ID
44713
Description
Official Title: Phase II Pharmacokinetic Study to Assess the Age-dependency in the Clearance of Doxorubicin in Paediatric Patients With Solid Tumours and Leukaemia Analyze pharmacokinetics of doxorubicin in children with cancer. Furthermore investigate the predictive role of troponin and natriuretic peptides for anthracycline-induced cardiotoxicity. https://clinicaltrials.gov/ct2/show/NCT01095926 NCT01095926
Link
https://clinicaltrials.gov/ct2/show/NCT01095926
Keywords
Versions (2)
- 11/2/15 11/2/15 -
- 9/27/21 9/27/21 -
Uploaded on
September 27, 2021
DOI
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License
Creative Commons BY 4.0
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Pharmacokinetic Study of Doxorubicin in Children With Cancer DRKS00003787 NCT01095926
1st Sampling period
- StudyEvent: ODM
Description
Determination of cardiac function (before sampling period)
Description
Date
Data type
date
Alias
- UMLS CUI [1]
- C0011008
Description
Blood pressure
Data type
integer
Measurement units
- mm Hg
Alias
- UMLS CUI [1]
- C0005823
Description
Heart rate
Data type
integer
Measurement units
- /min
Description
Echocardiography
Data type
integer
Alias
- UMLS CUI [1]
- C0013516
Description
Electrocardiography (optional)
Data type
integer
Alias
- UMLS CUI [1]
- C1623258
Description
Clinical chemistry
Description
Date
Data type
date
Alias
- UMLS CUI [1]
- C0011008
Description
Bilirubin (total)
Data type
integer
Measurement units
- mg/dL
Alias
- UMLS CUI [1]
- C0201913
Description
Serum creatinine
Data type
integer
Measurement units
- mg/dL
Alias
- UMLS CUI [1]
- C0201976
Description
Serum albumin
Data type
integer
Measurement units
- mg/dL
Description
GOT / AST
Data type
integer
Measurement units
- U/L
Alias
- UMLS CUI [1]
- C0004002
Description
GPT / ALT
Data type
integer
Measurement units
- U/L
Alias
- UMLS CUI [1]
- C0001899
Description
GFR
Data type
integer
Measurement units
- mL/min
Alias
- UMLS CUI [1]
- C0017654
Description
Haematology
Description
Date
Data type
date
Alias
- UMLS CUI [1]
- C0011008
Description
Haemoglobin
Data type
integer
Measurement units
- g/dL
Alias
- UMLS CUI [1]
- C0518015
Description
Haematocrit
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1]
- C0366777
Description
Neutrophils
Data type
integer
Measurement units
- /μL
Alias
- UMLS CUI [1]
- C0027950
Description
Leucocytes
Data type
integer
Measurement units
- /μL
Alias
- UMLS CUI [1]
- C0023508
Description
Platelets
Data type
integer
Measurement units
- /μL
Alias
- UMLS CUI [1]
- C0005821
Description
Agents that are known to interact with doxorubicin according to SmPCs administered?
Description
Carbamazepine
Data type
boolean
Alias
- UMLS CUI [1]
- C0006949
Description
Cimetidine
Data type
boolean
Alias
- UMLS CUI [1]
- C0008783
Description
Cyclosporin
Data type
boolean
Alias
- UMLS CUI [1]
- C0010592
Description
Phenobarbital
Data type
boolean
Alias
- UMLS CUI [1]
- C0031412
Description
Phenytoin
Data type
boolean
Alias
- UMLS CUI [1]
- C0031507
Description
Progesterone
Data type
boolean
Alias
- UMLS CUI [1]
- C0033308
Description
Rifampicin
Data type
integer
Alias
- UMLS CUI [1]
- C0035608
Description
Ritonavir
Data type
boolean
Alias
- UMLS CUI [1]
- C0292818
Description
Sulfamethoxazole
Data type
boolean
Alias
- UMLS CUI [1]
- C0038689
Description
Verapamil
Data type
boolean
Alias
- UMLS CUI [1]
- C0042523
Description
Antiemetic agents administered?
