMetrics

Uploaded on

September 27, 2021

DOI

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License

Creative Commons BY-NC 3.0
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Screening Visite/ Run-In- Phase (Visite 1/ Woche -4) TMP001 Multiple Sclerosis NCT02686788

German

Screening Visite/ Run-In- Phase (Visite 1/ Woche -4)

1 forms  
Verwaltungsdokumentation
Description

Verwaltungsdokumentation

Alias
UMLS CUI-1
C1320722
Patientennummer:
Description

Patient ID

Data type

text

Alias
UMLS CUI [1]
C2348585
Datum der Unterzeichnung der Einwilligungserklärung durch den Patienten
Description

Informed Consent Date

Data type

date

Alias
UMLS CUI [1]
C2985782
Der Patient erhält die folgende Patientennummer
Description

Patient ID

Data type

text

Alias
UMLS CUI [1]
C2348585
Datum der Screening Visite
Description

Date of visit screening

Data type

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C1710477
Demographische Daten
Description

Demographische Daten

Alias
UMLS CUI-1
C0011298
Alter
Description

Age

Data type

integer

Measurement units
  • Jahre
Alias
UMLS CUI [1]
C0001779
Jahre
Geschlecht
Description

Gender

Data type

integer

Alias
UMLS CUI [1]
C0079399
Größe
Description

Height

Data type

float

Measurement units
  • m
Alias
UMLS CUI [1]
C0005890
m
Gewicht
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Ethnische Zugehörigkeit
Description

Ethnicity

Data type

text

Alias
UMLS CUI [1]
C0015031
Gebärfähigkeit
Description

Gebärfähigkeit

Alias
UMLS CUI-1
C3831118
Ist die Patientin gebärfahig?
Description

Die nachfolgende Abfrage bitte nur im Fall weiblicher Patienten ausfüllen.

Data type

boolean

Alias
UMLS CUI [1]
C3831118
Messung der Vitalparameter und der Körpertemperatur
Description

Messung der Vitalparameter und der Körpertemperatur

Alias
UMLS CUI-1
C0518766
UMLS CUI-3
C0005903
Systolischer Blutdruck
Description

Systolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolischer Blutdruck
Description

Diastolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Puls
Description

Pulse

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0232117
bpm
Körpertemperatur
Description

Body temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Krankengeschichte und Begleiterkrankungen
Description

Krankengeschichte und Begleiterkrankungen

Alias
UMLS CUI-1
C0009488
Seit wann leidet der Patient an schubformig remittierender Multipler Sklerose? Datum der Diagnose
Description

Date of diagnosis Multiple Sclerosis, Acute Relapsing

Data type

date

Alias
UMLS CUI [1,1]
C2316983
UMLS CUI [1,2]
C0393664
Begleiterkrankungen und sonstige Krankengeschichte (inkl. Operationen)
Description

