ID

41563

Description

A Non-inferiority Study Comparing Two Filgrastim Preparations in Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01079676

Lien

https://clinicaltrials.gov/show/NCT01079676

Mots-clés

Versions (1)
  1. 11/11/2020 11/11/2020 -
Détendeur de droits

see on clinicaltrials.gov

Téléchargé le

11 novembre 2020

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Neutropenia in Breast Cancer NCT01079676

Anglais

Eligibility Neutropenia in Breast Cancer NCT01079676

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed icf;
Description

signed informed consent form

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
diagnosis confirmed by anatomic pathology examination (cytology or histopathology) of breast cancer;
Description

diagnosis confirmed by anatomic pathology examination (cytology or histopathology) of breast cancer

Type de données

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C1265900
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C0449575
clinical or imaging confirmation of stage II to IV disease, according to the tnm classification;
Description

clinical or imaging confirmation of TNM Breast Tumor staging

Type de données

boolean

Alias
UMLS CUI [1,1]
C1456356
UMLS CUI [1,2]
C0474926
UMLS CUI [2,1]
C0011923
UMLS CUI [2,2]
C0474926
indication for chemotherapy with one of the eligible regimens, as long as the treatment in the first cycle is planned as full dose (without adjustments relative to the original regimen)
Description

indication for chemotherapy with one of the eligible regimens except for relative dose adjustments in the first cycle

Type de données

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C1548635
UMLS CUI [1,3]
C0392920
UMLS CUI [2,1]
C0332300
UMLS CUI [2,2]
C2826232
UMLS CUI [2,3]
C0205435
UMLS CUI [2,4]
C1302181
performance status from 0 to 1 on the zubrod scale
Description

performance status on the zubrod scale

Type de données

boolean

Alias
UMLS CUI [1]
C3714786
no more than one previous chemotherapeutic regimen for metastatic disease
Description

no more than one previous chemotherapeutic regimen for metastatic disease

Type de données

boolean

Alias
UMLS CUI [1,1]
C0205156
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0027627
UMLS CUI [1,4]
C0332300
UMLS CUI [1,5]
C0439064
proper organic functions, as indicated by all the following conditions: anc >1500/mm3, platelet count >150000/mm3, serum creatinine <1,2 mg/dl, bilirubins and transaminases (aspartate aminotransferase [ast] and alanine aminotransferase [alt]) <1.5 times the upper limit of normal
Description

proper organic functions, as indicated by: anc >1500/mm3, platelet count >150000/mm3, serum creatinine <1,2 mg/dl, bilirubins and transaminases (aspartate aminotransferase [ast] and alanine aminotransferase [alt]) <1.5 times the upper limit of normal

Type de données

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0201976
UMLS CUI [4]
C0005437
UMLS CUI [5]
C0201899
UMLS CUI [6]
C0201836
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
forecast of prophylactic or therapeutic use of antibiotics, antifungal or antiviral in the first cycle of chemotherapy;
Description

forecast of use of antibiotics, antifungal or antiviral in the first cycle of chemotherapy

Type de données

boolean

Alias
UMLS CUI [1,1]
C0681842
UMLS CUI [1,2]
C0003232
UMLS CUI [1,3]
C0205435
UMLS CUI [1,4]
C1302181
UMLS CUI [2,1]
C0681842
UMLS CUI [2,2]
C0003308
UMLS CUI [2,3]
C0205435
UMLS CUI [2,4]
C1302181
UMLS CUI [3,1]
C0681842
UMLS CUI [3,2]
C2363964
UMLS CUI [3,3]
C0205435
UMLS CUI [3,4]
C1302181
previous radiotherapy involving pelvis or radiotherapy of any site on the last 6 weeks before randomization;
Description

previous radiotherapy involving pelvis or recent radiotherapy of any site

Type de données

boolean

Alias
UMLS CUI [1,1]
C0205156
UMLS CUI [1,2]
C1536155
UMLS CUI [2,1]
C0332185
UMLS CUI [2,2]
C1522449
history of bone marrow transplantation (as receptor)
Description

history of bone marrow transplantation

Type de données

boolean

Alias
UMLS CUI [1]
C0005961
presence of other neoplasias, with the exception of in situ cervical carcinoma, in situ bladder carcinoma, cutaneous basal cell carcinoma properly treated, cutaneous spinocellular carcinoma properly treated, t1 vocal cords cancer under remission or previous malignant neoplasia treated more than 5 years before the recruitment and without relapse;
Description

presence of other neoplasias, with the exception of in situ cervical carcinoma, in situ bladder carcinoma, cutaneous spinocellular carcinoma properly treated, t1 vocal cords cancer under remission or previous malignant neoplasia treated more than 5 years before the recruitment and without relapse;