Description
Granisetron
Data type
boolean
Alias
- UMLS CUI [1]
- C0061863
Description
Metoclopramid
Data type
boolean
Alias
- UMLS CUI [1]
- C0025853
Description
Ondansetron
Data type
boolean
Alias
- UMLS CUI [1]
- C0061851
Description
Other 5-HT3-receptor antagonists
Data type
boolean
Alias
- UMLS CUI [1]
- C0360055
Description
Aprepitant
Data type
boolean
Alias
- UMLS CUI [1]
- C1176306
Description
Alizapride
Data type
boolean
Alias
- UMLS CUI [1]
- C0051162
Description
Dexamethason administered?
Data type
boolean
Alias
- UMLS CUI [1]
- C0011777
Description
Dimenhydrinate administered?
Data type
boolean
Alias
- UMLS CUI [1]
- C0012381
Description
Domperidone administered?
Data type
boolean
Alias
- UMLS CUI [1]
- C0013015
Description
Lorazepam administered?
Data type
boolean
Alias
- UMLS CUI [1]
- C0024002
Description
Other
Data type
boolean
Alias
- UMLS CUI [1]
- C0003297
Description
Cardioprotective agents administered?
Description
Systemic antimycotic agents
Description
Other agents administered?
Description
Antibiotic agents
Data type
boolean
Alias
- UMLS CUI [1]
- C0003232
Description
Anticonvulsive agents
Data type
boolean
Alias
- UMLS CUI [1]
- C0003286
Description
Cardioactive agents
Data type
boolean
Description
Proton pump inhibitors
Data type
boolean
Alias
- UMLS CUI [1]
- C0358591
Description
Contraceptive agents
Data type
boolean
Alias
- UMLS CUI [1]
- C0009871
Description
Systemic antiviral agents
Data type
boolean
Alias
- UMLS CUI [1]
- C0854610
Description
Actual protocol block
Description
Wilms tumour
Data type
integer
Alias
- UMLS CUI [1]
- C0027708
Description
Neuroblastoma
Data type
integer
Alias
- UMLS CUI [1]
- C0027819
Description
Ewing sarcoma
Data type
integer
Alias
- UMLS CUI [1]
- C0553580
Description
Soft tissue sarcoma
Data type
integer
Alias
- UMLS CUI [1]
- C0153561
Description
ALL
Data type
integer
Description
Other:
Data type
integer
Alias
- UMLS CUI [1]
- C0027651
Description
Start of actual protocol block
Description
Chemotherapy in actual protocol block administered ?
Description
Actinomycine D
Data type
integer
Alias
- UMLS CUI [1]
- C0010934
Description
Asparaginase
Data type
integer
Alias
- UMLS CUI [1]
- C0003993
Description
Cyclophosphamide
Data type
integer
Alias
- UMLS CUI [1]
- C0010583
Description
Dacarbazine
Data type
integer
Alias
- UMLS CUI [1]
- C0010927
Description
Dexamethasone
Data type
integer
Alias
- UMLS CUI [1]
- C0011777
Description
Etoposide
Data type
integer
Alias
- UMLS CUI [1]
- C0015133
Description
Ifosfamide
Data type
integer
Alias
- UMLS CUI [1]
- C0020823
Description
Topotecan
Data type
integer
Alias
- UMLS CUI [1]
- C0146224
Description
Vincristine
Data type
integer
Alias
- UMLS CUI [1]
- C0042679
Description
Other: (INN name)
Data type
integer
Alias
- UMLS CUI [1]
- C0729502
Description
Previous anthracycline treatment
Description
Cumulative doxorubicin dose
Data type
integer
Measurement units
- mg
Alias
- UMLS CUI [1]
- C0013089
- UMLS CUI [2]
- C2986497
Description
Other anthracyclines administered
Data type
integer
Alias
- UMLS CUI [1]
- C0282564
Description
Cumulative dose of other anthracyclines
