ID

12443

Description

Hyper-PEI-protocol:a programme with regional deep hyperthermia(RHT)in combination with PEI-chemotherapy.The Hyper-PEI protocol is offered in place of the intensive standard chemotherapy for high-risk patie nts with malignant, extracranial tumors. Patients have a measurable relapsed tumor,or a primary tumor that did not respond sufficiently to treatment according to standard protocols. Responsible MD: PD Dr. med. R Wessalowski, Clinic for pediatric oncology,haematology and immunology UKD, Moorenstr. 5, 40225 Dusseldorf Only to be filled in if current SAE have been observed. To be faxed workdays to Study-coordinator within 24h after observation. 0211-811-9198 Study-coordinator will inform BfArM and ethics committee about any deaths after inquiry within 7 days. Any other SAE will be related within 14 days.

Keywords

Versions (1)
  1. 11/19/15 11/19/15 - Julian Varghese
Uploaded on

November 19, 2015

DOI

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License

Creative Commons BY-NC 3.0
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Severe adverse Events (SAE) Form Hyperthermia Treatment Study

English

Severe adverse Events (SAE) Hyper-PEI

1 forms  
Identification
Description

Identification

Patient ID
Description

Patient Identification

Data type

text

Alias
UMLS CUI [1]
C1269815
Hyper-PEI-UPN
Description

Hyper-PEI-UPN

Data type

text

Observed SAE
Description

Observed SAE

Death within 30 days of treatment
Description

Death

Data type

boolean

Alias
UMLS CUI [1]
C1306577
Lifethreatening adverse event (i.e Toxicity-level 4 WHO)
Description

Lifethreatening

Data type

boolean

Alias
UMLS CUI [1]
C1517874
Permanently disabling or crippling adverse event
Description

Disabling AE

Data type

boolean

Alias
UMLS CUI [1]
C3830477
AE requires or prolongs hospitalization
Description

Hospitalization

Data type

boolean

Alias
UMLS CUI [1]
C2826664
Secondary Neoplasm
Description

Secondary neoplasm

Data type

boolean

Alias
UMLS CUI [1]
C2939419
SAE associated with overdose causing symptoms
Description

Overdose

Data type

boolean

Alias
UMLS CUI [1]
C4018909
Specify
Description

Specify

Data type

text

Alias
UMLS CUI [1]
C1521902
Correctness of information confirmed
Description

Correctness of information confirmed

Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Treating Physician
Description

Physician

Data type

text

Alias
UMLS CUI [1]
C1710470
Signature
Description

Responsible Person Signature

Data type

text

Alias
UMLS CUI [1]
C1550483
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Similar models

Severe adverse Events (SAE) Hyper-PEI

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Identification
Patient Identification
Item
Patient ID
text
C1269815 (UMLS CUI [1])
Hyper-PEI-UPN
Item
Hyper-PEI-UPN
text
Item Group
Observed SAE
Death
Item
Death within 30 days of treatment
boolean
C1306577 (UMLS CUI [1])
Lifethreatening
Item
Lifethreatening adverse event (i.e Toxicity-level 4 WHO)
boolean
C1517874 (UMLS CUI [1])
Disabling AE
Item
Permanently disabling or crippling adverse event
boolean
C3830477 (UMLS CUI [1])
Hospitalization
Item
AE requires or prolongs hospitalization
boolean
C2826664 (UMLS CUI [1])
Secondary neoplasm
Item
Secondary Neoplasm
boolean
C2939419 (UMLS CUI [1])
Overdose
Item
SAE associated with overdose causing symptoms
boolean
C4018909 (UMLS CUI [1])
Specify
Item
Specify
text
C1521902 (UMLS CUI [1])
Item Group
Correctness of information confirmed
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Physician
Item
Treating Physician
text
C1710470 (UMLS CUI [1])
Responsible Person Signature
Item
Signature
text
C1550483 (UMLS CUI [1])
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