Type de données

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0027651
UMLS CUI [2,1]
C0332300
UMLS CUI [2,2]
C0851140
UMLS CUI [3,1]
C0332300
UMLS CUI [3,2]
C0007099
UMLS CUI [3,3]
C0005682
UMLS CUI [4,1]
C0332300
UMLS CUI [4,2]
C0007117
UMLS CUI [4,3]
C0087111
UMLS CUI [4,4]
C0205410
UMLS CUI [5,1]
C0332300
UMLS CUI [5,2]
C0553723
UMLS CUI [5,3]
C0087111
UMLS CUI [5,4]
C0205410
UMLS CUI [6,1]
C0332300
UMLS CUI [6,2]
C0042930
UMLS CUI [6,3]
C0006826
UMLS CUI [6,4]
C0475372
UMLS CUI [6,5]
C0544452
UMLS CUI [7,1]
C0332300
UMLS CUI [7,2]
C0006826
UMLS CUI [7,3]
C0205156
UMLS CUI [7,4]
C0087111
UMLS CUI [8,1]
C0332300
UMLS CUI [8,2]
C0006826
UMLS CUI [8,3]
C0332288
UMLS CUI [8,4]
C0035020
presence of severe comorbidities, such as cardiovascular, chronic respiratory, kidney, liver, neurological, hematological, infectious, skin, neurological or psychiatric disease
Description

presence of severe comorbidities, such as cardiovascular, chronic respiratory, kidney, liver, hematological, infectious, skin, neurological or psychiatric disease

Type de données

boolean

Alias
UMLS CUI [1,1]
C0205082
UMLS CUI [1,2]
C0009488
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0007226
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C0264220
UMLS CUI [4,1]
C0009488
UMLS CUI [4,2]
C0022658
UMLS CUI [5,1]
C0009488
UMLS CUI [5,2]
C0023895
UMLS CUI [6,1]
C0009488
UMLS CUI [6,2]
C0027765
UMLS CUI [7,1]
C0009488
UMLS CUI [7,2]
C0018939
UMLS CUI [8,1]
C0009488
UMLS CUI [8,2]
C0151317
UMLS CUI [9,1]
C0009488
UMLS CUI [9,2]
C0275518
UMLS CUI [10,1]
C0009488
UMLS CUI [10,2]
C0037274
UMLS CUI [11,1]
C0009488
UMLS CUI [11,2]
C0004936
recent (< 12 months) or foreseen participation during this study in other clinical studies involving any nature of drugs or studies of any kind of intervention, unless there may be a direct benefit to the research subject, as per cns/ms resolution 251/97, item iii.j.
Description

recent or foreseen participation during this study in other clinical studies involving any nature of drugs or studies of any kind of intervention, unless there may be a direct benefit to the research subject

Type de données

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C3274035
UMLS CUI [2,1]
C0681842
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C0205394
UMLS CUI [2,4]
C3274035
UMLS CUI [3,1]
C0332300
UMLS CUI [3,2]
C0814225
UMLS CUI [3,3]
C2348568
intolerability or allergy to any of the components of the filgrastim formulations evaluated in the study.
Description

intolerability or allergy to any of the components of the filgrastim formulations evaluated in the study

Type de données

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C1705248
UMLS CUI [1,3]
C0210630
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1705248
UMLS CUI [2,3]
C0210630
pregnancy or lactation (patients of childbearing potential must have a negative blood pregnancy test on the 7 days prior to the randomization).
Description

pregnancy or lactation (patients of childbearing potential must have a negative blood pregnancy test on the 7 days prior to the randomization)

