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ID
42660
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 This form belongs to Primary CRF, inpatient surveillance,documentation of adverse and serious adverse events. Attachment 14 is used for documentation of therapy toxicity.
Keywords
Versions (3)
- 11/19/15 11/19/15 -
- 9/17/21 9/17/21 -
- 11/18/21 11/18/21 -
Uploaded on
September 17, 2021
DOI
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License
Creative Commons BY-NC 3.0
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Toxicity- Form Hyperthermia treatment Study
Toxicity-Form Hyper-PEI (modified WHO CTC)
- StudyEvent: ODM
Similar models
Toxicity-Form Hyper-PEI (modified WHO CTC)
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Patient Name
Item
Patient Name
text
C1299487 (UMLS CUI [1])
Hyper-PEI-UPN
Item
Hyper-PEI-UPN
text
Attachment
Item
To be enclosed to
integer
C1999228 (UMLS CUI [1])
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])
G-CSF
Item
Administering of G-CSF
text
C0079459 (UMLS CUI [1])
Start time
Item
Start time
time
C1301880 (UMLS CUI [1])
End time
Item
End time
time
C1522314 (UMLS CUI [1])
Medication name
Item
Specify medication used:
text
C2360065 (UMLS CUI [1])
Dosage
Item
Dosage
float
C0178602 (UMLS CUI [1])
Erythrocyte concentrate
Item
Amount of erythrocyte concentrate administered
integer
C0086252 (UMLS CUI [1])
Erythrocyte concentrate
Item
Date of latest Transfusion
date
C0199962 (UMLS CUI [1])
Platelet concentrate
Item
Amount of Platelet concentrate administered
integer
C1293886 (UMLS CUI [1])
Platelet concentrate
Item
Date of latest platelet transfusion
date
C1293886 (UMLS CUI [1])
Item
Allergic reaction or hypersensitivity
text
C1527304|C0020517 (UMLS CUI [1])
CL Item
none , 1=transient erythema/drug fever <38°C , 2=urticaria/drug fever ≤ 38°C /mild bronchial spasm 3=serum sickness/bronchial spasms/parenteral therapy necessary , 4=anaphylaxis (0)
CL Item
1 , 2=2, 3=3, 4=4 (1)
CL Item
normal , 2=symptoms without impairment of ADL , 3=symptoms, ADL impaired (0)
CL Item
normal , 1=hearing loss only to be determined audiometrically , 2=moderate symptoms of tinnitus,mild hypacusis in audiometric testing , 3=severely impairing hearing loss,hearing aid required , 4=irreversible deafness (0)
CL Item
no hearing loss (0)
CL Item
≤ 15dB at ≤ 2kHz (1)
CL Item
16-30dB at ≤ 2kHz (2)
CL Item
31-60dB at ≤ 2kHz (3)
CL Item
>60dB at ≤ 2kHz (4)
Cushingoid symptoms
Item
Cushingoid symptoms
boolean
C1559204 (UMLS CUI [1])
CL Item
none , 1=asymptomatic/no treatment required , 2=symptomatic/treatment required , 3=hospitalization associated with hypothyroidism , 4=myxedema coma (0)
Inappropriate ADH Syndrome
Item
Inappropriate ADH Syndrome
boolean
C0021141 (UMLS CUI [1])
CL Item
none (0)
CL Item
almost normal eating (1)
CL Item
severely reduced food intake but still eating (2)
CL Item
almost no food intake (3)
CL Item
none (0)
CL Item
1 episode/24h (1)
CL Item
2-5 episodes/24h (2)
CL Item
6-10 episodes/24h (3)
CL Item
>10 episodes/24h or parenteral antiemesis (4)
CL Item
none (0)
CL Item
>2-3 bowel movements/day (1)
CL Item
≥4-6 bowel movements/day, nightly tenesmus,moderate tenesmus at daytime (2)
CL Item
≥7-9 bowel movements/day, severe tenesmus,incontinence (3)
CL Item
≥10 bowel movements/day, bloody diarrhea, i.v infusions required (4)
CL Item
normal (0)
CL Item
slightly altered (1)
CL Item
severly altered (2)
CL Item
irreversibly altered (4)
CL Item
normal (0)
CL Item
slightly altered (1)
CL Item
severly altered (2)
CL Item
irreversibly altered (4)
CL Item
Not At All (0)
CL Item
A Little Bit (1)
CL Item
Somewhat (2)
CL Item
Quite A Bit (3)
CL Item
Ileus>96h (4)
CL Item
none (0)
CL Item
increased frequency of bowel movement,blood spots (1)
CL Item
increased frequency of bowel movement,bloody feces (2)
CL Item
diarrhea,severly bloody and mucous feces, parenteral substitution required (3)
CL Item