medical history; Comorbidity

Data type

text

Alias
UMLS CUI [1]
C0262926
UMLS CUI [2]
C0009488
Begleitmedikation
Description

Concomitant medication

Data type

text

Alias
UMLS CUI [1]
C2347852
Körperliche Untersuchung
Description

Körperliche Untersuchung

Alias
UMLS CUI-1
C0031809
Allgemeiner Zustand
Description

General physical condition

Data type

text

Alias
UMLS CUI [1]
C1142435
Spezifizierung (falls abnormal)
Description

Specification

Data type

text

Alias
UMLS CUI [1]
C2348235
Klinisch relevant?
Description

Relevance

Data type

boolean

Alias
UMLS CUI [1]
C2347946
Haut
Description

Skin

Data type

text

Alias
UMLS CUI [1]
C1123023
Spezifizierung (falls abnormal)
Description

Specification

Data type

text

Alias
UMLS CUI [1]
C2348235
Klinisch relevant?
Description

Relevance

Data type

boolean

Alias
UMLS CUI [1]
C2347946
Augen
Description

Eye

Data type

text

Alias
UMLS CUI [1]
C0015392
Spezifizierung (falls abnormal)
Description

Specification

Data type

text

Alias
UMLS CUI [1]
C2348235
Klinisch relevant?
Description

Relevance

Data type

boolean

Alias
UMLS CUI [1]
C2347946
Ohren
Description

Ear

Data type

text

Alias
UMLS CUI [1]
C0013443
Spezifizierung (falls abnormal)
Description

Specification

Data type

text

Alias
UMLS CUI [1]
C2348235
Klinisch relevant?
Description

Relevance

Data type

boolean

Alias
UMLS CUI [1]
C2347946
Nase
Description

Nose

Data type

text

Alias
UMLS CUI [1]
C0028429
Spezifizierung (falls abnormal)
Description

Specification

Data type

text

Alias
UMLS CUI [1]
C2348235
Klinisch relevant?
Description

Relevance

Data type

boolean

Alias
UMLS CUI [1]
C2347946
Hals
Description

Throat

Data type

text

Alias
UMLS CUI [1]
C0031354
Spezifizierung (falls abnormal)
Description

Specification

Data type

text

Alias
UMLS CUI [1]
C2348235
Klinisch relevant?
Description

Relevance

Data type

boolean

Alias
UMLS CUI [1]
C2347946
Herz/ Lunge
Description

Heart; Lungs

Data type

text

Alias
UMLS CUI [1]
C0018787
UMLS CUI [2]
C0024109
Spezifizierung (falls abnormal)
Description

