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Subject ID, age, height, weight, tumor grade, tumor stage, histology of tumor, tumor ER, HER2, and PR status, menopause status, tumor progression and death of participants with primary breast cancer and involved in the "Simultaneous Study of Gemcitabine-Docetaxel Combination Adjuvant Treatment, as Well as Extended Bisphosphonate and Surveillance-Trial (SUCCESS-Trial)" project.

6 Formulaires  
  1. StudyEvent: SEV1
    1. Eligibility Criteria
    2. Subject ID, consent group, subject source, and subject source ID of participants with primary breast cancer and involved in the "Simultaneous Study of Gemcitabine-Docetaxel Combination Adjuvant Treatment, as Well as Extended Bisphosphonate and Surveillance-Trial (SUCCESS-Trial)" project.
    3. Subject ID, family ID, father and mother IDs, and sex of participants with primary breast cancer and involved in the "Simultaneous Study of Gemcitabine-Docetaxel Combination Adjuvant Treatment, as Well as Extended Bisphosphonate and Surveillance-Trial (SUCCESS-Trial)" project.
    4. Sample ID, subject ID, sample source, sample source ID, and sample use variables obtained from participants with primary breast cancer and involved in the "Simultaneous Study of Gemcitabine-Docetaxel Combination Adjuvant Treatment, as Well as Extended Bisphosphonate and Surveillance-Trial (SUCCESS-Trial)" project.
    5. Subject ID, age, height, weight, tumor grade, tumor stage, histology of tumor, tumor ER, HER2, and PR status, menopause status, tumor progression and death of participants with primary breast cancer and involved in the "Simultaneous Study of Gemcitabine-Docetaxel Combination Adjuvant Treatment, as Well as Extended Bisphosphonate and Surveillance-Trial (SUCCESS-Trial)" project.
    6. Sample ID, body site where sample was collected, analyte type of samples, tumor status, and histological type of samples obtained from participants with primary breast cancer and involved in the "Simultaneous Study of Gemcitabine-Docetaxel Combination Adjuvant Treatment, as Well as Extended Bisphosphonate and Surveillance-Trial (SUCCESS-Trial)" project.
pht003007
Description

pht003007

GARNET ID
Description

garnet_id

Type de données

text

Alias
UMLS CUI [1,1]
C2348585
First randomization result for intention to treat analysis
Description

randomization1

Type de données

text

Alias
UMLS CUI [1,1]
C2718028
UMLS CUI [1,2]
C0034656
UMLS CUI [1,3]
C1274040
Overall estrogen receptor status
Description

ER_status_cumulative

Type de données

text

Alias
UMLS CUI [1,1]
C2919271
HER2/neu status
Description

HER2_status_cumulative

Type de données

text

Alias
UMLS CUI [1,1]
C1512413
Overall progesterone status
Description

PR_status_cumulative

Type de données

text

Alias
UMLS CUI [1,1]
C2919590
Age at randomization
Description

Age

Type de données

text

Unités de mesure
  • year
Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C0034656
year
Menopausal status
Description

menopause_status

Type de données

text

Alias
UMLS CUI [1,1]
C3829127
Height (to calculate BMI)
Description

height

Type de données

text

Unités de mesure
  • cm
Alias
UMLS CUI [1,1]
C0005890
cm
Weight (to calculate BMI)
Description

weight

Type de données

text

Unités de mesure
  • kg
Alias
UMLS CUI [1,1]
C0005910
kg
Grading
Description

grading

Type de données

text

Alias
UMLS CUI [1,1]
C0919553
PT according to TNM Classification
Description

stage_t

Type de données

text

Alias
UMLS CUI [1,1]
C1272834
PN according to TNM Classification
Description

stage_n

Type de données

text

Alias
UMLS CUI [1,1]
C1272833
CM according to TNM Classification
Description

stage_m

Type de données

text

Alias
UMLS CUI [1,1]
C1275856
Type of histology
Description

tumor_type

Type de données

text

Alias
UMLS CUI [1,1]
C0679557
UMLS CUI [1,2]
C0449560
Observation time for overall survival
Description

TIME_DEATH

Type de données

text

Unités de mesure
  • day
Alias
UMLS CUI [1,1]
C4086681
UMLS CUI [1,2]
C0522767
day
Overall survival status
Description

STATUS_DEATH

Type de données

text

Alias
UMLS CUI [1,1]
C3272903
UMLS CUI [1,2]
C1148433
Observation time for progression-free survival
Description

TIME_PROGRESS

Type de données

text

Unités de mesure
  • day
Alias
UMLS CUI [1,1]
C0242792
UMLS CUI [1,2]
C0522767
day
Progression-free survival status
Description

STATUS_PROGRESS

Type de données

text

Alias
UMLS CUI [1,1]
C0242792
Is there a grade 3 or grade 4 AE (leukopenia, neutropenia or febrile neutropenia) within chemo cycle 1 (yes/no)?
Description

