ID

30518

Description

MIPSO Vergleichende Untersuchung der bakteriellen Mikrobiota in der Haut sowie dem Darm von Psoriasis-Patienten vor und nach systemischer Behandlung mit Adalimumab bzw. Ustekinumab oder Ciclosporin (EudraCT 2014-003022-40) Principal Investigator: Prof. Dr. Dr. h.c. Thomas A. Luger PASI: Fredriksson T, Pettersson U: Severe psoria - sis – Oral therapy with a new retinoid. Dermatologica 178; 157: 238–244.

Keywords

Versions (4)
  1. 9/27/17 9/27/17 -
  2. 9/27/17 9/27/17 -
  3. 9/27/17 9/27/17 -
  4. 6/11/18 6/11/18 - Sarah Riepenhausen
Copyright Holder

University Hospital Münster; Fredriksson T, Pettersson U: Severe psoria - sis – Oral therapy with a new retinoid. Dermatologica 178; 157: 238–244.

Uploaded on

June 11, 2018

DOI

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License

Creative Commons BY-NC 3.0
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PASI Psoriasis MIPSO EudraCT 2014-003022-40

English

PASI Psoriasis MIPSO EudraCT 2014-003022-40

1 forms  
Use of the form
Description

Use of the form

Alias
UMLS CUI-1
C0457083
UMLS CUI-2
C1516308
Form has to be used several times. Please mark the time of use.
Description

Form has to be used several times. Please mark the time of use.

Data type

integer

Alias
UMLS CUI [1,1]
C1516308
UMLS CUI [1,2]
C1265611
Psoriasis Area and Severity Index
Description

Psoriasis Area and Severity Index

Alias
UMLS CUI-1
C4528685
Erythema Head / Neck
Description

CDISC Definition: Psoriasis Area and Severity Index - Head (H): Erythema (E).

Data type

integer

Alias
UMLS CUI [1]
C4526023
Erythema Arms
Description

CDISC Defnition: Psoriasis Area and Severity Index - Upper Extremities (U): Erythema (E).

Data type

integer

Alias
UMLS CUI [1]
C4526037
Erythema Trunk (incl. axillae + groins)
Description

CDISC Definition: Psoriasis Area and Severity Index - Trunk (T): Erythema (E).

Data type

integer

Alias
UMLS CUI [1]
C4526030
Erythema Legs (incl. gluteal)
Description

CDISC Definition: Psoriasis Area and Severity Index - Lower Extremities (L): Erythema (E).

Data type

integer

Alias
UMLS CUI [1]
C4526044
Induration Head / Neck
Description

CDISC Definition: Psoriasis Area and Severity Index - Head (H): Infiltration (I).

Data type

integer

Alias
UMLS CUI [1]
C4526024
Induration Arms
Description

CDISC Definition: Psoriasis Area and Severity Index - Upper Extremities (U): Infiltration (I).

Data type

integer

Alias
UMLS CUI [1]
C4526038
Induration Trunk (incl. axillae + groins)
Description

CDISC Definition: Psoriasis Area and Severity Index - Trunk (T): Infiltration (I).

Data type

integer

Alias
UMLS CUI [1]
C4526031
Induration Legs (incl. gluteal)
Description

CDISC Definition: Psoriasis Area and Severity Index - Lower Extremities (L): Infiltration (I).

Data type

integer

Alias
UMLS CUI [1]
C4526045
Desquamation Head / Neck
Description

CDISC Definition: Psoriasis Area and Severity Index - Head (H): Desquamation (D).

Data type

integer

Alias
UMLS CUI [1]
C4526025
Desquamation Arms
Description

CDISC Definition: Psoriasis Area and Severity Index - Upper Extremities (U): Desquamation (D).

Data type

integer

Alias
UMLS CUI [1]
C4526039
Desquamation Trunk (incl. axillae + groins)
Description

CDISC Definition: Psoriasis Area and Severity Index - Trunk (T): Desquamation (D).

