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

  1. 11/2/15 11/2/15 -
  2. 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

Physical Examination
Description

Physical Examination

Physical Examination Date
Description

Physical Examination Date

Data type

date

Alias
UMLS CUI [1]
C2826643
Height
Description

Height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Description

Weight

Data type

integer

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
BSA
Description

BSA

Data type

text

Measurement units
  • m2
Alias
UMLS CUI [1]
C0005902
m2
Karnofsky Index
Description

Karnofsky Index

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1]
C0206065
%
Determination of cardiac function (before sampling period)
Description

Determination of cardiac function (before sampling period)

Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Blood pressure
Description

Blood pressure

Data type

integer

Measurement units
  • mm Hg
Alias
UMLS CUI [1]
C0005823
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • /min
/min
Echocardiography
Description

Echocardiography

Data type

integer

Alias
UMLS CUI [1]
C0013516
Electrocardiography (optional)
Description

Electrocardiography (optional)

Data type

integer

Alias
UMLS CUI [1]
C1623258
Clinical chemistry
Description

Clinical chemistry

Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Bilirubin (total)
Description

Bilirubin (total)

Data type

integer

Measurement units
  • mg/dL
Alias
UMLS CUI [1]
C0201913
mg/dL
Serum creatinine
Description

Serum creatinine

Data type

integer

Measurement units
  • mg/dL
Alias
UMLS CUI [1]
C0201976
mg/dL
Serum albumin
Description

Serum albumin

Data type

integer

Measurement units
  • mg/dL
mg/dL
GOT / AST
Description

GOT / AST

Data type

integer

Measurement units
  • U/L
Alias
UMLS CUI [1]
C0004002
U/L
GPT / ALT
Description

GPT / ALT

Data type

integer

Measurement units
  • U/L
Alias
UMLS CUI [1]
C0001899
U/L
GFR
Description

GFR

Data type

integer

Measurement units
  • mL/min
Alias
UMLS CUI [1]
C0017654
Haematology
Description

Haematology

Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Haemoglobin
Description

Haemoglobin

Data type

integer

Measurement units
  • g/dL
Alias
UMLS CUI [1]
C0518015
g/dL
Haematocrit
Description

Haematocrit

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1]
C0366777
%
Neutrophils
Description

Neutrophils

Data type

integer

Measurement units
  • /μL
Alias
UMLS CUI [1]
C0027950
/μL
Leucocytes
Description

Leucocytes

Data type

integer

Measurement units
  • /μL
Alias
UMLS CUI [1]
C0023508
/μL
Platelets
Description

Platelets

Data type

integer

Measurement units
  • /μL
Alias
UMLS CUI [1]
C0005821
/μL
Agents that are known to interact with doxorubicin according to SmPCs administered?
Description

Agents that are known to interact with doxorubicin according to SmPCs administered?

Carbamazepine
Description

Carbamazepine

Data type

boolean

Alias
UMLS CUI [1]
C0006949
Cimetidine
Description

Cimetidine

Data type

boolean

Alias
UMLS CUI [1]
C0008783
Cyclosporine
Description

Cyclosporin

Data type

boolean

Alias
UMLS CUI [1]
C0010592
Phenobarbital
Description

Phenobarbital

Data type

boolean

Alias
UMLS CUI [1]
C0031412
Phenytoin
Description

Phenytoin

Data type

boolean

Alias
UMLS CUI [1]
C0031507
Progesterone
Description

Progesterone

Data type

boolean

Alias
UMLS CUI [1]
C0033308
Rifampicin
Description

Rifampicin

Data type

integer

Alias
UMLS CUI [1]
C0035608
Ritonavir
Description

Ritonavir

Data type

boolean

Alias
UMLS CUI [1]
C0292818
Sulfamethoxazole
Description

Sulfamethoxazole

Data type

boolean

Alias
UMLS CUI [1]
C0038689
Verapamil
Description

Verapamil

Data type

boolean

Alias
UMLS CUI [1]
C0042523
Antiemetic agents administered?
Description

Antiemetic agents administered?

Granisetron
Description

Granisetron

Data type

boolean

Alias
UMLS CUI [1]
C0061863
Metoclopramid
Description

Metoclopramid

Data type

boolean

Alias
UMLS CUI [1]
C0025853
Ondansetron
Description

Ondansetron

Data type

boolean

Alias
UMLS CUI [1]
C0061851
Other 5-HT3-receptor antagonists
Description

Other 5-HT3-receptor antagonists

Data type

boolean

Alias
UMLS CUI [1]
C0360055
Aprepitant
Description

Aprepitant

Data type

boolean

Alias
UMLS CUI [1]
C1176306
Alizapride
Description

Alizapride

Data type

boolean

Alias
UMLS CUI [1]
C0051162
Dexamethason administered?
Description

Dexamethason administered?