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0022925
UMLS CUI [3,1]
C0332185
UMLS CUI [3,2]
C3831118
UMLS CUI [3,3]
C0430061
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Similar models

Eligibility Neutropenia in Breast Cancer NCT01079676

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
signed informed consent form
Item
signed icf;
boolean
C0021430 (UMLS CUI [1])
diagnosis confirmed by anatomic pathology examination (cytology or histopathology) of breast cancer
Item
diagnosis confirmed by anatomic pathology examination (cytology or histopathology) of breast cancer;
boolean
C0678222 (UMLS CUI [1,1])
C1265900 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2,1])
C0449575 (UMLS CUI [2,2])
clinical or imaging confirmation of TNM Breast Tumor staging
Item
clinical or imaging confirmation of stage II to IV disease, according to the tnm classification;
boolean
C1456356 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C0011923 (UMLS CUI [2,1])
C0474926 (UMLS CUI [2,2])
indication for chemotherapy with one of the eligible regimens except for relative dose adjustments in the first cycle
Item
indication for chemotherapy with one of the eligible regimens, as long as the treatment in the first cycle is planned as full dose (without adjustments relative to the original regimen)
boolean
C3146298 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
C0332300 (UMLS CUI [2,1])
C2826232 (UMLS CUI [2,2])
C0205435 (UMLS CUI [2,3])
C1302181 (UMLS CUI [2,4])
performance status on the zubrod scale
Item
performance status from 0 to 1 on the zubrod scale
boolean
C3714786 (UMLS CUI [1])
no more than one previous chemotherapeutic regimen for metastatic disease
Item
no more than one previous chemotherapeutic regimen for metastatic disease
boolean
C0205156 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
C0332300 (UMLS CUI [1,4])
C0439064 (UMLS CUI [1,5])
proper organic functions, as indicated by: anc >1500/mm3, platelet count >150000/mm3, serum creatinine <1,2 mg/dl, bilirubins and transaminases (aspartate aminotransferase [ast] and alanine aminotransferase [alt]) <1.5 times the upper limit of normal
Item
proper organic functions, as indicated by all the following conditions: anc >1500/mm3, platelet count >150000/mm3, serum creatinine <1,2 mg/dl, bilirubins and transaminases (aspartate aminotransferase [ast] and alanine aminotransferase [alt]) <1.5 times the upper limit of normal
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
C0005437 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
C0201836 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
forecast of use of antibiotics, antifungal or antiviral in the first cycle of chemotherapy
Item
forecast of prophylactic or therapeutic use of antibiotics, antifungal or antiviral in the first cycle of chemotherapy;
boolean
C0681842 (UMLS CUI [1,1])
C0003232 (UMLS CUI [1,2])
C0205435 (UMLS CUI [1,3])
C1302181 (UMLS CUI [1,4])
C0681842 (UMLS CUI [2,1])
C0003308 (UMLS CUI [2,2])
C0205435 (UMLS CUI [2,3])
C1302181 (UMLS CUI [2,4])
C0681842 (UMLS CUI [3,1])
C2363964 (UMLS CUI [3,2])
C0205435 (UMLS CUI [3,3])
C1302181 (UMLS CUI [3,4])
previous radiotherapy involving pelvis or recent radiotherapy of any site
Item
previous radiotherapy involving pelvis or radiotherapy of any site on the last 6 weeks before randomization;
boolean
C0205156 (UMLS CUI [1,1])
C1536155 (UMLS CUI [1,2])
C0332185 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
history of bone marrow transplantation
Item
history of bone marrow transplantation (as receptor)
boolean
C0005961 (UMLS CUI [1])
presence of other neoplasias, with the exception of in situ cervical carcinoma, in situ bladder carcinoma, cutaneous spinocellular carcinoma properly treated, t1 vocal cords cancer under remission or previous malignant neoplasia treated more than 5 years before the recruitment and without relapse;