Specification

Data type

text

Alias
UMLS CUI [1]
C2348235
Klinisch relevant?
Description

Relevance

Data type

boolean

Alias
UMLS CUI [1]
C2347946
Abdomen
Description

Abdomen

Data type

text

Alias
UMLS CUI [1]
C0000726
Spezifizierung (falls abnormal)
Description

Specification

Data type

text

Alias
UMLS CUI [1]
C2348235
Klinisch relevant?
Description

Relevance

Data type

boolean

Alias
UMLS CUI [1]
C2347946
Lymphknoten
Description

lymph nodes

Data type

text

Alias
UMLS CUI [1]
C0024204
Spezifizierung (falls abnormal)
Description

Specification

Data type

text

Alias
UMLS CUI [1]
C2348235
Klinisch relevant?
Description

Relevance

Data type

boolean

Alias
UMLS CUI [1]
C2347946
Extremitäten
Description

extremities

Data type

text

Alias
UMLS CUI [1]
C0278454
Spezifizierung (falls abnormal)
Description

Specification

Data type

text

Alias
UMLS CUI [1]
C2348235
Klinisch relevant?
Description

Relevance

Data type

boolean

Alias
UMLS CUI [1]
C2347946
Urinanalyse
Description

Urinanalyse

Alias
UMLS CUI-1
C0042014
pH
Description

Urine pH

Data type

text

Alias
UMLS CUI [1]
C0042044
Leukozyten
Description

Leukocytes

Data type

text

Alias
UMLS CUI [1]
C0023516
Bewertung
Description

assessment

Data type

text

Alias
UMLS CUI [1]
C1516048
Nitrit
Description

Urine nitrite

Data type

text

Alias
UMLS CUI [1]
C0580333
Bewertung
Description

assessment

Data type

text

Alias
UMLS CUI [1]
C1516048
Proteine
Description

Urine protein

Data type

text

Alias
UMLS CUI [1]
C0262923
Bewertung
Description

assessment

Data type

text

Alias
UMLS CUI [1]
C1516048
Glukose
Description

Urine glucose

Data type

text

Alias
UMLS CUI [1]
C0004076
Bewertung
Description

assessment

Data type

text

Alias
UMLS CUI [1]
C1516048
Ketone
Description

Urine ketone

Data type

text

Alias
UMLS CUI [1]
C0555179
Bewertung
Description

assessment

Data type

text

Alias
UMLS CUI [1]
C1516048
Urobilinogen
Description

Urobilinogen

Data type

text

Alias
UMLS CUI [1]
C0042052
Bewertung
Description

assessment

Data type

text

Alias
UMLS CUI [1]
C1516048
Bilirubin
Description

Urine Bilirubin

Data type

text

Alias
UMLS CUI [1]
C0042040
Bewertung
Description

assessment

Data type

text

Alias
UMLS CUI [1]
C1516048
Erythrozyten
Description

Urine erythrocytes

Data type

text

Alias
UMLS CUI [1]
C2188659
Bewertung
Description

assessment

Data type

text

Alias
UMLS CUI [1]
C1516048
Ergebnis Schwangerschaftstest im Urin
Description

Urine pregnancy test

Data type

text

Alias
UMLS CUI [1]
C0430056
Lokale Laboruntersuchungen (Klinische Chemie, Hämatologie, Gerinnung, Serologie)
Description

Lokale Laboruntersuchungen (Klinische Chemie, Hämatologie, Gerinnung, Serologie)

Alias
UMLS CUI-1
C0022877
Datum der Blutentnahme
Description

date blood sampling

Data type

date

Alias
UMLS CUI [1,1]
C1264639
UMLS CUI [1,2]
C0005834
Gab es klinisch signifikante Laborparameter außerhalb der Norm?
Description

Laboratory result

Data type

boolean

Alias
UMLS CUI [1]
C0587081
Falls ja, passen die abnormalen Laborparameter zur Krankengeschichte des Patienten?
Description

Laboratory result; Medical history

Data type

boolean

Alias
UMLS CUI [1]
C0587081
UMLS CUI [2]
C0262926
Blutprobe zum Versand an Zentrallabor Frankfurt
Description

Blutprobe zum Versand an Zentrallabor Frankfurt

Alias
UMLS CUI-1
C0005834
Datum der Blutentnahme
Description

Date blood sampling

Data type

date

Alias
UMLS CUI [1,1]
C1264639
UMLS CUI [1,2]
C0005834
Uhrzeit der Blutentnahme
Description

Time blood sampling

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0005834
Neurologische Scores (Funktionelle Systeme und Expanded Disability Status Skala nach Kurtzke)
Description

Neurologische Scores (Funktionelle Systeme und Expanded Disability Status Skala nach Kurtzke)

Alias
UMLS CUI-1
C3887783
1. Pyramidenbahn (z.B. Lähmungen) Grad
Description

Pyramidal Tracts; Paralysed

Data type

integer

Alias
UMLS CUI [1]
C0034229
UMLS CUI [2]
C0522224
2. Kleinhirn (z.B. Atexie, Tremor) Grad
Description

Cerebellum; Cerebellar Ataxia

Data type

integer

Alias
UMLS CUI [1]
C0007765
UMLS CUI [2]
C0007758
3. Hirnstamm (z.B. Sprach-/ Schluckstörungen) Grad
Description

Brain Stem; Speech Disorders; Deglutition Disorders

Data type

integer

Alias
UMLS CUI [1]
C0006121
UMLS CUI [2]
C0037822
UMLS CUI [3]
C0011168
4. Sensorium (z.B. Verminderung des Berührungssinns) Grad
Description

Sensory; Hypesthesia

Data type

integer

Alias
UMLS CUI [1]
C0445254
UMLS CUI [2]
C0020580
5. Blasen- und Mastdarmfunktionen (z.B. Urininkontinenz) Grad
Description

Urinary Bladder; Urinary Incontinence; Rectum

Data type

integer

Alias
UMLS CUI [1]
C0005682
UMLS CUI [2]
C0042024
UMLS CUI [3]
C0034896
6. Sehfunktionen (z.B. eingeschränktes Gesichtsfeld- Skotom) Grad
Description

visual acuity; Scotoma

Data type

integer

Alias
UMLS CUI [1]
C0042812
UMLS CUI [2]
C0036454
7. Zerebrale Funktionen (z.B. Wesensveränderung, Demenz) Grad
Description

Cerebral hemisphere structure; Behavioral change; Dementia

Data type

integer

Alias
UMLS CUI [1]
C0228174
UMLS CUI [2]
C0542299
UMLS CUI [3]
C0497327
Grad der EDSS
Description

