ID

18562

Description

Positronen-Emissionstomographie-gesteuerte Therapie aggressiver Non-Hodgkin-Lymphome (PETAL-Studie) Universitätsklinikum Essen (UK Essen) EudraCT-Nummer: 2006-001641-33 NCT00554164

Keywords

  1. 11/10/16 11/10/16 -
  2. 11/10/16 11/10/16 -
  3. 9/20/21 9/20/21 -
Uploaded on

November 10, 2016

DOI

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License

Creative Commons BY-NC 3.0

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PETAL Study NCT00554164

(R)-DHAP

  1. StudyEvent: ODM
    1. (R)-DHAP
Untersuchungsinformationen
Description

Untersuchungsinformationen

Untersuchungs-/Therapiedatum
Description

Treatment date

Data type

date

Alias
UMLS CUI [1]
C3173309
Größe
Description

Patient height

Data type

float

Measurement units
  • cm
Alias
UMLS CUI [1]
C0489786
cm
Gewicht
Description

Patient weight

Data type

float

Alias
UMLS CUI [1]
C0005910
Körperoberfläche
Description

Body surface

Data type

float

Alias
UMLS CUI [1]
C0005902
Dosisreduktion bei Übergewicht
Description

Dosage reduction overweight

Data type

boolean

Alias
UMLS CUI [1,1]
C0441610
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0497406
Therapiezeiten
Description

Therapiezeiten

1. Tag der (Vorphase/Chemo)Therapie
Description

Date of Therapy

Data type

date

Alias
UMLS CUI [1]
C1707637
Tag der Rituximab-Gabe
Description

Rituximab

Data type

date

Measurement units
  • days
Alias
UMLS CUI [1,1]
C0393022
UMLS CUI [1,2]
C1316946
days
Dosierung der Chemotherapeutika in diesem Zyklus
Description

Dosierung der Chemotherapeutika in diesem Zyklus

Alias
UMLS CUI-1
C0392920
UMLS CUI-2
C0178602
Dexamethason
Description

Dexamethason

Data type

integer

Measurement units
  • mg
Alias
UMLS CUI [1]
C0011777
mg
Rituximab
Description

Rituximab

Data type

integer

Measurement units
  • mg
Alias
UMLS CUI [1]
C0393022
mg
Cytosinarabinosid
Description

Cytosinarabinosid

Data type

float

Alias
UMLS CUI [1]
C0010711
Cisplatin
Description

Cisplatin

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1]
C0008838
mg
Intrathekale Therapie
Description

Intrathekale Therapie

Alias
UMLS CUI-1
C1831734
MTX i.th., Dosis
Description

MTX

Data type

integer

Measurement units
  • mg
Alias
UMLS CUI [1]
C0025677
mg
MTX i.th. am
Description

MTX date of application

Data type

date

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0011008
Cytarabin i.th., Dosis
Description

Cytarabin

Data type

integer

Measurement units
  • mg
Alias
UMLS CUI [1]
C0010711
mg
Cytarabin i.th. am
Description

Cytarabin date

Data type

date

Alias
UMLS CUI [1,1]
C0010711
UMLS CUI [1,2]
C0011008
Supportivtherapie
Description

Supportivtherapie

Antibiotika-Prophylaxe
Description

Antibiotic Prophylaxis

Data type

boolean

Alias
UMLS CUI [1]
C0282638
Antibiotika-Prophylaxe, Anzahl Tage
Description

Pre-operative antibiotic prophylaxis administered

Data type

integer

Measurement units
  • days
Alias
UMLS CUI [1]
C2114165
days
Antibiotika-Therapie
Description

Antibiotic therapy

Data type

boolean

Alias
UMLS CUI [1]
C0338237
Antibiotika-Therapie, Anzahl Tage
Description

Antibiotic therapy duration

Data type

integer

Measurement units
  • days
Alias
UMLS CUI [1,1]
C0338237
UMLS CUI [1,2]
C0444917
days
Thrombozyten-Transfusion
Description

Platelet function

Data type

boolean

Alias
UMLS CUI [1]
C1254881
Anzahl Konz.
Description

Platelet concentrate

Data type

integer

Alias
UMLS CUI [1]
C1294041
Erythrozyten-Transfusion
Description

Red Blood Cell Transfusion

Data type

boolean

Alias
UMLS CUI [1]
C0086252
Anzahl Ery Konz.
Description

Blood erythrocyte concentration

Data type

integer

Alias
UMLS CUI [1]
C0522048
Erythropoetin
Description

Erythropoetin

Data type

boolean

Alias
UMLS CUI [1]
C0014822
Erythropoetin, Dosis
Description

Erythropoetin, Dosage

Data type

integer

Alias
UMLS CUI [1]
C0014822
Parenterale Ernährung
Description

Parenteral Nutrition

Data type

boolean

Alias
UMLS CUI [1]
C0030547
Pareenterale Therapie, Anzahl Tage
Description

Parenteral Nutrition, Total

Data type

integer

Measurement units
  • days
Alias
UMLS CUI [1]
C0030548
days
Analgetika (Mukositis)
Description