Data type

boolean

Alias
UMLS CUI [1]
C0011777
Dimenhydrinate administered?
Description

Dimenhydrinate administered?

Data type

boolean

Alias
UMLS CUI [1]
C0012381
Domperidone administered?
Description

Domperidone administered?

Data type

boolean

Alias
UMLS CUI [1]
C0013015
Lorazepam administered?
Description

Lorazepam administered?

Data type

boolean

Alias
UMLS CUI [1]
C0024002
Other
Description

Other

Data type

boolean

Alias
UMLS CUI [1]
C0003297
Cardioprotective agents administered?
Description

Cardioprotective agents administered?

Dexrazoxane
Description

Dexrazoxane

Data type

boolean

Alias
UMLS CUI [1]
C0086444
Other(s)
Description

Other(s)

Data type

integer

Alias
UMLS CUI [1]
C0205394
Systemic antimycotic agents
Description

Systemic antimycotic agents

Azole antimycotics
Description

Azole antimycotics

Data type

boolean

Alias
UMLS CUI [1]
C0004504
Other(s)
Description

Other(s)

Data type

integer

Alias
UMLS CUI [1]
C0205394
Other agents administered?
Description

Other agents administered?

Antibiotic agents
Description

Antibiotic agents

Data type

boolean

Alias
UMLS CUI [1]
C0003232
Anticonvulsive agents
Description

Anticonvulsive agents

Data type

boolean

Alias
UMLS CUI [1]
C0003286
Cardioactive agents
Description

Cardioactive agents

Data type

boolean

Proton pump inhibitors
Description

Proton pump inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0358591
Contraceptive agents
Description

Contraceptive agents

Data type

boolean

Alias
UMLS CUI [1]
C0009871
Systemic antiviral agents
Description

Systemic antiviral agents

Data type

boolean

Alias
UMLS CUI [1]
C0854610
Actual protocol block
Description

Actual protocol block

Wilms tumour
Description

Wilms tumour

Data type

integer

Alias
UMLS CUI [1]
C0027708
Neuroblastoma
Description

Neuroblastoma

Data type

integer

Alias
UMLS CUI [1]
C0027819
Ewing sarcoma
Description

Ewing sarcoma

Data type

integer

Alias
UMLS CUI [1]
C0553580
Soft tissue sarcoma
Description

Soft tissue sarcoma

Data type

integer

Alias
UMLS CUI [1]
C0153561
ALL
Description

ALL

Data type

integer

Other:
Description

Other:

Data type

integer

Alias
UMLS CUI [1]
C0027651
Start of actual protocol block
Description

Start of actual protocol block

Without delay
Description

Without delay

Data type

integer

Alias
UMLS CUI [1]
C0205421
With delay of
Description

With delay of

Data type

integer

Alias
UMLS CUI [1]
C0205421
Chemotherapy in actual protocol block administered ?
Description

Chemotherapy in actual protocol block administered ?

Actinomycine D
Description

Actinomycine D

Data type

integer

Alias
UMLS CUI [1]
C0010934
Asparaginase
Description

Asparaginase

Data type

integer

Alias
UMLS CUI [1]
C0003993
Cyclophosphamide
Description

Cyclophosphamide

Data type

integer

Alias
UMLS CUI [1]
C0010583
Dacarbazine
Description

Dacarbazine

Data type

integer

Alias
UMLS CUI [1]
C0010927
Dexamethasone
Description

Dexamethasone

Data type

integer

Alias
UMLS CUI [1]
C0011777
Etoposide
Description

Etoposide

Data type

integer

Alias
UMLS CUI [1]
C0015133
Ifosfamide
Description

Ifosfamide

Data type

integer

Alias
UMLS CUI [1]
C0020823
Topotecan
Description

Topotecan

Data type

integer

Alias
UMLS CUI [1]
C0146224
Vincristine
Description

Vincristine

Data type

integer

Alias
UMLS CUI [1]
C0042679
Other: (INN name)
Description

Other: (INN name)

Data type

integer

Alias
UMLS CUI [1]
C0729502
Previous anthracycline treatment
Description

Previous anthracycline treatment

Cumulative doxorubicin dose
Description

Cumulative doxorubicin dose

Data type

integer

Measurement units
  • mg
Alias
UMLS CUI [1]
C0013089
UMLS CUI [2]
C2986497
mg
Other anthracyclines administered
Description

Other anthracyclines administered

Data type

integer

Alias
UMLS CUI [1]
C0282564
Cumulative dose of other anthracyclines
Description

Cumulative dose of other anthracyclines

Data type

integer

Measurement units
  • mg
Alias
UMLS CUI [1]
C2986497
mg
Doxorubicin treatment in 1st sampling period
Description