Expanded Disability Status Scale

Data type

integer

Alias
UMLS CUI [1]
C0451246
Datum des MRT- Scans
Description

date MRT

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0024485
Einschlusskriterien
Description

Einschlusskriterien

Alias
UMLS CUI-1
C1512693
Age 18 to 55 years
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Definite diagnosis of RRMS (according to revised McDonald criteria, Polman et al. 2011, Ann Neurol 69:292-302)
Description

Relapsing-Remitting Multiple Sclerosis

Data type

boolean

Alias
UMLS CUI [1]
C0751967
At least 1 documented relapse during the previous year OR at least 2 documented relapses during the previous 2 years
Description

MS relapse

Data type

boolean

Alias
UMLS CUI [1]
C0856120
At least one contrast-enhancing lesion (CEL) on the screening MRI scan at week (-4)
Description

Enhancing Lesion MRI

Data type

boolean

Alias
UMLS CUI [1,1]
C3830314
UMLS CUI [1,2]
C0024485
EDSS of 0 - 5 (inclusive) at screening (week -4)
Description

EDSS

Data type

boolean

Alias
UMLS CUI [1]
C0451246
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
Description

childbearing potential; contraception

Data type

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0700589
Written informed consent obtained prior to the initiation of any protocol-required procedures
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Compliance to study procedure and study protocol
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
Auschlusskriterien
Description

Auschlusskriterien

Alias
UMLS CUI-1
C0680251
History of chronic disease of the immune system other than MS or a known immunodeficiency syndrome
Description

immunodeficiency syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0021051
Clinically severe active infection (e.g. pneumonia, septicaemia) within the 1 month prior to Screening
Description

infection active; pneumonia

Data type

boolean

Alias
UMLS CUI [1,1]
C3714514
UMLS CUI [1,2]
C0205177
UMLS CUI [2]
C0032285
Diagnosis of neuromyelitis optica, clinically isolated syndrome, secondary progressive multiple sclerosis, or primary progressive multiple sclerosis
Description

neuromyelitis optica; Clinically isolated syndrome; secondary progressive multiple sclerosis; primary progressive multiple sclerosis

Data type

boolean

Alias
UMLS CUI [1]
C0027873
UMLS CUI [2]
C2921627
UMLS CUI [3]
C0751965
UMLS CUI [4]
C0751964
History of drug or alcohol abuse within 2 years of inclusion to the study
Description

Substance abuse disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
Relapse or corticosteroid treatment within 30 days before screening (week -4)
Description

MS relapse; corticosteroid treatment

Data type

boolean

Alias
UMLS CUI [1]
C0856120
UMLS CUI [2]
C0149783
Interferon-beta, glatiramer acetate, teriflunomide, dimethyl fumarate or fingolimod therapy had to have been stopped 3 or more months before enrolment
Description

Therapy Interferon-beta glatiramer acetate teriflunomide dimethyl fumarate fingolimod

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0015980
UMLS CUI [1,3]
C0289884
UMLS CUI [1,4]
C1718383
UMLS CUI [1,5]
C0058218
UMLS CUI [1,6]
C1699926
lmmunosuppressive medication such as azathioprine or methotrexate, Ciclosporin, cyclophosphamide, mycophenolate mofetil, mitoxantrone or cladribine at any time
Description

Therapeutic immunosuppression azathioprine methotrexate

Data type

boolean

Alias
UMLS CUI [1,1]
C0021079
UMLS CUI [1,2]
C0004482
UMLS CUI [1,3]
C0025677
Any previous therapy with alemtuzumab, ocrelizumab, ofatumumab, rituximab, belimumab, natalizumab, total body irradiation, or bone marrow transplantation
Description

Therapy alemtuzumab; body irradiation; bone marrow transplantation

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0383429
UMLS CUI [2]
C0043162
UMLS CUI [3]
C0005961
Any investigational drug or placebo within 12 weeks prior to enrolment OR > 5 half-lives prior to screening (week -4), whichever is longer
Description

investigational drug; placebo

Data type

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0032042
Women that are pregnant or currently breast feeding
Description

