ID

28143

Beschreibung

Double blind, randomised, prospective placebo controlled parallel group phase III study to investigate the effect of EGCG supplementation on disease progression of patients with Multiple System Atrophy (MSA) NCT02008721 Short title: Progression Rate of MSA under EGCG Supplementation as anti-Aggregation-Approach Study Code: PROMESA EudraCT-Number: 2012-000928-18 NCT02008721 Sponsor: Klinikum Großhadern Medical Center University of Munich,Represented by the Medical Director Prof. Dr. med. Burkhard Göke, Marchioninistraße 15 D-81377 Munich Principal Investigator: Prof. Dr. med. Günter Höglinger Department of Neurology, Klinikum rechts der Isar Technische Universität München Ismaninger Str. 22 D-81675 Munich; Contact: Yvonne Rödenbeck Trial Monitoring: Münchner Studienzentrum Klinikum rechts der Isar ,Technische Universität München, Ismaninger Str.22 D-81675 Munich Trial Monitoring: Prof. Dr. rer. nat. Ulrich Masnmann, Institute for Medical Informatics, Biometry and Epidemiology (IBE), Marchioninistraße 15 D-81377 Munich Trial Office: Deutsches Zentrum für Neurodegenerative Erkrankungen e.V., Max-Lebsche Platz 30, D-81377 Munich Source: Priv.-Doz. Dr. med. Johannes Levin Neurologische Klinik Ludwig-Maximilians-Universität München

Stichworte

Versionen (1)
  1. 21.12.17 21.12.17 -
Rechteinhaber

Priv.-Doz. Dr. med. Johannes Levin

Hochgeladen am

21. Dezember 2017

DOI

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Lizenz

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PROMESA NCT02008721

Englisch

12 Week control visit (V4)

1 Formulare  
Date of Visit
Beschreibung

Date of Visit

Alias
UMLS CUI-1
C2097637
Date of visit
Beschreibung

Date of visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Recent Medical history
Beschreibung

Recent Medical history

Alias
UMLS CUI-1
C0262926
Changes in relevant medical history since last visit
Beschreibung

relevant medical history

Datentyp

integer

Alias
UMLS CUI [1]
C0262926
Are there any adverse events since last visit?
Beschreibung

If yes, please fill in AE FORM.

Datentyp

boolean

Alias
UMLS CUI [1]
C0877248
Changes in MSA History since last visit (V3)
Beschreibung

Changes in MSA History since last visit (V3)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0393571
UMLS CUI [1,2]
C1457887
Syncope
Beschreibung

MSA syncope

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0393571
UMLS CUI [1,2]
C0039070
Orthostatic hypotension
Beschreibung

MSA Orthostatic hypotension

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0393571
UMLS CUI [1,2]
C0020651
Urinary Incontinence
Beschreibung

MSA Urinary Incontinence

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0393571
UMLS CUI [1,2]
C0042024
Erectile Dysfuntion
Beschreibung

MSA Erectile Dysfuntion

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0393571
UMLS CUI [1,2]
C2733447
Other (please specify)
Beschreibung

MSA Other autonomic symptoms

Datentyp

text

Alias
UMLS CUI [1,1]
C0393571
UMLS CUI [1,2]
C2674101
UMLS CUI [1,3]
C1521902
Bradykinesia
Beschreibung

MSA Bradykinesia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2733447
UMLS CUI [1,2]
C3176307
Rigidity
Beschreibung

MSA Rigidity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2733447
UMLS CUI [1,2]
C0858572
Tremor
Beschreibung

MSA Tremor

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2733447
UMLS CUI [1,2]
C0040822
Resting tremor
Beschreibung

Only answer, if answer to previous question was 'yes'.

Datentyp

boolean

Alias
UMLS CUI [1]
C0234379
Postural tremor
Beschreibung

Only answer, if answer to previous question was 'yes'.