IS_AE_CYCLE1

Type de données

text

Alias
UMLS CUI [1,1]
C2985911
UMLS CUI [1,2]
C0746883
UMLS CUI [1,3]
C0027947
UMLS CUI [1,4]
C0023530
Is there a grade 3 or grade 4 AE (leukopenia, neutropenia or febrile neutropenia) within chemo cycles 1,2,3 (yes/no)?
Description

IS_AE_CYCLE123

Type de données

text

Alias
UMLS CUI [1,1]
C2985911
UMLS CUI [1,2]
C0746883
UMLS CUI [1,3]
C0027947
UMLS CUI [1,4]
C0023530
Is there a grade 3 or grade 4 AE (leukopenia, neutropenia or febrile neutropenia) within chemo cycle 4 (yes/no)?
Description

IS_AE_CYCLE4

Type de données

text

Alias
UMLS CUI [1,1]
C2985911
UMLS CUI [1,2]
C0746883
UMLS CUI [1,3]
C0027947
UMLS CUI [1,4]
C0023530
Is there a grade 3 or grade 4 AE (leukopenia, neutropenia or febrile neutropenia) within chemo cycles 4,5,6 (yes/no)?
Description

IS_AE_CYCLE456

Type de données

text

Alias
UMLS CUI [1,1]
C2985911
UMLS CUI [1,2]
C0746883
UMLS CUI [1,3]
C0027947
UMLS CUI [1,4]
C0023530
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Similar models

Subject ID, age, height, weight, tumor grade, tumor stage, histology of tumor, tumor ER, HER2, and PR status, menopause status, tumor progression and death of participants with primary breast cancer and involved in the "Simultaneous Study of Gemcitabine-Docetaxel Combination Adjuvant Treatment, as Well as Extended Bisphosphonate and Surveillance-Trial (SUCCESS-Trial)" project.