Pregnancy; lactating

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
Concurrent participation in other clinical trials
Description

Study subject participation status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
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)
Description

comorbidity malignancy

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0006826
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
Description

contraindication MRI

Data type

boolean

Alias
UMLS CUI [1,1]
C0522473
UMLS CUI [1,2]
C0024485
Hypersensitivity to contrast agent (Gadolinium, resp. Gadopentetat-Dimeglumin)
Description

Hypersensitivity contrast agent

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0009924
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
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
White blood count (WBC) < 3000 mm^3 at screening (week -4)
Description

White blood count

Data type

boolean

Alias
UMLS CUI [1]
C0023508
Lymphocytes < 800 mm^3 at screening (week -4)
Description

Lymphocytes

Data type

boolean

Alias
UMLS CUI [1]
C0200635
Known renal insufficiency stage lll or higher (eGFR <= 59ml/min/1.73m^2; according to the Kidney Disease Outcomes Quality Initiative (KDOQl))
Description

renal insufficiency stage

Data type

boolean

Alias
UMLS CUI [1]
C1565489
Patients with known hypersensitivity to study medication
Description

hypersensitivity study medication

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0304229
Patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other non-steroidal anti-inflammatory drugs (NSAlDs)
Description

hypersensitivity NSAlDs

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0003211
Patients with a history of peptic ulcer disease and/or gastrointestinal bleeding
Description

peptic ulcer disease; gastrointestinal bleeding

Data type

boolean

Alias
UMLS CUI [1]
C0030920
UMLS CUI [2]
C0017181
Chronic or acute renal, hepatic or metabolic disorder
Description

Renal disorder; Hepatic disorder; metabolic disorder

Data type

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0025517
Patients with a history of my myocardial infarction, ischemic stroke or known heart failure
Description

myocardial infarction; ischemic stroke; heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0948008
UMLS CUI [3]
C0018801
Patients with known thrombophilia or abnormal clinically significant coagulation parameter at screening (week -4)
Description

thrombophilia; Blood Coagulation Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0398623
UMLS CUI [2]
C0005779
STUDIENEINSCHLUSS
Description

STUDIENEINSCHLUSS

Alias
UMLS CUI-1
C1512693
Wurde der Patient nach eingehender Prtifung aller Einschluss- und Ausschlusskriterien in die Studie eingeschlossen?
Description

inclusion; exclusion criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0680251
Datum des Einschlusses des Patienten in die Studie
Description

date inclusion

Data type

boolean

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1512693
Alle Visitendaten wurden korrekt und vollstandig in den CRF eingetragen. Alle relevanten Abweichungen wurden dokumentiert.
Description

documentation complete

Data type

boolean

Alias
UMLS CUI [1,1]
C0920316
UMLS CUI [1,2]
C0205197
Datum
Description

date

Data type

date

Alias
UMLS CUI [1]
C0011008
Unterschrift Prtüfarzt
Description

Investigator Signature

Data type

text

Alias
UMLS CUI [1]
C2346576
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Similar models