Analgesics

Data type

boolean

Alias
UMLS CUI [1]
C0002771
Analgetika (Mukositis) Anzahl Tage
Description

Analgesics duration

Data type

integer

Measurement units
  • days
Alias
UMLS CUI [1,1]
C0002771
UMLS CUI [1,2]
C0444917
days
Sonstiges, was?
Description

Other

Data type

text

Alias
UMLS CUI [1]
C0205394
Ort der Verabreichung
Description

Ort der Verabreichung

Alias
UMLS CUI-1
C3469597
Ambulant
Description

Outpatients

Data type

boolean

Alias
UMLS CUI [1]
C0029921
Anz. Tage Ambulant
Description

Duration of therapy outpatient

Data type

integer

Measurement units
  • days
Alias
UMLS CUI [1,1]
C0029921
UMLS CUI [1,2]
C0444917
days
Stationär
Description

Stationary

Data type

boolean

Alias
UMLS CUI [1]
C0439835
Anz. Tage Stationär
Description

Stationary duration

Data type

integer

Measurement units
  • days
Alias
UMLS CUI [1,1]
C0444917
UMLS CUI [1,2]
C0444917
days
Komorbidität bei Therapiebeginn
Description

Komorbidität bei Therapiebeginn

Nr. Komorbidität
Description

Number Comorbidity

Data type

integer

Alias
UMLS CUI [1]
C0009488
Beschreibung Begleiterkrankung
Description

Description Comorbidity

Data type

text

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C0009488
Komorbidität seit
Description

Comorbidity length

Data type

text

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0872146
Dauermedikation bei Therapiebeginn
Description

Dauermedikation bei Therapiebeginn

Alias
UMLS CUI-1
C2826814
Nr. der Medikation
Description

Number of medication

Data type

integer

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0449788
Name der Medikation
Description

Medication Name

Data type

text

Alias
UMLS CUI [1]
C2360065
Indikation
Description

Indication

Data type

text

Alias
UMLS CUI [1]
C3146298
G-CSF
Description

G-CSF

Alias
UMLS CUI-1
C0796404
G-CSF?
Description

G-CSF?

Data type

boolean

Alias
UMLS CUI [1]
C0079459
PEG-Filgrastim
Description

PEG-Filgrastim date

Data type

date

Alias
UMLS CUI [1,1]
C0210630
UMLS CUI [1,2]
C0011008
Filgrastim, Dosis
Description

Filgrastim dosage

Data type

integer

Measurement units
  • μg tgl.
Alias
UMLS CUI [1,1]
C0210630
UMLS CUI [1,2]
C0178602
μg tgl.
Filgrastim, Anzahl Tage
Description

Filgrastim Duration of treatment

Data type

integer

Measurement units
  • days
Alias
UMLS CUI [1,1]
C0210630
UMLS CUI [1,2]
C0444921
days
Zyklusdauer
Description

Zyklusdauer

Intervall Tag 1 - Tag 1
Description

Interval

Data type

integer

Alias
UMLS CUI [1]
C1272706
Grund für Intervallverlängerung
Description

Reason for prolonged interval

Data type

integer

Alias
UMLS CUI [1]
C1272706
Vorzeitiger Therapieabbruch?
Description

Vorzeitiger Therapieabbruch?

Therapieabbruch
Description

Therapy discontinuation

Data type

boolean

Alias
UMLS CUI [1]
C0677162
Progressive Disease
Description

Progressive Disease

Data type

boolean

Alias
UMLS CUI [1]
C1335499
Toxizität
Description

Drug toxicity

Data type

boolean

Alias
UMLS CUI [1]
C0013221
Patientenwunsch
Description

Patient wish

Data type

boolean

Alias
UMLS CUI [1]
C0747309
Sonstiges
Description

Other

Data type

boolean

Alias
UMLS CUI [1]
C0205394
Stammzellmobilisierung
Description

Stammzellmobilisierung

Stammzellmobilisierung
Description

Stem Cell Mobilization

Data type

boolean

Alias
UMLS CUI [1]
C0524864
CD34-Zellen pro kg KG
Description

CD34 stem cell count procedure

Data type

integer

Measurement units
  • pro kg KG
Alias
UMLS CUI [1]
C1277788
pro kg KG
Labor unmittelbar vor dem Zyklus
Description