Datentyp

boolean

Alias
UMLS CUI [1]
C0234378
other (please specify)
Beschreibung

MSA Other parkinsonism symptoms

Datentyp

text

Alias
UMLS CUI [1,1]
C2733447
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C1521902
Gait ataxia
Beschreibung

MSA Gait ataxia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2732311
UMLS CUI [1,2]
C0751837
Limb ataxia
Beschreibung

MSA limb ataxia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2732311
UMLS CUI [1,2]
C4015302
Other (please specify)
Beschreibung

MSA Other cerebellar symptoms

Datentyp

text

Alias
UMLS CUI [1,1]
C2732311
UMLS CUI [1,2]
C0037088
UMLS CUI [1,3]
C1521902
Current frequency of falls
Beschreibung

since last visit

Datentyp

integer

Alias
UMLS CUI [1]
C1285588
Concomitant medication
Beschreibung

Concomitant medication

Alias
UMLS CUI-1
C2347852
Does the patient take any concomitant medication?
Beschreibung

If Yes, please fill in Concomitant Medication Record.

Datentyp

boolean

Alias
UMLS CUI [1]
C2347852
Has the patient a stable regimen for drugs acting against Parkinsonism.
Beschreibung

Parkinson drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0003405
Has the patient a stable regimen for drugs acting against autonomic dysfunction.
Beschreibung

pharmaceutical preparation autonomic dysfunction

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C3277919
Has the patient a stable regimen for antidepressant and antidementive drugs.
Beschreibung

antidepressant and antidementive drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0003289
UMLS CUI [1,3]
C0497327
Vital signs
Beschreibung

Vital signs

Alias
UMLS CUI-1
C0031809
Systolic Blood Pressure
Beschreibung

Systolic Blood Pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic blood pressure
Beschreibung

Diastolic blood pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Beschreibung

Heart rate

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Temperature
Beschreibung

Body Temperature

Datentyp

integer

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Physical examination
Beschreibung

Physical examination

Alias
UMLS CUI-1
C0031809
General physical examination
Beschreibung

General physical examination

Datentyp

integer

Alias
UMLS CUI [1]
C0031809
Physical examination
Beschreibung

Physical examination

Alias
UMLS CUI-1
C0031809
Code
Beschreibung

pHysical examination code

Datentyp

integer

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0805701
Finding
Beschreibung

physical examination finding

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0243095
Neurological examination
Beschreibung

Neurological examination

Alias
UMLS CUI-1
C0027853
Cranial nerves
Beschreibung

Neurologic examination cranial nerves

Datentyp

integer

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C0558819
If abnormal, specify
Beschreibung

cranial nerves examination specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C0558819
UMLS CUI [1,3]
C1521902
Motor function
Beschreibung

Neurologic examination Motor function

Datentyp

integer

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C0234130
If abnormal, specify
Beschreibung

Motor function specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C0234130
UMLS CUI [1,3]
C1521902
Reflexes
Beschreibung

Neurologic examination Reflexes

Datentyp

integer

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C0436145
If abnormal, specify
Beschreibung

Reflexes specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C0436145
UMLS CUI [1,3]
C1521902
Coordination
Beschreibung

Neurologic examination coordination

Datentyp

integer

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C0242414
If abnormal, specify
Beschreibung

Coordination specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C0242414
UMLS CUI [1,3]
C1521902
Sensation
Beschreibung

Neurologic examination sensation

Datentyp

integer

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C0036658
If abnormal, specify
Beschreibung

Sensation specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C0036658
UMLS CUI [1,3]
C1521902
Laboratory test
Beschreibung

Laboratory test

Alias
UMLS CUI-1
C0022885
Date
Beschreibung

d laboratory! Please fill in the raised values and assess whether they´re normal or not. If abnormal, evaluate if it is clinically significant or not. If the value is abnormal and clinically significant, please document as concomitant disease under medical history.

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0022885
Laboratory test performed?
Beschreibung

laboratory procedures

Datentyp

text

Alias
UMLS CUI [1]
C0022885
Laboratory test
Beschreibung

Laboratory test

Alias
UMLS CUI-1
C0022885
Type of laboratory procedure
Beschreibung

Type of laboratory procedure

Datentyp

integer

Alias
UMLS CUI [1]
C0022885
Value
Beschreibung

Laboratory procedure value

Datentyp

float

Alias
UMLS CUI [1,1]
C0587081
UMLS CUI [1,2]
C0587081
Normal
Beschreibung

Laboratory result normal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0587081
UMLS CUI [1,2]
C0459422
Clinical significant
Beschreibung

Laboratory finding significant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C0750502
Clinically not significant
Beschreibung

Laboratory finding not significant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0587081
UMLS CUI [1,2]
C2985739
Not done
Beschreibung

Laboratory test not done

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0445106
Study medication
Beschreibung

Study medication

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0304229
Did any study-drug side effects occur?
Beschreibung

If yes, please fill out AE form!