6 Formulaires
  1. StudyEvent: SEV1
    1. Eligibility Criteria
    2. Subject ID, consent group, subject source, and subject source ID of participants with primary breast cancer and involved in the "Simultaneous Study of Gemcitabine-Docetaxel Combination Adjuvant Treatment, as Well as Extended Bisphosphonate and Surveillance-Trial (SUCCESS-Trial)" project.
    3. Subject ID, family ID, father and mother IDs, and sex of participants with primary breast cancer and involved in the "Simultaneous Study of Gemcitabine-Docetaxel Combination Adjuvant Treatment, as Well as Extended Bisphosphonate and Surveillance-Trial (SUCCESS-Trial)" project.
    4. Sample ID, subject ID, sample source, sample source ID, and sample use variables obtained from participants with primary breast cancer and involved in the "Simultaneous Study of Gemcitabine-Docetaxel Combination Adjuvant Treatment, as Well as Extended Bisphosphonate and Surveillance-Trial (SUCCESS-Trial)" project.
    5. Subject ID, age, height, weight, tumor grade, tumor stage, histology of tumor, tumor ER, HER2, and PR status, menopause status, tumor progression and death of participants with primary breast cancer and involved in the "Simultaneous Study of Gemcitabine-Docetaxel Combination Adjuvant Treatment, as Well as Extended Bisphosphonate and Surveillance-Trial (SUCCESS-Trial)" project.
    6. Sample ID, body site where sample was collected, analyte type of samples, tumor status, and histological type of samples obtained from participants with primary breast cancer and involved in the "Simultaneous Study of Gemcitabine-Docetaxel Combination Adjuvant Treatment, as Well as Extended Bisphosphonate and Surveillance-Trial (SUCCESS-Trial)" project.
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
pht003007
garnet_id
Item
GARNET ID
text
C2348585 (UMLS CUI [1,1])
Item
First randomization result for intention to treat analysis
text
C2718028 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
randomization1
Code List
First randomization result for intention to treat analysis
CL Item
FEC-DOC/Gem (AA)
CL Item
FEC-DOC (AB)
Item
Overall estrogen receptor status
text
C2919271 (UMLS CUI [1,1])
ER_status_cumulative
Code List
Overall estrogen receptor status
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
Not available (NA)
Item
HER2/neu status
text
C1512413 (UMLS CUI [1,1])
HER2_status_cumulative
Code List
HER2/neu status
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
uncertain (no FISH available) (3)
CL Item
Not available (NA)
Item
Overall progesterone status
text
C2919590 (UMLS CUI [1,1])
PR_status_cumulative
Code List
Overall progesterone status
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
Not available (NA)
Age
Item
Age at randomization
text
C0001779 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
Item
Menopausal status
text
C3829127 (UMLS CUI [1,1])
menopause_status
Code List
Menopausal status
CL Item
Premenopausal (1)
CL Item
Postmenopausal (2)
height
Item
Height (to calculate BMI)
text
C0005890 (UMLS CUI [1,1])
weight
Item
Weight (to calculate BMI)
text
C0005910 (UMLS CUI [1,1])
Item
Grading
text
C0919553 (UMLS CUI [1,1])
grading
Code List
Grading
CL Item
G1 (well differentiated) (1)
CL Item
G2 (moderately differentiated) (2)
CL Item
G3 (poorly differentiated) (3)
CL Item
Not available (NA)
Item
PT according to TNM Classification
text
C1272834 (UMLS CUI [1,1])
stage_t
Code List
PT according to TNM Classification
CL Item
pT0 (0)
CL Item
pT1 (1)
CL Item
pT2 (2)
CL Item
pT3 (3)
CL Item
pT4 (4)
CL Item
Not available (NA)
Item
PN according to TNM Classification
text
C1272833 (UMLS CUI [1,1])
stage_n
Code List
PN according to TNM Classification
CL Item
pN0 (0)
CL Item
pN1 (1)
CL Item
pN2 (2)
CL Item
pN3 (3)
CL Item
Not available (NA)
Item
CM according to TNM Classification
text
C1275856 (UMLS CUI [1,1])
stage_m
Code List
CM according to TNM Classification
CL Item
cM0 (0)
CL Item
cM1 (1)
CL Item
Not available (NA)
Item
Type of histology
text
C0679557 (UMLS CUI [1,1])
C0449560 (UMLS CUI [1,2])
tumor_type
Code List
Type of histology
CL Item
Invasive ductal (1)
CL Item
Invasive lobular (2)
CL Item
Other invasive epithelial breast cancer (3)
CL Item
Not available (NA)
TIME_DEATH
Item
Observation time for overall survival
text
C4086681 (UMLS CUI [1,1])
C0522767 (UMLS CUI [1,2])
Item
Overall survival status
text
C3272903 (UMLS CUI [1,1])
C1148433 (UMLS CUI [1,2])
STATUS_DEATH
Code List
Overall survival status
CL Item
Patient censored (0)
CL Item
Event (death) occurred (1)
TIME_PROGRESS
Item
Observation time for progression-free survival
text
C0242792 (UMLS CUI [1,1])
C0522767 (UMLS CUI [1,2])
Item
Progression-free survival status
text
C0242792 (UMLS CUI [1,1])
STATUS_PROGRESS
Code List
Progression-free survival status
CL Item
Patient censored (0)
CL Item
Event (distant metastasis, local recurrence, death) occurred (1)
Item
Is there a grade 3 or grade 4 AE (leukopenia, neutropenia or febrile neutropenia) within chemo cycle 1 (yes/no)?
text
C2985911 (UMLS CUI [1,1])
C0746883 (UMLS CUI [1,2])
C0027947 (UMLS CUI [1,3])
C0023530 (UMLS CUI [1,4])
IS_AE_CYCLE1
Code List
Is there a grade 3 or grade 4 AE (leukopenia, neutropenia or febrile neutropenia) within chemo cycle 1 (yes/no)?
CL Item
Not applicable because chemotherapy was not given (-1)
CL Item
No (0)
CL Item
Yes (1)
Item
Is there a grade 3 or grade 4 AE (leukopenia, neutropenia or febrile neutropenia) within chemo cycles 1,2,3 (yes/no)?
text
C2985911 (UMLS CUI [1,1])
C0746883 (UMLS CUI [1,2])
C0027947 (UMLS CUI [1,3])
C0023530 (UMLS CUI [1,4])
IS_AE_CYCLE123
Code List
Is there a grade 3 or grade 4 AE (leukopenia, neutropenia or febrile neutropenia) within chemo cycles 1,2,3 (yes/no)?
CL Item
Not applicable because chemotherapy was not given (-1)
CL Item
No (0)
CL Item
Yes (1)
Item
Is there a grade 3 or grade 4 AE (leukopenia, neutropenia or febrile neutropenia) within chemo cycle 4 (yes/no)?
text
C2985911 (UMLS CUI [1,1])
C0746883 (UMLS CUI [1,2])
C0027947 (UMLS CUI [1,3])
C0023530 (UMLS CUI [1,4])
IS_AE_CYCLE4
Code List
Is there a grade 3 or grade 4 AE (leukopenia, neutropenia or febrile neutropenia) within chemo cycle 4 (yes/no)?
CL Item
Not applicable because patient left study before cycle 4 of chemotherapy (-1)
CL Item
No (0)
CL Item
Yes (1)
Item
Is there a grade 3 or grade 4 AE (leukopenia, neutropenia or febrile neutropenia) within chemo cycles 4,5,6 (yes/no)?
text
C2985911 (UMLS CUI [1,1])
C0746883 (UMLS CUI [1,2])
C0027947 (UMLS CUI [1,3])
C0023530 (UMLS CUI [1,4])
IS_AE_CYCLE456
Code List
Is there a grade 3 or grade 4 AE (leukopenia, neutropenia or febrile neutropenia) within chemo cycles 4,5,6 (yes/no)?
CL Item
Not applicable because patient left study before cycle 4 of chemotherapy (-1)
CL Item
No (0)
CL Item
Yes (1)
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