Labor unmittelbar vor dem Zyklus

Alias
UMLS CUI-1
C1302181
Hämoglobin
Description

HB

Data type

float

Alias
UMLS CUI [1]
C0518015
Leukozyten
Description

Leucocytes

Data type

float

Alias
UMLS CUI [1]
C0023508
Granulozyten
Description

Granulocytes

Data type

float

Alias
UMLS CUI [1]
C0857490
Thrombozyten
Description

Thrombocytes

Data type

float

Alias
UMLS CUI [1]
C0005821
Kreatinin
Description

Creatinin

Data type

float

Alias
UMLS CUI [1]
C0201976
Bilirubin
Description

Bilirubin

Data type

float

Alias
UMLS CUI [1]
C1278039
C-reaktives Protein
Description

C-reactives Proteine

Data type

float

Alias
UMLS CUI [1]
C0006560
Sonstiges
Description

Other

Data type

float

Labor im Intervall nach dem Zyklus 1
Description

Labor im Intervall nach dem Zyklus 1

Zyklustag
Description

Chemotherapy cycle

Data type

text

Alias
UMLS CUI [1,1]
C1302181
UMLS CUI [1,2]
C3468389
HB
Description

HB

Data type

float

Alias
UMLS CUI [1]
C0518015
Leukozyten
Description

Leucocytes

Data type

float

Alias
UMLS CUI [1]
C0023508
Granulozyten
Description

Granulocyte count

Data type

float

Alias
UMLS CUI [1]
C0857490
Thrombozyten
Description

Thrombozctes

Data type

float

Alias
UMLS CUI [1]
C1287267
Toxizitäten
Description

Toxizitäten

Alias
UMLS CUI-1
C0013221
Kreatinin
Description

Creatinin

Data type

integer

Alias
UMLS CUI [1]
C0201976
Übelkeit
Description

Nausea

Data type

float

Alias
UMLS CUI [1]
C0027497
Erbrechen
Description

Vomiting

Data type

integer

Alias
UMLS CUI [1]
C0042963
Diarrhoe
Description

Diarrhoe

Data type

integer

Alias
UMLS CUI [1]
C0011991
Stomatitis
Description

Stomatitis

Data type

integer

Alias
UMLS CUI [1]
C0038362
Obstipation
Description

Obstipation

Data type

integer

Alias
UMLS CUI [1]
C1963087
Mucositis
Description

Stomatitis

Data type

integer

Alias
UMLS CUI [1]
C0038362
Hämorrhagische Zystitis
Description

Hemorrhagic cystitis

Data type

integer

Alias
UMLS CUI [1]
C0085692
Sensorium
Description

Level of consciousness

Data type

integer

Alias
UMLS CUI [1]
C0234425
Alopezie
Description

Alopezie

Data type

integer

Alias
UMLS CUI [1]
C1559115
Infektion
Description

Infection

Data type

integer

Alias
UMLS CUI [1]
C0009450
Toxizität, sonstiges
Description

Toxicity

Data type

integer

Alias
UMLS CUI [1]
C0013221
Interkurrente Erkrankung
Description

Interkurrente Erkrankung

Alias
UMLS CUI-1
C0277557
Interkurrente Erkrankung?
Description

Intercurrent disease

Data type

boolean

Alias
UMLS CUI [1]
C0277557
Arzt Datum und Unterschrift
Description

Arzt Datum und Unterschrift

Weiteres Vorgehen - Kommentar
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Datum der Bearbeitung
Description