Screening Visite/ Run-In- Phase (Visite 1/ Woche -4)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Verwaltungsdokumentation
C1320722 (UMLS CUI-1)
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])
Item Group
Demographische Daten
C0011298 (UMLS CUI-1)
Age
Item
Alter
integer
C0001779 (UMLS CUI [1])
Item
Geschlecht
integer
C0079399 (UMLS CUI [1])
Gender
Code List
Geschlecht
CL Item
männlich (1)
CL Item
weiblich (2)
Height
Item
Größe
float
C0005890 (UMLS CUI [1])
Weight
Item
Gewicht
float
C0005910 (UMLS CUI [1])
Item
Ethnische Zugehörigkeit
text
C0015031 (UMLS CUI [1])
Ethnicity
Code List
Ethnische Zugehörigkeit
CL Item
kaukasisch (kaukasisch)
CL Item
afrikanisch (afrikanisch)
CL Item
afro-amerikanisch (afro-amerikanisch)
CL Item
asiatisch (asiatisch)
CL Item
andere (andere)
Item Group
Gebärfähigkeit
C3831118 (UMLS CUI-1)
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)
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])
Item Group
Krankengeschichte und Begleiterkrankungen
C0009488 (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])
medical history; Comorbidity
Item
Begleiterkrankungen und sonstige Krankengeschichte (inkl. Operationen)
text
C0262926 (UMLS CUI [1])
C0009488 (UMLS CUI [2])
Concomitant medication
Item
Begleitmedikation
text
C2347852 (UMLS CUI [1])
Item Group
Körperliche Untersuchung
C0031809 (UMLS CUI-1)
Item
Allgemeiner Zustand
text
C1142435 (UMLS CUI [1])
General physical condition
Code List
Allgemeiner Zustand
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])
Item
Haut
text
C1123023 (UMLS CUI [1])
General physical condition
Code List
Haut
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])
Item
Augen
text
C0015392 (UMLS CUI [1])
General physical condition
Code List
Augen
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])
Item
Ohren
text
C0013443 (UMLS CUI [1])
General physical condition
Code List
Ohren
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])
Item
Nase
text
C0028429 (UMLS CUI [1])
General physical condition
Code List
Nase
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])
Item
Hals
text
C0031354 (UMLS CUI [1])
General physical condition
Code List
Hals
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])
Item
Herz/ Lunge
text
C0018787 (UMLS CUI [1])
C0024109 (UMLS CUI [2])
General physical condition
Code List
Herz/ Lunge
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])
Item
Abdomen
text
C0000726 (UMLS CUI [1])
General physical condition
Code List
Abdomen
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])
Item
Lymphknoten
text
C0024204 (UMLS CUI [1])
General physical condition
Code List
Lymphknoten
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])
Item
Extremitäten
text
C0278454 (UMLS CUI [1])
General physical condition
Code List
Extremitäten
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])
Item Group
Urinanalyse
C0042014 (UMLS CUI-1)
Urine pH
Item
pH
text
C0042044 (UMLS CUI [1])
Item
Leukozyten
text
C0023516 (UMLS CUI [1])
Leukocytes
Code List
Leukozyten
CL Item
negativ (negativ)
CL Item
positiv (positiv)
Item
Bewertung
text
C1516048 (UMLS CUI [1])
assessment
Code List
Bewertung
CL Item
abnormal, nicht klinisch signifikant (abnormal, nicht klinisch signifikant)
CL Item
abnormal, klinisch signifikant (abnormal, klinisch signifikant)
Item
Nitrit
text
C0580333 (UMLS CUI [1])
Leukocytes
Code List
Nitrit
CL Item
negativ (negativ)
CL Item
positiv (positiv)
Item
Bewertung
text
C1516048 (UMLS CUI [1])
assessment
Code List
Bewertung
CL Item
abnormal, nicht klinisch signifikant (abnormal, nicht klinisch signifikant)
CL Item
abnormal, klinisch signifikant (abnormal, klinisch signifikant)
Item
Proteine
text
C0262923 (UMLS CUI [1])
Leukocytes
Code List
Proteine
CL Item
negativ (negativ)
CL Item
positiv (positiv)
Item
Bewertung
text
C1516048 (UMLS CUI [1])
assessment
Code List
Bewertung
CL Item
abnormal, nicht klinisch signifikant (abnormal, nicht klinisch signifikant)
CL Item
abnormal, klinisch signifikant (abnormal, klinisch signifikant)
Item
Glukose
text
C0004076 (UMLS CUI [1])
Leukocytes
Code List
Glukose
CL Item
negativ (negativ)
CL Item
positiv (positiv)
Item
Bewertung
text
C1516048 (UMLS CUI [1])
assessment
Code List
Bewertung
CL Item
abnormal, nicht klinisch signifikant (abnormal, nicht klinisch signifikant)
CL Item
abnormal, klinisch signifikant (abnormal, klinisch signifikant)
Item
Ketone
text