Data type

integer

Alias
UMLS CUI [1]
C4526032
Desquamation Legs (incl. gluteal)
Description

CDISC Definition: Psoriasis Area and Severity Index - Lower Extremities (L): Desquamation (D).

Data type

integer

Alias
UMLS CUI [1]
C4526046
Subtotal A1: Head/Neck
Description

Subtotal A1: Erythema + Induration + Dequamation CDISC Definition: Psoriasis Area and Severity Index - Head (H): Sum = E + I + D.

Data type

integer

Alias
UMLS CUI [1]
C4526026
Subtotal A2: Arms
Description

Subtotal A2: Erythema + Induration + Dequamation CDISC Definition: Psoriasis Area and Severity Index - Upper Extremities (U): Sum = E + I + D.

Data type

integer

Alias
UMLS CUI [1]
C4526040
Subtotal A3: Trunk
Description

Subtotal A3: Erythema + Induration + Dequamation CDISC Definition: Psoriasis Area and Severity Index - Trunk (T): Sum = E + I + D.

Data type

integer

Alias
UMLS CUI [1]
C4526033
Subtotal A4: Legs
Description

Subtotal A4: Erythema + Induration + Dequamation CDISC Definition: Psoriasis Area and Severity Index - Lower Extremities (L): Sum = E + I + D.

Data type

integer

Alias
UMLS CUI [1]
C4526047
Affected Area Head / Neck
Description

CDISC Definition: Psoriasis Area and Severity Index - Head (H): Area score.

Data type

integer

Alias
UMLS CUI [1]
C4526027
Affected Area Arms
Description

CDISC Definition: Psoriasis Area and Severity Index - Upper Extremities (U): Area score.

Data type

integer

Alias
UMLS CUI [1]
C4526041
Affected Area Trunk (incl. axillae + groins)
Description

CDISC Definition: Psoriasis Area and Severity Index - Trunk (T): Area score.

Data type

integer

Alias
UMLS CUI [1]
C4526034
Affected Area Legs (incl. gluteal)
Description

CDISC Definition: Psoriasis Area and Severity Index - Lower Extremities (L): Area score.

Data type

integer

Alias
UMLS CUI [1]
C4526041
Subtotal B1: Head/Neck
Description

Subtotal B1: A1 * Area CDISC Definition: Psoriasis Area and Severity Index - Head (H): Sum x area.

Data type

integer

Alias
UMLS CUI [1]
C4526028
Subtotal B2: Arms
Description

Subtotal B2: A2 * Area CDISC Definition: Psoriasis Area and Severity Index - Upper Extremities (U): Sum x area.

Data type

integer

Alias
UMLS CUI [1]
C4526042
Subtotal B3: Trunk (incl. axillae + groins)
Description

Subtotal B3: A3 * Area CDISC Definition: Psoriasis Area and Severity Index - Trunk (T): Sum x area.

Data type

integer

Alias
UMLS CUI [1]
C4526035
Subtotal B4: Legs (incl. gluteal)
Description

Subtotal B4: A4 * Area CDISC Definition: Psoriasis Area and Severity Index - Lower Extremities (L): Sum x area.

Data type

integer

Alias
UMLS CUI [1]
C4526049
Subtotal C1: Head/Neck
Description

Subtotal C1: B1 * 0,1 CDISC Definition: Psoriasis Area and Severity Index - Head (H): Sum x area x 0.1.

Data type

float

Alias
UMLS CUI [1]
C4526029
Subtotal C2: Arms
Description

Subtotal C2: B2 * 0,2 CDISC Definition: Psoriasis Area and Severity Index - Upper Extremities (U): Sum x area x 0.2.

Data type

float

Alias
UMLS CUI [1]
C4526043
Subtotal C3: Trunk (incl. axillae + groins)
Description

Subtotal C3: B3 * 0,3 CDISC Definition: Psoriasis Area and Severity Index - Trunk (T): Sum x area x 0.3.