Date of processing

Data type

date

Alias
UMLS CUI [1]
C1709694
Unterschrift Prüfarzt (vorhanden?)
Description

Signature clinical investigator

Data type

boolean

Alias
UMLS CUI [1]
C0008961

Similar models

(R)-DHAP

  1. StudyEvent: ODM
    1. (R)-DHAP
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Untersuchungsinformationen
Treatment date
Item
Untersuchungs-/Therapiedatum
date
C3173309 (UMLS CUI [1])
Patient height
Item
Größe
float
C0489786 (UMLS CUI [1])
Patient weight
Item
Gewicht
float
C0005910 (UMLS CUI [1])
Body surface
Item
Körperoberfläche
float
C0005902 (UMLS CUI [1])
Dosage reduction overweight
Item
Dosisreduktion bei Übergewicht
boolean
C0441610 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0497406 (UMLS CUI [1,3])
Item Group
Therapiezeiten
Date of Therapy
Item
1. Tag der (Vorphase/Chemo)Therapie
date
C1707637 (UMLS CUI [1])
Rituximab
Item
Tag der Rituximab-Gabe
date
C0393022 (UMLS CUI [1,1])
C1316946 (UMLS CUI [1,2])
Item Group
Dosierung der Chemotherapeutika in diesem Zyklus
C0392920 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
Dexamethason
Item
Dexamethason
integer
C0011777 (UMLS CUI [1])
Rituximab
Item
Rituximab
integer
C0393022 (UMLS CUI [1])
Cytosinarabinosid
Item
Cytosinarabinosid
float
C0010711 (UMLS CUI [1])
Cisplatin
Item
Cisplatin
float
C0008838 (UMLS CUI [1])
Item Group
Intrathekale Therapie
C1831734 (UMLS CUI-1)
MTX
Item
MTX i.th., Dosis
integer
C0025677 (UMLS CUI [1])
MTX date of application
Item
MTX i.th. am
date
C0025677 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Cytarabin
Item
Cytarabin i.th., Dosis
integer
C0010711 (UMLS CUI [1])
Cytarabin date
Item
Cytarabin i.th. am
date
C0010711 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Supportivtherapie
Antibiotic Prophylaxis
Item
Antibiotika-Prophylaxe
boolean
C0282638 (UMLS CUI [1])
Pre-operative antibiotic prophylaxis administered
Item
Antibiotika-Prophylaxe, Anzahl Tage
integer
C2114165 (UMLS CUI [1])
Antibiotic therapy
Item
Antibiotika-Therapie
boolean
C0338237 (UMLS CUI [1])
Antibiotic therapy duration
Item
Antibiotika-Therapie, Anzahl Tage
integer
C0338237 (UMLS CUI [1,1])
C0444917 (UMLS CUI [1,2])
Platelet function
Item
Thrombozyten-Transfusion
boolean
C1254881 (UMLS CUI [1])
Platelet concentrate
Item
Anzahl Konz.
integer
C1294041 (UMLS CUI [1])
Red Blood Cell Transfusion
Item
Erythrozyten-Transfusion
boolean
C0086252 (UMLS CUI [1])
Blood erythrocyte concentration
Item
Anzahl Ery Konz.
integer
C0522048 (UMLS CUI [1])
Erythropoetin
Item
Erythropoetin
boolean
C0014822 (UMLS CUI [1])
Erythropoetin, Dosage
Item
Erythropoetin, Dosis
integer
C0014822 (UMLS CUI [1])
Parenteral Nutrition
Item
Parenterale Ernährung
boolean
C0030547 (UMLS CUI [1])
Parenteral Nutrition, Total
Item
Pareenterale Therapie, Anzahl Tage
integer
C0030548 (UMLS CUI [1])
Analgesics
Item
Analgetika (Mukositis)
boolean
C0002771 (UMLS CUI [1])
Analgesics duration
Item
Analgetika (Mukositis) Anzahl Tage
integer
C0002771 (UMLS CUI [1,1])
C0444917 (UMLS CUI [1,2])
Other
Item
Sonstiges, was?
text
C0205394 (UMLS CUI [1])
Item Group
Ort der Verabreichung
C3469597 (UMLS CUI-1)
Outpatients
Item
Ambulant
boolean
C0029921 (UMLS CUI [1])
Duration of therapy outpatient
Item
Anz. Tage Ambulant
integer
C0029921 (UMLS CUI [1,1])
C0444917 (UMLS CUI [1,2])
Stationary
Item
Stationär
boolean
C0439835 (UMLS CUI [1])
Stationary duration
Item
Anz. Tage Stationär
integer
C0444917 (UMLS CUI [1,1])
C0444917 (UMLS CUI [1,2])
Item Group
Komorbidität bei Therapiebeginn
Number Comorbidity
Item
Nr. Komorbidität
integer
C0009488 (UMLS CUI [1])
Description Comorbidity
Item
Beschreibung Begleiterkrankung
text
C0678257 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
Comorbidity length
Item