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0041755
Did the patient regularly take the study-drug?
Beschreibung

regular intake of study medication

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0205272
If no, please explain:
Beschreibung

Study medication intake

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0205272
Number of capsules returned
Beschreibung

Number of capsules returned

Datentyp

integer

Alias
UMLS CUI [1,1]
C2699071
UMLS CUI [1,2]
C0039225
Comment (in case of missing capsules)
Beschreibung

Missing capsules

Datentyp

text

Alias
UMLS CUI [1,1]
C1705492
UMLS CUI [1,2]
C0178602
Trial medication exchange
Beschreibung

Trial medication exchange

Datentyp

integer

Alias
UMLS CUI [1,1]
C3854006
UMLS CUI [1,2]
C3469597
Date
Beschreibung

Date of study drug exchange

Datentyp

date

Alias
UMLS CUI [1,1]
C3854006
UMLS CUI [1,2]
C3469597
UMLS CUI [1,3]
C0011008
Regimen
Beschreibung

e.g. 1-0-1

Datentyp

text

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0035258
UMLS CUI [1,3]
C0237125
Total dose (mg/d)
Beschreibung

Total dose study medication

Datentyp

integer

Alias
UMLS CUI [1]
C3174092
Number of Capsules dispensed
Beschreibung

Capsules (EGCG 400mg or Placebo) Regimen 1-1-1 Total dose 1200mg/d

Datentyp

integer

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0805077
Planned new dosis start
Beschreibung

Planned medication start

Datentyp

date

Alias
UMLS CUI [1,1]
C1521826
UMLS CUI [1,2]
C0808070
Total dose according to protocol (1200 mg/d)?
Beschreibung

Total dose

Datentyp

boolean

Alias
UMLS CUI [1]
C3174092
If no, please explain
Beschreibung

Dosage different than according to protocol

Datentyp

text

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C2348563
Signature of investigator
Beschreibung

Signature of investigator

Alias
UMLS CUI-1
C2346576
Date of Investigator Signature
Beschreibung

Investigator Signature Date

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Name of investigator
Beschreibung

Investigator name

Datentyp

text

Alias
UMLS CUI [1]
C2826892
Investigator signature
Beschreibung

I confirm the correctness of the data documented above.

Datentyp

text

Alias
UMLS CUI [1]
C2346576
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Ähnliche Modelle