Data type

float

Alias
UMLS CUI [1]
C4526036
Subtotal C4: Legs (incl. gluteal)
Description

Subtotal C4: B4 * 0,4 CDISC Definition: Psoriasis Area and Severity Index - Lower Extremities (L): Sum x area x 0.4.

Data type

float

Alias
UMLS CUI [1]
C4526050
PASI Total Score
Description

PASI Total: C1+C2+C3+C4 CDISC Definition: Psoriasis Area and Severity Index - Total sum.

Data type

float

Alias
UMLS CUI [1]
C4526051
Total Body Surface Area with Psoriasis
Description

Total Body Surface Area with Psoriasis

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1,1]
C0005902
UMLS CUI [1,2]
C0033860
%
Signature date
Description

Signature date

Data type

date

Alias
UMLS CUI [1]
C0807937
PASI Comments
Description

PASI Comments

Data type

text

Alias
UMLS CUI [1,1]
C4528685
UMLS CUI [1,2]
C0947611
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Similar models

PASI Psoriasis MIPSO EudraCT 2014-003022-40

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Use of the form
C0457083 (UMLS CUI-1)
C1516308 (UMLS CUI-2)
Item
Form has to be used several times. Please mark the time of use.
integer
C1516308 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
The time of use
Code List
Form has to be used several times. Please mark the time of use.
CL Item
Screening (1)
CL Item
Visite 1 (Baseline) (2)
CL Item
Visite 2 (Week 4) (3)
CL Item
Visite 3 (Week 8) (4)
CL Item
Visite 4 (Week 12) (5)
CL Item
Visite 5 (Week 16) (6)
CL Item
Visite 6 (Week 20) (7)
CL Item
Visite 7 (Week 24) (8)
CL Item
Termination visite (9)
Item Group
Psoriasis Area and Severity Index
C4528685 (UMLS CUI-1)
Item
Erythema Head / Neck
integer
C4526023 (UMLS CUI [1])
Erythema Head / Neck
Code List
Erythema Head / Neck
CL Item
none (0)
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
CL Item
very severe (4)
Item
Erythema Arms
integer
C4526037 (UMLS CUI [1])
Erythema Head / Neck
Code List
Erythema Arms
CL Item
none (0)
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
CL Item
very severe (4)
Item
Erythema Trunk (incl. axillae + groins)
integer
C4526030 (UMLS CUI [1])
Erythema Head / Neck
Code List
Erythema Trunk (incl. axillae + groins)
CL Item
none (0)
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
CL Item
very severe (4)
Item
Erythema Legs (incl. gluteal)
integer
C4526044 (UMLS CUI [1])
Erythema Head / Neck
Code List
Erythema Legs (incl. gluteal)
CL Item
none (0)
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
CL Item
very severe (4)
Item
Induration Head / Neck
integer
C4526024 (UMLS CUI [1])
Erythema Head / Neck
Code List
Induration Head / Neck
CL Item
none (0)
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
CL Item
very severe (4)
Item
Induration Arms
integer
C4526038 (UMLS CUI [1])
Erythema Head / Neck
Code List
Induration Arms
CL Item
none (0)
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
CL Item
very severe (4)
Item
Induration Trunk (incl. axillae + groins)
integer
C4526031 (UMLS CUI [1])
Erythema Head / Neck
Code List
Induration Trunk (incl. axillae + groins)
CL Item
none (0)
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
CL Item
very severe (4)
Item
Induration Legs (incl. gluteal)
integer
C4526045 (UMLS CUI [1])
Erythema Head / Neck
Code List
Induration Legs (incl. gluteal)
CL Item
none (0)
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