perforation,bleeding,necrosis,other life threatening complication (4)
CL Item
none (0)
CL Item
mild, no pRBC´s required (1)
CL Item
pRBC required (3)
CL Item
life threatening bleeding,ICU required (4)
CL Item
normal (0)
CL Item
≤ 1.66 ULN (1)
CL Item
≤ 2.33 ULN (2)
CL Item
≤ 3.00 ULN (3)
CL Item
>3.00 ULN (4)
CL Item
none (0)
CL Item
some (1)
CL Item
petechiae and purpura in larger area (2)
CL Item
generalised petechiae and purpura in skin and/or mucous membrane (4)
CL Item
normal (0)
CL Item
≤ 1.25 ULN (1)
CL Item
≤ 1.50 ULN (2)
CL Item
≤ 2.00 ULN (3)
CL Item
> 2.00 ULN (4)
CL Item
3.0-3.900 (1)
CL Item
≥4000 (0)
CL Item
2.0-2.900 (2)
CL Item
1.0-1.900 (3)
CL Item
<1000 (4)
CL Item
normal (0)
CL Item
≥75.000 (1)
CL Item
<75.000 (2)
CL Item
<50.000 (3)
CL Item
<25.000 (4)
CL Item
normal (0)
CL Item
≥10 (1)
CL Item
<10 (2)
CL Item
<8 (3)
CL Item
<6,5 (4)
CL Item
≥ 2.000 (0)
CL Item
< 2.000 (1)
CL Item
< 1.500 (2)
CL Item
< 1.000 (3)
CL Item
< 500 (4)
CL Item
> 2.000 1=< 2.000 2=< 1.500 3=< 1.000 4=< 500 (0)
CL Item
none (0)
CL Item
little,no pRBC required (1)
CL Item
severe,1-2 pRBC/episode (2)
CL Item
very severe, 3-4 pRBC/episode (3)
CL Item
massive,>4 pRBC/episode (4)
CL Item
none (0)
CL Item
local (1)
CL Item
severe/complete (2)
CL Item
none (0)
CL Item
macular/papular exanthema (1)
CL Item
macular/papular erythema with pruritus on 50% of body surface (2)
CL Item
generalised erythroderma/macular-papular or vesicular eruptions >50% body surface (3)
CL Item
generalised exfoliative/ulcerative dermatitis (4)
CL Item
none (0)
CL Item
painless ulceration/erythema (1)
CL Item
painful erythema/edema/ulceration, but still able to eat (2)
CL Item
painful erythema/edema/ulceration, unable to eat (3)
CL Item
parenteral or enteral nutrition required (4)
CL Item
none (0)
CL Item
no treatment required (1)
CL Item
topical or systemic treatment < 24h required (2)
CL Item
systemic treatment > 24h required (3)
CL Item
none (0)
CL Item
cellulitis (1)
CL Item
superficial infection (2)
CL Item
iv antibiotics required (3)
CL Item
necrotizing fasciitis (4)
CL Item
none (0)
CL Item
suture dehiscence (1)
CL Item
suture hernia (2)
CL Item
fasciotomy (3)
CL Item
fasciotomy with exposure of inner organs (4)
CL Item
none (0)
CL Item
°I (painful rash and swelling) (1)
CL Item
°II (blistering,exuding skin-lesion) (2)
CL Item
°III (blistering,white-grey necrosis of dermis and subdermis,no pain,no epithelial regeneration (3)
CL Item
°IV (no regeneration, charring) (4)
Item
Burns classified according to percentage of body surface involved or size of burn blister
text
C0433219 (UMLS CUI [1,1])
C2003948 (UMLS CUI [1,2])
C2003948 (UMLS CUI [1,2])
Code List
Burns classified according to percentage of body surface involved or size of burn blister
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
normal (0)
CL Item
asymtomatic,transient,no treatment required (1)
CL Item
reoccuring or persisting,no treatment required (2)
CL Item
antiarrhythmical treatment required (3)
CL Item
hypotension, ventricular tachycardy,ventricular fibrillation (4)
CL Item
normal (0)
CL Item
asymptomatic reduction of resting ef <20% from baseline (1)
CL Item
asymptomatic reduction of resting ef >20% from baseline (2)
CL Item
moderate heart failure, not refractory to treatment (3)
CL Item
severe heart failure (4)
CL Item
none (0)
CL Item
asymptomatic (1)
CL Item
treatment required but no hospitalization (2)
CL Item
hospitalization,no long-term effects (3)
CL Item
shock (4)
CL Item
none (0)
CL Item
asymptomatic (1)
CL Item
treatment required (2)
CL Item
difficult treatment, impairing (3)
CL Item
anasarca (4)
Item
Pericardial effusion or Pericarditis
text
C0031039 (UMLS CUI [1,1])
C1963211 (UMLS CUI [1,2])
C1963211 (UMLS CUI [1,2])
CL Item
none (0)
CL Item
asymptomatic effusion, no intervention required (1)
CL Item
Pericarditis (pain,ecg-alterations...) (2)
CL Item
symptomatic effusion,drainage required (3)
CL Item