12 Week control visit (V4)

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Date of Visit
C2097637 (UMLS CUI-1)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item Group
Recent Medical history
C0262926 (UMLS CUI-1)
Item
Changes in relevant medical history since last visit
integer
C0262926 (UMLS CUI [1])
relevant medical history
Code List
Changes in relevant medical history since last visit
CL Item
Yes (please specify below) (1)
CL Item
No (2)
adverse event
Item
Are there any adverse events since last visit?
boolean
C0877248 (UMLS CUI [1])
Changes in MSA History since last visit (V3)
Item
Changes in MSA History since last visit (V3)
boolean
C0393571 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
MSA syncope
Item
Syncope
boolean
C0393571 (UMLS CUI [1,1])
C0039070 (UMLS CUI [1,2])
MSA Orthostatic hypotension
Item
Orthostatic hypotension
boolean
C0393571 (UMLS CUI [1,1])
C0020651 (UMLS CUI [1,2])
MSA Urinary Incontinence
Item
Urinary Incontinence
boolean
C0393571 (UMLS CUI [1,1])
C0042024 (UMLS CUI [1,2])
MSA Erectile Dysfuntion
Item
Erectile Dysfuntion
boolean
C0393571 (UMLS CUI [1,1])
C2733447 (UMLS CUI [1,2])
MSA Other autonomic symptoms
Item
Other (please specify)
text
C0393571 (UMLS CUI [1,1])
C2674101 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
MSA Bradykinesia
Item
Bradykinesia
boolean
C2733447 (UMLS CUI [1,1])
C3176307 (UMLS CUI [1,2])
MSA Rigidity
Item
Rigidity
boolean
C2733447 (UMLS CUI [1,1])
C0858572 (UMLS CUI [1,2])
MSA Tremor
Item
Tremor
boolean
C2733447 (UMLS CUI [1,1])
C0040822 (UMLS CUI [1,2])
Resting tremor
Item
Resting tremor
boolean
C0234379 (UMLS CUI [1])
Postural tremor
Item
Postural tremor
boolean
C0234378 (UMLS CUI [1])
MSA Other parkinsonism symptoms
Item
other (please specify)
text
C2733447 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
MSA Gait ataxia
Item
Gait ataxia
boolean
C2732311 (UMLS CUI [1,1])
C0751837 (UMLS CUI [1,2])
MSA limb ataxia
Item
Limb ataxia
boolean
C2732311 (UMLS CUI [1,1])
C4015302 (UMLS CUI [1,2])
MSA Other cerebellar symptoms
Item
Other (please specify)
text
C2732311 (UMLS CUI [1,1])
C0037088 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item
Current frequency of falls
integer
C1285588 (UMLS CUI [1])
frequency of falls
Code List
Current frequency of falls
CL Item
several times per day (1)
CL Item
several times per week (2)
CL Item
several times per month (3)
CL Item
several times per year (4)
Item Group
Concomitant medication
C2347852 (UMLS CUI-1)
Concomitant Medication
Item
Does the patient take any concomitant medication?
boolean
C2347852 (UMLS CUI [1])
Parkinson drugs
Item
Has the patient a stable regimen for drugs acting against Parkinsonism.
boolean
C0003405 (UMLS CUI [1])
pharmaceutical preparation autonomic dysfunction
Item
Has the patient a stable regimen for drugs acting against autonomic dysfunction.
boolean
C0013227 (UMLS CUI [1,1])
C3277919 (UMLS CUI [1,2])
antidepressant and antidementive drugs
Item
Has the patient a stable regimen for antidepressant and antidementive drugs.
boolean
C0013227 (UMLS CUI [1,1])
C0003289 (UMLS CUI [1,2])
C0497327 (UMLS CUI [1,3])
Item Group
Vital signs
C0031809 (UMLS CUI-1)
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Body Temperature
Item
Temperature
integer
C0005903 (UMLS CUI [1])
Item Group
Physical examination
C0031809 (UMLS CUI-1)
Item
integer
C0031809 (UMLS CUI [1])
General physical examination
Code List
General physical examination
CL Item
normal (1)
CL Item
abnormal (please specify below) (2)
Item Group
Physical examination
C0031809 (UMLS CUI-1)
Item
Code
integer
C0031809 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
pHysical examination code
Code List
Code
CL Item
Cardiovascular (01)
CL Item
Pulmonary (02)
CL Item
Abdominal (03)
CL Item
Genitourinary (04)
CL Item
Skeletal/Muscular (05)
CL Item
Psychiatric (06)
CL Item
other (07)
physical examination finding
Item
Finding
text
C0031809 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
Item Group
Neurological examination
C0027853 (UMLS CUI-1)
Item
Cranial nerves
integer
C0027853 (UMLS CUI [1,1])
C0558819 (UMLS CUI [1,2])
Neurologic examination cranial nerves
Code List
Cranial nerves
CL Item
normal (1)
CL Item
abnormal (2)
cranial nerves examination specify
Item
If abnormal, specify
text
C0027853 (UMLS CUI [1,1])
C0558819 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item
Motor function
integer
C0027853 (UMLS CUI [1,1])
C0234130 (UMLS CUI [1,2])
Neurologic examination Motor function
Code List
Motor function
CL Item
normal (1)
CL Item
abnormal (2)
Motor function specify
Item
If abnormal, specify
text