Data type
integer
Measurement units
- mg
Alias
- UMLS CUI [1]
- C2986497
Description
Doxorubicin treatment in 1st sampling period
Description
Haematological toxicity of actual protocol block
Description
Leucocytes
Data type
integer
Measurement units
- 10^3/μL
Alias
- UMLS CUI [1,1]
- C0023508
- UMLS CUI [1,2]
- C1708760
Description
Platelets
Data type
integer
Measurement units
- 10^3/μL
Alias
- UMLS CUI [1]
- C0005821
Description
Haemoglobin
Data type
integer
Measurement units
- g/dL
Alias
- UMLS CUI [1]
- C0518015
Description
Transfusions
Description
Determination of cardiac function (end of sampling period)
Description
Date
Data type
date
Alias
- UMLS CUI [1]
- C0011008
Description
Blood pressure
Data type
integer
Measurement units
- mm Hg
Alias
- UMLS CUI [1]
- C0005823
Description
Electrocardiography (optional) within 28 days after doxorubicin administration
Data type
integer
Alias
- UMLS CUI [1]
- C1623258
Description
Echocardiography
Data type
integer
Alias
- UMLS CUI [1]
- C0013516
Description
Adverse events
Description
Haemoglobin
Data type
integer
Measurement units
- g/dL
Alias
- UMLS CUI [1]
- C0518015
Description
Leucocytes (total WBC)
Data type
integer
Measurement units
- /mm3
Alias
- UMLS CUI [1]
- C0023516
Description
Neutrophils / granulocytes
Data type
integer
Alias
- UMLS CUI [1]
- C1560233
Description
Platelets
Data type
integer
Alias
- UMLS CUI [1]
- C1963076
Description
Cardiac arrhythmia
Data type
integer
Alias
- UMLS CUI [1]
- C0003811
Description
Left ventricular systolic dysfunction
Data type
integer
Alias
- UMLS CUI [1]
- C1277187
Description
Left ventricular diastolic dysfunction
Data type
integer
Alias
- UMLS CUI [1]
- C1273070
Description
Prolonged QT c interval
Data type
integer
Alias
- UMLS CUI [1]
- C0151878
Description
Pericarditis
Data type
integer
Alias
- UMLS CUI [1]
- C0031046
Description
Myocarditis
Data type
integer
Alias
- UMLS CUI [1]
- C0027059
Description
Hypertension
Data type
integer
Alias
- UMLS CUI [1]
- C0020538
Description
Hypotension
Data type
integer
Alias
- UMLS CUI [1]
- C0020649
Description
Infections
Data type
integer
Alias
- UMLS CUI [1]
- C0009450
Description
Constitutional Symptoms
Data type
integer
Alias
- UMLS CUI [1]
- C0009812
Description
Mucositis / Stomatitis (functional / symptomatic)
Data type
integer
Alias
- UMLS CUI [1]
- C0333355
Description
Vomiting (no. of episodes in 24 h)
Data type
integer
Alias
- UMLS CUI [1]
- C0042963
Description
Diarrhoea
Data type
integer
Alias
- UMLS CUI [1]
- C0232708
Description
Glomerular filtration rate (GFR)
Data type
integer
Alias
- UMLS CUI [1]
- C0017654
Description
Proteinuria
Data type
integer
Alias
- UMLS CUI [1]
- C0033687
Description
Bilirubin
Data type
integer
Alias
- UMLS CUI [1]
- C1278039
Description
AST, SGOT
Data type
integer
Alias
- UMLS CUI [1]
- C0201899
Description
ALT, SGPT
Data type
integer
Alias
- UMLS CUI [1]
- C0376147
Description
Other adverse events Please specify:
Data type
text
Description
Start of next protocol block
Description
Footer module
Similar models
1st Sampling period
- StudyEvent: ODM
C2986497 (UMLS CUI [2])