Doxorubicin treatment in 1st sampling period

Brand name
Description

Brand name

Data type

integer

Alias
UMLS CUI [1]
C0013089
UMLS CUI [2]
C0592503
Haematological toxicity of actual protocol block
Description

Haematological toxicity of actual protocol block

Leucocytes
Description

Leucocytes

Data type

integer

Measurement units
  • 10^3/μL
Alias
UMLS CUI [1,1]
C0023508
UMLS CUI [1,2]
C1708760
Platelets
Description

Platelets

Data type

integer

Measurement units
  • 10^3/μL
Alias
UMLS CUI [1]
C0005821
Haemoglobin
Description

Haemoglobin

Data type

integer

Measurement units
  • g/dL
Alias
UMLS CUI [1]
C0518015
Transfusions
Description

Transfusions

Number of days with platelets transfusions
Description

Number of days with platelets transfusions

Data type

integer

Alias
UMLS CUI [1]
C0086818
Number of days with erythrocytes transfusions
Description

Number of days with erythrocytes transfusions

Data type

integer

Alias
UMLS CUI [1]
C0086252
Determination of cardiac function (end of sampling period)
Description

Determination of cardiac function (end of sampling period)

Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Blood pressure
Description

Blood pressure

Data type

integer

Measurement units
  • mm Hg
Alias
UMLS CUI [1]
C0005823
Electrocardiography (optional) within 28 days after doxorubicin administration
Description

Electrocardiography (optional) within 28 days after doxorubicin administration

Data type

integer

Alias
UMLS CUI [1]
C1623258
Echocardiography
Description

Echocardiography

Data type

integer

Alias
UMLS CUI [1]
C0013516
Adverse events
Description

Adverse events

Haemoglobin
Description

Haemoglobin

Data type

integer

Measurement units
  • g/dL
Alias
UMLS CUI [1]
C0518015
Leucocytes (total WBC)
Description

Leucocytes (total WBC)

Data type

integer

Measurement units
  • /mm3
Alias
UMLS CUI [1]
C0023516
Neutrophils / granulocytes
Description

Neutrophils / granulocytes

Data type

integer

Alias
UMLS CUI [1]
C1560233
Platelets
Description

Platelets

Data type

integer

Alias
UMLS CUI [1]
C1963076
Cardiac arrhythmia
Description

Cardiac arrhythmia

Data type

integer

Alias
UMLS CUI [1]
C0003811
Left ventricular systolic dysfunction
Description

Left ventricular systolic dysfunction

Data type

integer

Alias
UMLS CUI [1]
C1277187
Left ventricular diastolic dysfunction
Description

Left ventricular diastolic dysfunction

Data type

integer

Alias
UMLS CUI [1]
C1273070
Prolonged QT c interval
Description

Prolonged QT c interval

Data type

integer

Alias
UMLS CUI [1]
C0151878
Pericarditis
Description

Pericarditis

Data type

integer

Alias
UMLS CUI [1]
C0031046
Myocarditis
Description

Myocarditis

Data type

integer

Alias
UMLS CUI [1]
C0027059
Hypertension
Description

Hypertension

Data type

integer

Alias
UMLS CUI [1]
C0020538
Hypotension
Description

Hypotension

Data type

integer

Alias
UMLS CUI [1]
C0020649
Infections
Description

Infections

Data type

integer

Alias
UMLS CUI [1]
C0009450
Constitutional Symptoms
Description

Constitutional Symptoms

Data type

integer

Alias
UMLS CUI [1]
C0009812
Mucositis / Stomatitis (functional / symptomatic)
Description

Mucositis / Stomatitis (functional / symptomatic)

Data type

integer

Alias
UMLS CUI [1]
C0333355
Vomiting (no. of episodes in 24 h)
Description

Vomiting (no. of episodes in 24 h)

Data type

integer

Alias
UMLS CUI [1]
C0042963
Diarrhoea
Description

Diarrhoea

Data type

integer

Alias
UMLS CUI [1]
C0232708
Glomerular filtration rate (GFR)
Description

Glomerular filtration rate (GFR)

Data type

integer

Alias
UMLS CUI [1]
C0017654
Proteinuria
Description

Proteinuria

Data type

integer

Alias
UMLS CUI [1]
C0033687
Bilirubin
Description

Bilirubin

Data type

integer

Alias
UMLS CUI [1]
C1278039
AST, SGOT
Description

AST, SGOT

Data type

integer

Alias
UMLS CUI [1]
C0201899
ALT, SGPT
Description

ALT, SGPT

Data type

integer

Alias
UMLS CUI [1]
C0376147
Other adverse events Please specify:
Description

Other adverse events Please specify:

Data type

text

Start of next protocol block
Description

Start of next protocol block

Without delay
Description

Without delay

Data type

text

With delay of days
Description

With delay of days

Data type

text

Alias
UMLS CUI [1]
C1689929
Footer module
Description

Footer module

Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Name Investigator
Description

Name Investigator

Data type

text

Alias
UMLS CUI [1]
C2826892
Signature Investigator
Description

Signature Investigator

Data type

text

Alias
UMLS CUI [1]
C2346576

Similar models

1st Sampling period

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Physical Examination
Physical Examination Date
Item
Physical Examination Date
date
C2826643 (UMLS CUI [1])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
integer
C0005910 (UMLS CUI [1])
BSA
Item
BSA
text
C0005902 (UMLS CUI [1])
Karnofsky Index
Item
Karnofsky Index
integer
C0206065 (UMLS CUI [1])
Item Group
Determination of cardiac function (before sampling period)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Item
Blood pressure
integer
C0005823 (UMLS CUI [1])
Code List
Blood pressure
CL Item
sys  (1)
C0871470 (UMLS CUI-1)
CL Item
dia (2)
C0428883 (UMLS CUI-1)
Heart rate
Item
Heart rate
integer
Item
Echocardiography
integer
C0013516 (UMLS CUI [1])
Code List
Echocardiography
CL Item
LVEDD (1)
C0488787 (UMLS CUI-1)
CL Item
IVS (2)
C2215786 (UMLS CUI-1)
CL Item
LVSF (3)
C0745679 (UMLS CUI-1)
CL Item
LVESD (4)
C1142544 (UMLS CUI-1)
CL Item
LVPW (5)
C0203366 (UMLS CUI-1)
CL Item
LVEF (6)
C0428772 (UMLS CUI-1)
Item
Electrocardiography (optional)
integer
C1623258 (UMLS CUI [1])
Code List
Electrocardiography (optional)
CL Item
Not done (1)
C1272696 (UMLS CUI-1)
CL Item
Date: (2)
C0011008 (UMLS CUI-1)
CL Item
ECG findings (3)
C0438154 (UMLS CUI-1)
CL Item
If abnormal, please specify (4)
C0205161 (UMLS CUI-1)
Item Group
Clinical chemistry
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Bilirubin (total)
Item
Bilirubin (total)
integer
C0201913 (UMLS CUI [1])
Serum creatinine
Item
Serum creatinine
integer
C0201976 (UMLS CUI [1])
Serum albumin
Item
Serum albumin
integer
GOT / AST
Item
GOT / AST
integer
C0004002 (UMLS CUI [1])
GPT / ALT
Item
GPT / ALT
integer
C0001899 (UMLS CUI [1])
Item
GFR
integer
C0017654 (UMLS CUI [1])
Code List
GFR
CL Item
GFR estimated: (1)
C2170215 (UMLS CUI-1)
CL Item
By radioactivity measurement (2)
C0597748 (UMLS CUI-1)
CL Item
By urine collection (3)
C2371162 (UMLS CUI-1)
CL Item
From a single measurement of serum-creatinine (4)
C0201976 (UMLS CUI-1)
Item Group
Haematology
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Haemoglobin
Item
Haemoglobin
integer
C0518015 (UMLS CUI [1])
Haematocrit
Item
Haematocrit
integer
C0366777 (UMLS CUI [1])
Neutrophils
Item
Neutrophils
integer
C0027950 (UMLS CUI [1])
Leucocytes
Item
Leucocytes
integer
C0023508 (UMLS CUI [1])
Platelets
Item
Platelets
integer
C0005821 (UMLS CUI [1])
Item Group
Agents that are known to interact with doxorubicin according to SmPCs administered?
Carbamazepine
Item
Carbamazepine
boolean
C0006949 (UMLS CUI [1])
Cimetidine
Item
Cimetidine
boolean
C0008783 (UMLS CUI [1])
Cyclosporin
Item
Cyclosporine
boolean
C0010592 (UMLS CUI [1])
Phenobarbital
Item
Phenobarbital
boolean
C0031412 (UMLS CUI [1])
Phenytoin
Item
Phenytoin
boolean
C0031507 (UMLS CUI [1])
Progesterone
Item
Progesterone
boolean
C0033308 (UMLS CUI [1])
Rifampicin
Item
Rifampicin
integer
C0035608 (UMLS CUI [1])
Ritonavir
Item
Ritonavir
boolean
C0292818 (UMLS CUI [1])