Komorbidität seit
text
C0009488 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Item Group
Dauermedikation bei Therapiebeginn
C2826814 (UMLS CUI-1)
Number of medication
Item
Nr. der Medikation
integer
C0013227 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Medication Name
Item
Name der Medikation
text
C2360065 (UMLS CUI [1])
Indication
Item
Indikation
text
C3146298 (UMLS CUI [1])
Item Group
G-CSF
C0796404 (UMLS CUI-1)
G-CSF?
Item
G-CSF?
boolean
C0079459 (UMLS CUI [1])
PEG-Filgrastim date
Item
PEG-Filgrastim
date
C0210630 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Filgrastim dosage
Item
Filgrastim, Dosis
integer
C0210630 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Filgrastim Duration of treatment
Item
Filgrastim, Anzahl Tage
integer
C0210630 (UMLS CUI [1,1])
C0444921 (UMLS CUI [1,2])
Item Group
Zyklusdauer
Interval
Item
Intervall Tag 1 - Tag 1
integer
C1272706 (UMLS CUI [1])
Reason for prolonged interval
Item
Grund für Intervallverlängerung
integer
C1272706 (UMLS CUI [1])
Item Group
Vorzeitiger Therapieabbruch?
Therapy discontinuation
Item
Therapieabbruch
boolean
C0677162 (UMLS CUI [1])
Progressive Disease
Item
Progressive Disease
boolean
C1335499 (UMLS CUI [1])
Drug toxicity
Item
Toxizität
boolean
C0013221 (UMLS CUI [1])
Patient wish
Item
Patientenwunsch
boolean
C0747309 (UMLS CUI [1])
Other
Item
Sonstiges
boolean
C0205394 (UMLS CUI [1])
Item Group
Stammzellmobilisierung
Stem Cell Mobilization
Item
Stammzellmobilisierung
boolean
C0524864 (UMLS CUI [1])
CD34 stem cell count procedure
Item
CD34-Zellen pro kg KG
integer
C1277788 (UMLS CUI [1])
Item Group
Labor unmittelbar vor dem Zyklus
C1302181 (UMLS CUI-1)
HB
Item
Hämoglobin
float
C0518015 (UMLS CUI [1])
Leucocytes
Item
Leukozyten
float
C0023508 (UMLS CUI [1])
Granulocytes
Item
Granulozyten
float
C0857490 (UMLS CUI [1])
Thrombocytes
Item
Thrombozyten
float
C0005821 (UMLS CUI [1])
Creatinin
Item
Kreatinin
float
C0201976 (UMLS CUI [1])
Bilirubin
Item
Bilirubin
float
C1278039 (UMLS CUI [1])
C-reactives Proteine
Item
C-reaktives Protein
float
C0006560 (UMLS CUI [1])
Other
Item
Sonstiges
float
Item Group
Labor im Intervall nach dem Zyklus 1
Chemotherapy cycle
Item
Zyklustag
text
C1302181 (UMLS CUI [1,1])
C3468389 (UMLS CUI [1,2])
HB
Item
HB
float
C0518015 (UMLS CUI [1])
Leucocytes
Item
Leukozyten
float
C0023508 (UMLS CUI [1])
Granulocyte count
Item
Granulozyten
float
C0857490 (UMLS CUI [1])
Thrombozctes
Item
Thrombozyten
float
C1287267 (UMLS CUI [1])
Item Group
Toxizitäten
C0013221 (UMLS CUI-1)
Creatinin
Item
Kreatinin
integer
C0201976 (UMLS CUI [1])
Nausea
Item
Übelkeit
float
C0027497 (UMLS CUI [1])
Vomiting
Item
Erbrechen
integer
C0042963 (UMLS CUI [1])
Diarrhoe
Item
Diarrhoe
integer
C0011991 (UMLS CUI [1])
Stomatitis
Item
Stomatitis
integer
C0038362 (UMLS CUI [1])
Obstipation
Item
Obstipation
integer
C1963087 (UMLS CUI [1])
Stomatitis
Item
Mucositis
integer
C0038362 (UMLS CUI [1])
Hemorrhagic cystitis
Item
Hämorrhagische Zystitis
integer
C0085692 (UMLS CUI [1])
Level of consciousness
Item
Sensorium
integer
C0234425 (UMLS CUI [1])
Alopezie
Item
Alopezie
integer
C1559115 (UMLS CUI [1])
Infection
Item
Infektion
integer
C0009450 (UMLS CUI [1])
Toxicity
Item
Toxizität, sonstiges
integer
C0013221 (UMLS CUI [1])
Item Group
Interkurrente Erkrankung
C0277557 (UMLS CUI-1)
Intercurrent disease
Item
Interkurrente Erkrankung?
boolean
C0277557 (UMLS CUI [1])
Item Group
Arzt Datum und Unterschrift
Comment
Item
Weiteres Vorgehen - Kommentar
text
C0947611 (UMLS CUI [1])
Date of processing
Item
Datum der Bearbeitung
date
C1709694 (UMLS CUI [1])
Signature clinical investigator
Item
Unterschrift Prüfarzt (vorhanden?)
boolean
C0008961 (UMLS CUI [1])

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