pericardial tamponade, immediate intervention required (4)
CL Item
none (0)
CL Item
minor, no treatment required (1)
CL Item
local infection,local or oral treatment sufficient (2)
CL Item
severe,systemic infection, iv antibiotics/antimycotics required, hospitalization (3)
CL Item
life threatening sepsis (4)
CL Item
none (0)
CL Item
minor (1)
CL Item
major (2)
CL Item
severe (3)
CL Item
lifethreatening sepsis (4)
CL Item
normal (0)
CL Item
pH≤ normal but >7,3 (1)
CL Item
pH<7,3 (3)
CL Item
pH<7,3 and lifethreatening (4)
CL Item
normal (0)
CL Item
≥ normal but < 7,5 (1)
CL Item
pH < 7,5 (3)
CL Item
< 7,5 and lifethreatening (4)
CL Item
<116 (0)
CL Item
≤160 (1)
CL Item
≤250 (2)
CL Item
≤500 (3)
CL Item
>500 (4)
CL Item
>64 (0)
CL Item
≤64 (1)
CL Item
≤54 (2)
CL Item
≤39 (3)
CL Item
<30 (4)
CL Item
<10,6 (0)
CL Item
10,0-11,5 (1)
CL Item
11,6-12,5 (2)
CL Item
12,6-13,4 (3)
CL Item
13,5 (4)
CL Item
>8,4 (0)
CL Item
8,4-7,8 (1)
CL Item
7,7-7,0 (2)
CL Item
6,9-6,1 (3)
CL Item
6,0 (4)
CL Item
>1,4 (0)
CL Item
1,4-1,2 (1)
CL Item
1,1-0,9 (2)
CL Item
0,8-0,6 (3)
CL Item
0,5 (4)
CL Item
0 (0)
CL Item
ULN-150mmol/l (1)
CL Item
>150-155mmol/l (2)
CL Item
>155-160mmol/l (3)
CL Item
>160mmol/l (4)
CL Item
LSV-130mmol/l (1)
CL Item
120-130mmol/l (3)
CL Item
<120mmol/l (4)
CL Item
>ULN-5,5mmol/l (1)
CL Item
>5,5-6,0mmol/l (2)
CL Item
>6,0-7,0mmol/l (3)
CL Item
>7,0mmol/l (4)
CL Item
<LSV-3,0 mmol/l (1)
CL Item
2,5-<3,0 mmol/l (3)
CL Item
<2,5 mmol/l (4)
CL Item
unchanged (0)
CL Item
asymptomatic,change in functional parameter (1)
CL Item
minor dyspnea on exertion (2)
CL Item
severe dyspnea on exertion (3)
CL Item
dyspnea at rest (4)
CL Item
normal (0)
CL Item
minor lymph edema (1)
CL Item
major lymph edema, compression required (2)
CL Item
severe lymph edema, functional impairment (3)
CL Item
severe lymph edema, functional impairment,ulceration (4)
CL Item
normal (0)
CL Item
<1,5 times ULN (1)
CL Item
>1,5 times ULN (2)
CL Item
> 3 times ULN (3)
CL Item
>6 times ULN (4)
CL Item
none (0)
CL Item
<0,3g/l (1)
CL Item
3-10g/l (2)
CL Item
>10g/l (3)
CL Item
nephrotic syndrome (4)
CL Item
none (0)
CL Item
microhaematuria (1)
CL Item
haematuria or blood clots (2)
CL Item
haematuria with blood clots (3)
CL Item
pRBC required (4)
CL Item
none (0)
CL Item
minor pain,no functional impairment (1)
CL Item
distinct pain,functional impairment, no impairment of ADL (2)
CL Item
severe pain,impairment to ADL (3)
CL Item
bed-ridden (4)
CL Item
unchanged (0)
CL Item
mild paresthesia,loss of deep tendon reflexes (1)
CL Item
moderate objective sensory deficit,moderate paresthesia (2)
CL Item
severe objective sensory deficit or paresthesia with functional impairment (3)
CL Item
unchanged (0)
CL Item
subjective weakness without objective finding (1)
CL Item
moderate objective weakness without significant functional impairment (2)
CL Item
objective weakness with functional impairment (3)
CL Item
paralysis (4)
CL Item
unchanged (0)
CL Item
minor anxiety or depression (1)
CL Item
moderate anxiety or depression (2)
CL Item
severe anxiety or depression (3)
CL Item
suicidal (4)
CL Item
none (0)
CL Item
minor (1)
CL Item
moderate or transient (2)
CL Item
permantly and severely (3)
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
normal , 1=weariness without impairment of ADL , 2=abnormal fatigue,impaired ADL (20% Lansky/Karnofsky) , 3=severe fatigue or loss of skills (40% Lansky/Karnofsky) , 4= bed-ridden (0)
CL Item
none , 1=38-39 , 2=39.1-40 , 3=>40<24h , 4=>40>24h (0)
CL Item
none , 1=38-39 , 2=39.1-40 , 3=>40<24h , 4=>40>24h (0)
CL Item
none , 1=38-39 , 2=39.1-40 , 3=>40<24h , 4=>40>24h (0)
CL Item
<5% , 1=5-10% , 2=10-20% , 3=>20% (0)
CL Item
<5% , 1=5-10% , 2=10-20% , 3=>20% (0)
CL Item
none , 1=mild/symptomatic therapy sufficient , 2= severe/anesthesia required , 3=no response to anesthesia (0)
CL Item
normal , 1=little/sometimes , 2=severe/frequently , 3=severe/permanently (0)