C0555179 (UMLS CUI [1])
Leukocytes
Code List
Ketone
CL Item
negativ (negativ)
CL Item
positiv (positiv)
Item
Bewertung
text
C1516048 (UMLS CUI [1])
assessment
Code List
Bewertung
CL Item
abnormal, nicht klinisch signifikant (abnormal, nicht klinisch signifikant)
CL Item
abnormal, klinisch signifikant (abnormal, klinisch signifikant)
Item
Urobilinogen
text
C0042052 (UMLS CUI [1])
Leukocytes
Code List
Urobilinogen
CL Item
negativ (negativ)
CL Item
positiv (positiv)
Item
Bewertung
text
C1516048 (UMLS CUI [1])
assessment
Code List
Bewertung
CL Item
abnormal, nicht klinisch signifikant (abnormal, nicht klinisch signifikant)
CL Item
abnormal, klinisch signifikant (abnormal, klinisch signifikant)
Item
Bilirubin
text
C0042040 (UMLS CUI [1])
Leukocytes
Code List
Bilirubin
CL Item
negativ (negativ)
CL Item
positiv (positiv)
Item
Bewertung
text
C1516048 (UMLS CUI [1])
assessment
Code List
Bewertung
CL Item
abnormal, nicht klinisch signifikant (abnormal, nicht klinisch signifikant)
CL Item
abnormal, klinisch signifikant (abnormal, klinisch signifikant)
Item
Erythrozyten
text
C2188659 (UMLS CUI [1])
Leukocytes
Code List
Erythrozyten
CL Item
negativ (negativ)
CL Item
positiv (positiv)
Item
Bewertung
text
C1516048 (UMLS CUI [1])
assessment
Code List
Bewertung
CL Item
abnormal, nicht klinisch signifikant (abnormal, nicht klinisch signifikant)
CL Item
abnormal, klinisch signifikant (abnormal, klinisch signifikant)
Item
Ergebnis Schwangerschaftstest im Urin
text
C0430056 (UMLS CUI [1])
Urine pregnancy test
Code List
Ergebnis Schwangerschaftstest im Urin
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])
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])
Item Group
Blutprobe zum Versand an Zentrallabor Frankfurt
C0005834 (UMLS CUI-1)
Date blood sampling
Item
Datum der Blutentnahme
date
C1264639 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Time blood sampling
Item
Uhrzeit der Blutentnahme
time
C0040223 (UMLS CUI [1,1])
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])
Cerebellum; Cerebellar Ataxia
Item
2. Kleinhirn (z.B. Atexie, Tremor) Grad
integer
C0007765 (UMLS CUI [1])
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])
Sensory; Hypesthesia
Item
4. Sensorium (z.B. Verminderung des Berührungssinns) Grad
integer
C0445254 (UMLS CUI [1])
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])
visual acuity; Scotoma
Item
6. Sehfunktionen (z.B. eingeschränktes Gesichtsfeld- Skotom) Grad
integer
C0042812 (UMLS CUI [1])
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])
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])
Item Group
Einschlusskriterien
C1512693 (UMLS CUI-1)
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])
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])
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])
Item Group
Auschlusskriterien
C0680251 (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])
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])
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])
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])
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])
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])
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])
Pregnancy; lactating
Item
Women that are pregnant or currently breast feeding
boolean
C0032961 (UMLS CUI [1,1])
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])
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])
Hypersensitivity contrast agent
Item
Hypersensitivity to contrast agent (Gadolinium, resp. Gadopentetat-Dimeglumin)
boolean
C0020517 (UMLS CUI [1,1])
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])
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])
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])
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])
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])
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])
Item Group
STUDIENEINSCHLUSS
C1512693 (UMLS CUI-1)
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])
date inclusion
Item
Datum des Einschlusses des Patienten in die Studie
boolean
C0011008 (UMLS CUI [1,1])
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])
date
Item
Datum
date
C0011008 (UMLS CUI [1])
Investigator Signature
Item
Unterschrift Prtüfarzt
text
C2346576 (UMLS CUI [1])
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