C0027853 (UMLS CUI [1,1])
C0234130 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item
Reflexes
integer
C0027853 (UMLS CUI [1,1])
C0436145 (UMLS CUI [1,2])
Neurologic examination Reflexes
Code List
Reflexes
CL Item
normal (1)
CL Item
abnormal (2)
Reflexes specify
Item
If abnormal, specify
text
C0027853 (UMLS CUI [1,1])
C0436145 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item
Coordination
integer
C0027853 (UMLS CUI [1,1])
C0242414 (UMLS CUI [1,2])
Neurologic examination coordination
Code List
Coordination
CL Item
normal (1)
CL Item
abnormal (2)
Coordination specify
Item
If abnormal, specify
text
C0027853 (UMLS CUI [1,1])
C0242414 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item
Sensation
integer
C0027853 (UMLS CUI [1,1])
C0036658 (UMLS CUI [1,2])
Neurologic examination sensation
Code List
Sensation
CL Item
normal (1)
CL Item
abnormal (2)
Sensation specify
Item
If abnormal, specify
text
C0027853 (UMLS CUI [1,1])
C0036658 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item Group
Laboratory test
C0022885 (UMLS CUI-1)
Date laboratory
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Item
Laboratory test performed?
text
C0022885 (UMLS CUI [1])
laboratory procedures
Code List
Laboratory test performed?
CL Item
done (1)
CL Item
not done (2)
Item Group
Laboratory test
C0022885 (UMLS CUI-1)
Item
Type of laboratory procedure
integer
C0022885 (UMLS CUI [1])
Type of laboratory procedure
Code List
Type of laboratory procedure
CL Item
Erythrocytes T/L (1)
CL Item
Leukocytes G/L (2)
CL Item
Thrombocytes G/L (3)
CL Item
Hemoglobin g/dL (4)
CL Item
PTT sec (5)
CL Item
PchE kU/L (6)
CL Item
GOT (AST) U/L (7)
CL Item
GPT (ALT) U/L (8)
CL Item
Bilirubin mg/dL (9)
CL Item
Creatinine mg/dL (10)
CL Item
Creatine Kinase U/L (11)
CL Item
Potassium mmol/L (12)
CL Item
Sodium mmol/L (13)
CL Item
GFR mL/min (14)
Laboratory procedure value
Item
Value
float
C0587081 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Laboratory result normal
Item
Normal
boolean
C0587081 (UMLS CUI [1,1])
C0459422 (UMLS CUI [1,2])
Laboratory finding significant
Item
Clinical significant
boolean
C0456984 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
Laboratory finding not significant
Item
Clinically not significant
boolean
C0587081 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Laboratory test not done
Item
Not done
boolean
C0022885 (UMLS CUI [1,1])
C0445106 (UMLS CUI [1,2])
Item Group
Study medication
C0013227 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
side effects study drug
Item
Did any study-drug side effects occur?
boolean
C0304229 (UMLS CUI [1,1])
C0041755 (UMLS CUI [1,2])
regular intake of study medication
Item
Did the patient regularly take the study-drug?
boolean
C0013227 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0205272 (UMLS CUI [1,3])
Study medication intake
Item
If no, please explain:
text
C0013227 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0205272 (UMLS CUI [1,3])
Number of capsules returned
Item
Number of capsules returned
integer
C2699071 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
Missing capsules
Item
Comment (in case of missing capsules)
text
C1705492 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Item
Trial medication exchange
integer
C3854006 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
Trial medication distribution
Code List
Trial medication exchange
CL Item
done  (1)
CL Item
not done (2)
Date of study drug exchange
Item
Date
date
C3854006 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Study medication regimen
Item
Regimen
text
C0008976 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
C0237125 (UMLS CUI [1,3])
Total dose study medication
Item
Total dose (mg/d)
integer
C3174092 (UMLS CUI [1])
Number of Capsules dispensed
Item
Number of Capsules dispensed
integer
C0013227 (UMLS CUI [1,1])
C0805077 (UMLS CUI [1,2])
Planned medication start
Item
Planned new dosis start
date
C1521826 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Total dose
Item
Total dose according to protocol (1200 mg/d)?
boolean
C3174092 (UMLS CUI [1])
Dosage different than according to protocol
Item
If no, please explain
text
C3174092 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Item Group
Signature of investigator
C2346576 (UMLS CUI-1)
Investigator Signature Date
Item
Date of Investigator Signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator name
Item
Name of investigator
text
C2826892 (UMLS CUI [1])
Investigator signature
Item
Investigator signature
text
C2346576 (UMLS CUI [1])
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