Sulfamethoxazole
Item
Sulfamethoxazole
boolean
C0038689 (UMLS CUI [1])
Verapamil
Item
Verapamil
boolean
C0042523 (UMLS CUI [1])
Item Group
Antiemetic agents administered?
Granisetron
Item
Granisetron
boolean
C0061863 (UMLS CUI [1])
Metoclopramid
Item
Metoclopramid
boolean
C0025853 (UMLS CUI [1])
Ondansetron
Item
Ondansetron
boolean
C0061851 (UMLS CUI [1])
Other 5-HT3-receptor antagonists
Item
Other 5-HT3-receptor antagonists
boolean
C0360055 (UMLS CUI [1])
Aprepitant
Item
Aprepitant
boolean
C1176306 (UMLS CUI [1])
Alizapride
Item
Alizapride
boolean
C0051162 (UMLS CUI [1])
Dexamethason administered?
Item
Dexamethason administered?
boolean
C0011777 (UMLS CUI [1])
Dimenhydrinate administered?
Item
Dimenhydrinate administered?
boolean
C0012381 (UMLS CUI [1])
Domperidone administered?
Item
Domperidone administered?
boolean
C0013015 (UMLS CUI [1])
Lorazepam administered?
Item
Lorazepam administered?
boolean
C0024002 (UMLS CUI [1])
Other
Item
Other
boolean
C0003297 (UMLS CUI [1])
Item Group
Cardioprotective agents administered?
Dexrazoxane
Item
Dexrazoxane
boolean
C0086444 (UMLS CUI [1])
Item
Other(s)
integer
C0205394 (UMLS CUI [1])
Code List
Other(s)
CL Item
If other(s): (INN name) (1)
Item Group
Systemic antimycotic agents
Azole antimycotics
Item
Azole antimycotics
boolean
C0004504 (UMLS CUI [1])
Item
Other(s)
integer
C0205394 (UMLS CUI [1])
Code List
Other(s)
CL Item
If other(s): (INN name) (1)
Item Group
Other agents administered?
Antibiotic agents
Item
Antibiotic agents
boolean
C0003232 (UMLS CUI [1])
Anticonvulsive agents
Item
Anticonvulsive agents
boolean
C0003286 (UMLS CUI [1])
Cardioactive agents
Item
Cardioactive agents
boolean
Proton pump inhibitors
Item
Proton pump inhibitors
boolean
C0358591 (UMLS CUI [1])
Contraceptive agents
Item
Contraceptive agents
boolean
C0009871 (UMLS CUI [1])
Systemic antiviral agents
Item
Systemic antiviral agents
boolean
C0854610 (UMLS CUI [1])
Item Group
Actual protocol block
Item
Wilms tumour
integer
C0027708 (UMLS CUI [1])
Code List
Wilms tumour
CL Item
AVD (1)
CL Item
High Risk (2)
Item
Neuroblastoma
integer
C0027819 (UMLS CUI [1])
Code List
Neuroblastoma
CL Item
N4 (1)
CL Item
N6 (2)
CL Item
TVD (3)
CL Item
CADO (4)
Item
Ewing sarcoma
integer
C0553580 (UMLS CUI [1])
Code List
Ewing sarcoma
CL Item
VIDE (1)
CL Item
VAC (2)
CL Item
VAI (3)
Item
Soft tissue sarcoma
integer
C0153561 (UMLS CUI [1])
Code List
Soft tissue sarcoma
CL Item
VAIA III (1)
CL Item
High risk (2)
CL Item
IA (3)
Item
ALL
integer
Code List
ALL
CL Item
Protocol II (1)
CL Item
Consolidation (2)
CL Item
Intensification (3)
CL Item
Delayed Intensification (4)
Other:
Item
Other:
integer
C0027651 (UMLS CUI [1])
Item Group
Start of actual protocol block
Without delay
Item
Without delay
integer
C0205421 (UMLS CUI [1])
Item
With delay of
integer
C0205421 (UMLS CUI [1])
Code List
With delay of
CL Item
Due to toxicity of previous protocol block (1)
CL Item
Due to other reasons (2)
Item Group
Chemotherapy in actual protocol block administered ?
Item
Actinomycine D
integer
C0010934 (UMLS CUI [1])
Code List
Actinomycine D
CL Item
No (1)
C1298908 (UMLS CUI-1)
CL Item
Yes, per protocol (2)
C0392920 (UMLS CUI-1)
CL Item
Yes, but not per protocol (3)
C0392920 (UMLS CUI-1)
Item
Asparaginase
integer
C0003993 (UMLS CUI [1])
Code List
Asparaginase
CL Item
No (1)
CL Item
Yes, per protocol (2)
CL Item
Yes, but not per protocol (3)
Item
Cyclophosphamide
integer
C0010583 (UMLS CUI [1])
Code List
Cyclophosphamide
CL Item
No (1)
CL Item