Item
presence of other neoplasias, with the exception of in situ cervical carcinoma, in situ bladder carcinoma, cutaneous basal cell carcinoma properly treated, cutaneous spinocellular carcinoma properly treated, t1 vocal cords cancer under remission or previous malignant neoplasia treated more than 5 years before the recruitment and without relapse;
boolean
C0205394 (UMLS CUI [1,1])
C0027651 (UMLS CUI [1,2])
C0332300 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C0332300 (UMLS CUI [3,1])
C0007099 (UMLS CUI [3,2])
C0005682 (UMLS CUI [3,3])
C0332300 (UMLS CUI [4,1])
C0007117 (UMLS CUI [4,2])
C0087111 (UMLS CUI [4,3])
C0205410 (UMLS CUI [4,4])
C0332300 (UMLS CUI [5,1])
C0553723 (UMLS CUI [5,2])
C0087111 (UMLS CUI [5,3])
C0205410 (UMLS CUI [5,4])
C0332300 (UMLS CUI [6,1])
C0042930 (UMLS CUI [6,2])
C0006826 (UMLS CUI [6,3])
C0475372 (UMLS CUI [6,4])
C0544452 (UMLS CUI [6,5])
C0332300 (UMLS CUI [7,1])
C0006826 (UMLS CUI [7,2])
C0205156 (UMLS CUI [7,3])
C0087111 (UMLS CUI [7,4])
C0332300 (UMLS CUI [8,1])
C0006826 (UMLS CUI [8,2])
C0332288 (UMLS CUI [8,3])
C0035020 (UMLS CUI [8,4])
presence of severe comorbidities, such as cardiovascular, chronic respiratory, kidney, liver, hematological, infectious, skin, neurological or psychiatric disease
Item
presence of severe comorbidities, such as cardiovascular, chronic respiratory, kidney, liver, neurological, hematological, infectious, skin, neurological or psychiatric disease
boolean
C0205082 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
C0009488 (UMLS CUI [2,1])
C0007226 (UMLS CUI [2,2])
C0009488 (UMLS CUI [3,1])
C0264220 (UMLS CUI [3,2])
C0009488 (UMLS CUI [4,1])
C0022658 (UMLS CUI [4,2])
C0009488 (UMLS CUI [5,1])
C0023895 (UMLS CUI [5,2])
C0009488 (UMLS CUI [6,1])
C0027765 (UMLS CUI [6,2])
C0009488 (UMLS CUI [7,1])
C0018939 (UMLS CUI [7,2])
C0009488 (UMLS CUI [8,1])
C0151317 (UMLS CUI [8,2])
C0009488 (UMLS CUI [9,1])
C0275518 (UMLS CUI [9,2])
C0009488 (UMLS CUI [10,1])
C0037274 (UMLS CUI [10,2])
C0009488 (UMLS CUI [11,1])
C0004936 (UMLS CUI [11,2])
recent or foreseen participation during this study in other clinical studies involving any nature of drugs or studies of any kind of intervention, unless there may be a direct benefit to the research subject
Item
recent (< 12 months) or foreseen participation during this study in other clinical studies involving any nature of drugs or studies of any kind of intervention, unless there may be a direct benefit to the research subject, as per cns/ms resolution 251/97, item iii.j.
boolean
C0332185 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C3274035 (UMLS CUI [1,4])
C0681842 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
C3274035 (UMLS CUI [2,4])
C0332300 (UMLS CUI [3,1])
C0814225 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
intolerability or allergy to any of the components of the filgrastim formulations evaluated in the study
Item
intolerability or allergy to any of the components of the filgrastim formulations evaluated in the study.
boolean
C1744706 (UMLS CUI [1,1])
C1705248 (UMLS CUI [1,2])
C0210630 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C1705248 (UMLS CUI [2,2])
C0210630 (UMLS CUI [2,3])
pregnancy or lactation (patients of childbearing potential must have a negative blood pregnancy test on the 7 days prior to the randomization)
Item
pregnancy or lactation (patients of childbearing potential must have a negative blood pregnancy test on the 7 days prior to the randomization).
boolean
C0032961 (UMLS CUI [1])
C0022925 (UMLS CUI [2])
C0332185 (UMLS CUI [3,1])
C3831118 (UMLS CUI [3,2])
C0430061 (UMLS CUI [3,3])
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