CL Item
very severe (4)
Item
Desquamation Head / Neck
integer
C4526025 (UMLS CUI [1])
Erythema Head / Neck
Code List
Desquamation Head / Neck
CL Item
none (0)
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
CL Item
very severe (4)
Item
Desquamation Arms
integer
C4526039 (UMLS CUI [1])
Erythema Head / Neck
Code List
Desquamation Arms
CL Item
none (0)
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
CL Item
very severe (4)
Item
Desquamation Trunk (incl. axillae + groins)
integer
C4526032 (UMLS CUI [1])
Erythema Head / Neck
Code List
Desquamation Trunk (incl. axillae + groins)
CL Item
none (0)
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
CL Item
very severe (4)
Item
Desquamation Legs (incl. gluteal)
integer
C4526046 (UMLS CUI [1])
Erythema Head / Neck
Code List
Desquamation Legs (incl. gluteal)
CL Item
none (0)
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
CL Item
very severe (4)
Subtotal A1
Item
Subtotal A1: Head/Neck
integer
C4526026 (UMLS CUI [1])
Subtotal A2
Item
Subtotal A2: Arms
integer
C4526040 (UMLS CUI [1])
Subtotal A3
Item
Subtotal A3: Trunk
integer
C4526033 (UMLS CUI [1])
Subtotal A4
Item
Subtotal A4: Legs
integer
C4526047 (UMLS CUI [1])
Item
Affected Area Head / Neck
integer
C4526027 (UMLS CUI [1])
Affected Area Head / Neck
Code List
Affected Area Head / Neck
CL Item
0% (0)
CL Item
<10% (1)
CL Item
≥10-29% (2)
CL Item
≥30-49% (3)
CL Item
≥50-69% (4)
CL Item
≥70-89% (5)
CL Item
≥90-100% (6)
Item
Affected Area Arms
integer
C4526041 (UMLS CUI [1])
Affected Area Head / Neck
Code List
Affected Area Arms
CL Item
0% (0)
CL Item
<10% (1)
CL Item
≥10-29% (2)
CL Item
≥30-49% (3)
CL Item
≥50-69% (4)
CL Item
≥70-89% (5)
CL Item
≥90-100% (6)
Item
Affected Area Trunk (incl. axillae + groins)
integer
C4526034 (UMLS CUI [1])
Affected Area Head / Neck
Code List
Affected Area Trunk (incl. axillae + groins)
CL Item
0% (0)
CL Item
<10% (1)
CL Item
≥10-29% (2)
CL Item
≥30-49% (3)
CL Item
≥50-69% (4)
CL Item
≥70-89% (5)
CL Item
≥90-100% (6)
Item
Affected Area Legs (incl. gluteal)
integer
C4526041 (UMLS CUI [1])
Affected Area Head / Neck
Code List
Affected Area Legs (incl. gluteal)
CL Item
0% (0)
CL Item
<10% (1)
CL Item
≥10-29% (2)
CL Item
≥30-49% (3)
CL Item
≥50-69% (4)
CL Item
≥70-89% (5)
CL Item
≥90-100% (6)
Subtotal B1
Item
Subtotal B1: Head/Neck
integer
C4526028 (UMLS CUI [1])
Subtotal B2
Item
Subtotal B2: Arms
integer
C4526042 (UMLS CUI [1])
Subtotal B3
Item
Subtotal B3: Trunk (incl. axillae + groins)
integer
C4526035 (UMLS CUI [1])
Subtotal B4
Item
Subtotal B4: Legs (incl. gluteal)
integer
C4526049 (UMLS CUI [1])
Subtotal C1
Item
Subtotal C1: Head/Neck
float
C4526029 (UMLS CUI [1])
Subtotal C2
Item
Subtotal C2: Arms
float
C4526043 (UMLS CUI [1])
Subtotal C3
Item
Subtotal C3: Trunk (incl. axillae + groins)
float
C4526036 (UMLS CUI [1])
Subtotal C4
Item
Subtotal C4: Legs (incl. gluteal)
float
C4526050 (UMLS CUI [1])
PASI Total
Item
PASI Total Score
float
C4526051 (UMLS CUI [1])
Total Body Surface Area with Psoriasis
Item
Total Body Surface Area with Psoriasis
integer
C0005902 (UMLS CUI [1,1])
C0033860 (UMLS CUI [1,2])
Signature date
Item
Signature date
date
C0807937 (UMLS CUI [1])
PASI Comments
Item
PASI Comments
text
C4528685 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
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