Yes, per protocol (2)
CL Item
Yes, but not per protocol (3)
Item
Dacarbazine
integer
C0010927 (UMLS CUI [1])
Code List
Dacarbazine
CL Item
No (1)
CL Item
Yes, per protocol (2)
CL Item
Yes, but not per protocol (3)
Item
Dexamethasone
integer
C0011777 (UMLS CUI [1])
Code List
Dexamethasone
CL Item
No (1)
CL Item
Yes, per protocol (2)
CL Item
Yes, but not per protocol (3)
Item
Etoposide
integer
C0015133 (UMLS CUI [1])
Code List
Etoposide
CL Item
No (1)
CL Item
Yes, per protocol (2)
CL Item
Yes, but not per protocol (3)
Item
Ifosfamide
integer
C0020823 (UMLS CUI [1])
Code List
Ifosfamide
CL Item
No (1)
CL Item
Yes, per protocol (2)
CL Item
Yes, but not per protocol (3)
Item
Topotecan
integer
C0146224 (UMLS CUI [1])
Code List
Topotecan
CL Item
No (1)
CL Item
Yes, per protocol (2)
CL Item
Yes, but not per protocol (3)
Item
Vincristine
integer
C0042679 (UMLS CUI [1])
Code List
Vincristine
CL Item
No (1)
CL Item
Yes, per protocol (2)
CL Item
Yes, but not per protocol (3)
Item
Other: (INN name)
integer
C0729502 (UMLS CUI [1])
Code List
Other: (INN name)
CL Item
No (1)
CL Item
Yes, per protocol (2)
CL Item
Yes, but not per protocol (3)
Item Group
Previous anthracycline treatment
Cumulative doxorubicin dose
Item
Cumulative doxorubicin dose
integer
C0013089 (UMLS CUI [1])
C2986497 (UMLS CUI [2])
Item
Other anthracyclines administered
integer
C0282564 (UMLS CUI [1])
Code List
Other anthracyclines administered
CL Item
Daunorubicin (1)
C0011015 (UMLS CUI-1)
CL Item
Epirubicin (2)
C0014582 (UMLS CUI-1)
CL Item
Idarubicin (3)
C0020789 (UMLS CUI-1)
CL Item
Mitoxantrone (4)
C0026259 (UMLS CUI-1)
Cumulative dose of other anthracyclines
Item
Cumulative dose of other anthracyclines
integer
C2986497 (UMLS CUI [1])
Item Group
Doxorubicin treatment in 1st sampling period
Item
Brand name
integer
C0013089 (UMLS CUI [1])
C0592503 (UMLS CUI [2])
Code List
Brand name
CL Item
Adriblastin(e)/Adriblastina®(Pfizer/Pharmacia) (1)
C2936928 (UMLS CUI-1)
CL Item
Doxorubicin (Hydrochloride) (TEVA) (2)
C0013089 (UMLS CUI-1)
CL Item
Adrimedac® (Medac)  (3)
C1512055 (UMLS CUI-1)
CL Item
Ribodoxo® (Hikma) (4)
C1564915 (UMLS CUI-1)
CL Item
DOXO-Cell® (Cell Pharm)  (5)
C1512056 (UMLS CUI-1)
CL Item
Other (6)
C0205394 (UMLS CUI-1)
Item Group
Haematological toxicity of actual protocol block
Item
Leucocytes
integer
C0023508 (UMLS CUI [1,1])
C1708760 (UMLS CUI [1,2])
Code List
Leucocytes
CL Item
Nadir (1)
C1708760 (UMLS CUI-1)
CL Item
Date of nadir (2)
C0011008 (UMLS CUI-1)
CL Item
Date of recovery (3)
C0237820 (UMLS CUI-1)
Item
Platelets
integer
C0005821 (UMLS CUI [1])
Code List
Platelets
CL Item
Nadir  (1)
CL Item
Date of nadir  (2)
CL Item
Date of recovery (3)
Item
Haemoglobin
integer
C0518015 (UMLS CUI [1])
Code List
Haemoglobin
CL Item
Nadir  (1)
CL Item
Date of nadir  (2)
CL Item
Date of recovery (3)
Item Group
Transfusions
Number of days with platelets transfusions
Item
Number of days with platelets transfusions
integer
C0086818 (UMLS CUI [1])
Number of days with erythrocytes transfusions
Item
Number of days with erythrocytes transfusions
integer
C0086252 (UMLS CUI [1])
Item Group
Determination of cardiac function (end of sampling period)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Item
Blood pressure
integer
C0005823 (UMLS CUI [1])
Code List
Blood pressure
CL Item
sys  (1)
C0871470 (UMLS CUI-1)
CL Item
dia (2)
C0428883 (UMLS CUI-1)
Item
Electrocardiography (optional) within 28 days after doxorubicin administration
integer
C1623258 (UMLS CUI [1])
Code List
Electrocardiography (optional) within 28 days after doxorubicin administration
CL Item
Not done: (1)
C1272696 (UMLS CUI-1)
CL Item
Date: (2)
C0011008 (UMLS CUI-1)
CL Item
Routine practice (3)
C0205547 (UMLS CUI-1)
CL Item
Adverse Event (4)
C0877248 (UMLS CUI-1)
CL Item
Control of preknown condition (5)
C0348080 (UMLS CUI-1)
CL Item
Other (6)
C0205394 (UMLS CUI-1)
CL Item
ECG findings (7)
C0438154 (UMLS CUI-1)
CL Item
If abnormal, please specify (8)
C0205161 (UMLS CUI-1)
Item
Echocardiography
integer
C0013516 (UMLS CUI [1])
Code List
Echocardiography
CL Item
LVEDD (1)
C0488787 (UMLS CUI-1)
CL Item
IVS (2)
C2215786 (UMLS CUI-1)
CL Item
LVSF (3)
C0745679 (UMLS CUI-1)
CL Item
LVESD (4)
C1142544 (UMLS CUI-1)
CL Item
LVPW (5)
C0203366 (UMLS CUI-1)
CL Item
LVEF (6)
C0428772 (UMLS CUI-1)
Item Group
Adverse events
Item
Haemoglobin
integer
C0518015 (UMLS CUI [1])
Code List
Haemoglobin
CL Item
Grade 0 - 2 (1)
CL Item
Grade 3  (2)
CL Item
Grade 4  (3)
CL Item
Grade 5 (SAE-Report) (4)
Item
Leucocytes (total WBC)
integer
C0023516 (UMLS CUI [1])
Code List
Leucocytes (total WBC)
CL Item
Grade 0 - 2 (1)
CL Item
Grade 3  (2)
CL Item
Grade 4  (3)
CL Item
Grade 5 (SAE-Report) (4)
Item
Neutrophils / granulocytes
integer
C1560233 (UMLS CUI [1])
Code List
Neutrophils / granulocytes
CL Item
Grade 0 - 2 (1)
CL Item
Grade 3  (2)
CL Item
Grade 4  (3)
CL Item
Grade 5 (SAE-Report) (4)
Item
Platelets
integer
C1963076 (UMLS CUI [1])
Code List
Platelets
CL Item
Grade 0 - 2 (1)
CL Item
Grade 3  (2)
CL Item
Grade 4  (3)
CL Item
Grade 5 (SAE-Report) (4)
Item
Cardiac arrhythmia
integer
C0003811 (UMLS CUI [1])
Code List
Cardiac arrhythmia
CL Item
Symptomatic and incompletely controlled medically or controlled with device (e.g. defibrillator) (1)
C0025080 (UMLS CUI-1)
CL Item
Life-threatening (e.g. arrhythmia associated with CHF, hypotension, syncope, shock) (2)
C1517874 (UMLS CUI-1)
Item
Left ventricular systolic dysfunction
integer
C1277187 (UMLS CUI [1])
Code List
Left ventricular systolic dysfunction
CL Item
Symptomatic CHF responsive to intervention; EF < 40-20% SF < 15% (1)
C0018802 (UMLS CUI-1)
CL Item
Refractory CHF or poorly controlled; EF < 20%; intervention such as ventricular assist device, ventricular reduction surgery, or heart transplant indicated (2)
C0018802 (UMLS CUI-1)
Item
Left ventricular diastolic dysfunction
integer
C1273070 (UMLS CUI [1])
Code List
Left ventricular diastolic dysfunction
CL Item
Symptomatic CHF responsive to intervention (1)
C0018802 (UMLS CUI-1)
CL Item
Refractory CHF, poorly controlled; intervention such as ventricular assist device or heart transplant indicated (2)
C0018802 (UMLS CUI-1)
Item
Prolonged QT c interval
integer
C0151878 (UMLS CUI [1])
Code List
Prolonged QT c interval
CL Item
QT c > 0.50 second (1)
C0860814 (UMLS CUI-1)
CL Item
QT c > 0.5 second; life-threatening signs or symptoms (e.g. arrhythmia, CHF, hypotension, shock syncope); Torsade de pointes (2)
C0860814 (UMLS CUI-1)
Item
Pericarditis
integer
C0031046 (UMLS CUI [1])
Code List
Pericarditis
CL Item
Pericarditis with physiologic consequences (e.g. pericardial constriction) (1)
C0031046 (UMLS CUI-1)
CL Item
Life-threatening consequences; emergency intervention indicated (2)
C1546953 (UMLS CUI-1)
Item
Myocarditis
integer
C0027059 (UMLS CUI [1])
Code List
Myocarditis
CL Item
CHF responsive to intervention (1)
C0018802 (UMLS CUI-1)
CL Item
Severe or refractory CHF (2)
C0018802 (UMLS CUI-1)
Item
Hypertension
integer
C0020538 (UMLS CUI [1])
Code List
Hypertension
CL Item
Requiring more than one drug or more intensive therapy than previously (1)
C0419205 (UMLS CUI-1)
CL Item
Life-threatening (e.g. hypertensive crisis) (2)
C1517874 (UMLS CUI-1)
Item
Hypotension
integer
C0020649 (UMLS CUI [1])
Code List
Hypotension
CL Item
Sustained (≥ 24 h) therapy, resolves without persisting physiologic consequences (1)
C2038514 (UMLS CUI-1)
CL Item
Shock (e.g. acidaemia; impairment of vital organ function) (2)
C0036974 (UMLS CUI-1)
Item
Infections
integer
C0009450 (UMLS CUI [1])
Code List
Infections
CL Item
Specify: (1)
Item
Constitutional Symptoms
integer
C0009812 (UMLS CUI [1])
Code List
Constitutional Symptoms
CL Item
> 40.0°C (> 104.0°F) for ≤ 24 hrs (1)
C0424755 (UMLS CUI-1)
CL Item
> 40.0°C (> 104.0°F) for > 24 hrs (2)
C0424755 (UMLS CUI-1)
Item
Mucositis / Stomatitis (functional / symptomatic)
integer
C0333355 (UMLS CUI [1])
Code List
Mucositis / Stomatitis (functional / symptomatic)
CL Item
Upper aerodigestive tract sites: Symptomatic and unable to adequately aliment or hydrate orally; respiratory symptoms interfering with ADL Lower GI sites: Stool incontinence or other symptoms interfering with ADL (1)
C1267213 (UMLS CUI-1)
CL Item
Symptoms associated with life-threatening consequences (2)
C1546953 (UMLS CUI-1)
Item
Vomiting (no. of episodes in 24 h)
integer
C0042963 (UMLS CUI [1])
Code List
Vomiting (no. of episodes in 24 h)
CL Item
≥ 6 episodes in 24 hrs; IV fluids, or TPN indicated ≥ 24 hrs (1)
C0030548 (UMLS CUI-1)
CL Item
Life-threatening consequences (2)
C2826244 (UMLS CUI-1)
Item
Diarrhoea
integer
C0232708 (UMLS CUI [1])
Code List
Diarrhoea
CL Item
Increase of ≥ 7 stools per day over baseline; incontinence; IV fluids ≥ 24 hrs; hospitalization; severe increase in ostomy output compared to baseline; interfering with ADL (1)
C0162287 (UMLS CUI-1)
CL Item
Life-threatening consequences (e.g. haemodynamic collapse) (2)
C1517874 (UMLS CUI-1)
Item
Glomerular filtration rate (GFR)
integer
C0017654 (UMLS CUI [1])
Code List
Glomerular filtration rate (GFR)
CL Item
< 25% LLN, chronic dialysis not indicated (1)
C1518030 (UMLS CUI-1)
CL Item
Chronic dialysis or renal transplant indicated (2)
C0743165 (UMLS CUI-1)
Item
Proteinuria
integer
C0033687 (UMLS CUI [1])
Code List
Proteinuria
CL Item
4+ or > 3.5 g/24 hrs (1)
C1962972 (UMLS CUI-1)
CL Item
Nephrotic syndrome (2)
C0027726 (UMLS CUI-1)
Item
Bilirubin
integer
C1278039 (UMLS CUI [1])
Code List
Bilirubin
CL Item
> 3.0 – 10.0 x ULN  (1)
CL Item
> 10.0 x ULN (2)
Item
AST, SGOT
integer
C0201899 (UMLS CUI [1])
Code List
AST, SGOT
CL Item
> 5.0 – 20.0 x ULN  (1)
CL Item
> 20.0 x ULN (2)
Item
ALT, SGPT
integer
C0376147 (UMLS CUI [1])
Code List
ALT, SGPT
CL Item
> 5.0 – 20.0 x ULN  (1)
CL Item
> 20.0 x ULN (2)
Item
Other adverse events Please specify:
text
Code List
Other adverse events Please specify:
CL Item
Grade 0 - 2 (1)
CL Item
Grade 3  (2)
CL Item
Grade 4  (3)
CL Item
Grade 5 (SAE-Report) (4)
Item Group
Start of next protocol block
Without delay
Item
Without delay
text
Item
With delay of days
text
C1689929 (UMLS CUI [1])
Code List
With delay of days
CL Item
Due to toxicity of previous protocol block (Due to toxicity of previous protocol block)
CL Item
Due to other reasons (Due to other reasons)
Item Group
Footer module
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Name Investigator
Item
Name Investigator
text
C2826892 (UMLS CUI [1])
Signature Investigator
Item
Signature Investigator
text
C2346576 (UMLS CUI [1])

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