ID

42024

Description

Study documentation part: Pre-Treatment This is a phase III study of BMS-354825 in subjects with chronic myelogenous leukemia in accelerated phase, or in myeloid or lymphoid blast phase or with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia who are resistant or intolerant to imatinib mesylate (Gleevec).Trial Number: NCT00123487. Drug: dasatinib. Phase 3.

Keywords

Versions (4)
  1. 7/6/15 7/6/15 -
  2. 8/6/15 8/6/15 -
  3. 3/15/21 3/15/21 - Dr. rer. medic Philipp Neuhaus
  4. 9/20/21 9/20/21 -
Uploaded on

March 15, 2021

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Advanced Chronic Myelogenous Leukemia (CML) NCT00123487 – Pre-Treatment

English

General Medical History

8 forms  
SYSTEM
Description

SYSTEM

Alias
UMLS CUI-1
C0182148
Head, eyes, ears, nose and throat:
Description

Head, eyes, ears, nose and throat

Data type

text

Alias
UMLS CUI-1
C0018670
UMLS CUI-2
C0015392
UMLS CUI-3
C2951063
UMLS CUI-4
C0028429
UMLS CUI-5
C0426483
Cardiovascular:
Description

Cardiovascular

Data type

text

Alias
UMLS CUI-1
C0007226
Peripheral Vascular:
Description

Peripheral Vascular

Data type

text

Alias
UMLS CUI-1
C2053830
Respiratory:
Description

Respiratory

Data type

text

Alias
UMLS CUI-1
C0035237
Gastrointestinal
Description

Gastrointestinal

Data type

text

Alias
UMLS CUI-1
C0521362
Hepatobiliary:
Description

Hepatobiliary

Data type

text

Alias
UMLS CUI-1
C0267792
Renal:
Description

Renal

Data type

text

Alias
UMLS CUI-1
C0022646
Genitourinary:
Description

Genitourinary

Data type

text

Alias
UMLS CUI-1
C0030705
UMLS CUI-2
C0031809
UMLS CUI-3
C2709259
UMLS CUI-4
C0449438
Endocrine-Metabolic:
Description

Endocrine-Metabolic

Data type

text

Alias
UMLS CUI-1
C0694452
UMLS CUI-2
C2976854
UMLS CUI-3
C2359470
Hematologic- Lymphatic:
Description

Hematologic- Lymphatic

Data type

text

Alias
UMLS CUI-1
C0221130
UMLS CUI-2
C0229889
Musculoskeletal:
Description

Musculoskeletal

Data type

text

Alias
UMLS CUI-1
C0026860
Dermatologic:
Description

Dermatologic

Data type

text

Alias
UMLS CUI-1
C0037274
Neurologic:
Description

Neurologic

Data type

text

Alias
UMLS CUI-1
C0027763
Psychiatric:
Description

Psychiatric

Data type

text

Alias
UMLS CUI-1
C0004936
Allergies:
Description

Allergies

Data type

text

Alias
UMLS CUI-1
C0020517
Neoplasia:
Description

Neoplasia

Data type

text

Alias
UMLS CUI-1
C1882062
Alcohol use:
Description

Alcohol use

Data type

text

Alias
UMLS CUI-1
C0001948
Tobacco use:
Description

Tobacco use

Data type

text

Alias
UMLS CUI-1
C0543414
Drug abuse:
Description

Drug abuse

Data type

text

Alias
UMLS CUI-1
C0013146
Other:
Description

Other

Data type

text

Alias
UMLS CUI-1
C0205394
Please specify (only for the systems answered with yes):
Description

Please specify (only for the systems answered with yes)

Data type

text

Alias
UMLS CUI-1
C2348235
INITIAL LEUKEMIA DIAGNOSIS
Description

INITIAL LEUKEMIA DIAGNOSIS

Date of initial CML diagnosis:
Description

Date of initial CML diagnosis

Data type

date

Alias
UMLS CUI-1
C0279899
Date of initial Ph + ALL Diagnosis:
Description

Date of initial Ph + ALL Diagnosis

Data type

date

Alias
UMLS CUI-1
C0279862
UMLS CUI-2
C0279890
Date of onset of advanced phase:
Description

Date of onset of advanced phase

Data type

date

Alias
UMLS CUI-1
C0205179
CURRENT DISEASE STATUS
Description

CURRENT DISEASE STATUS

Alias
UMLS CUI-1
C0012634
UMLS CUI-2
C0449438
Accelerated Phase CML:
Description

Accelerated Phase CML

Data type

boolean

Alias
UMLS CUI-1
C0023472
Ph+ ALL:
Description

Ph+ ALL

Data type

boolean

Alias
UMLS CUI-1
C0279890
UMLS CUI-2
C0279862
Myeloid Blast CML:
Description

Myeloid Blast CML

Data type

boolean

Alias
UMLS CUI-1
C0005699
Lymphoid blast CML:
Description

Lymphoid blast CML

Data type

boolean

Chronic phase with history of accelerated or blast phase:
Description

CHRONIC PHASE WITH HISTORY OF ACCELERATED OR BLAST PHASE

Data type

boolean

Alias
UMLS CUI-1
C0457343
UMLS CUI-2
C0005699
Chronic phase with clonal evolution:
Description

CHRONIC PHASE WITH CLONAL EVOLUTION

Data type

boolean

Alias
UMLS CUI-1
C0457343
UMLS CUI-2
C1516669
EXTRAMEDULLARY INVOLVEMENT
Description

EXTRAMEDULLARY INVOLVEMENT

Alias
UMLS CUI-1
C1517060
UMLS CUI-2
C1314939
Date of Assessment:
Description

Date of Assessment

Data type

date

Alias
UMLS CUI-1
C1516048
Is extramedullary disease present?
Description

Is extramedullary disease present?

Data type

boolean

Alias
UMLS CUI-1
C1517060
UMLS CUI-2
C0012634
If yes, provide site code(s) from below: 1 = SKIN/SOFT TISSUE 2 = BONE 3 = VISCERAL, LUNG 4 = VISCERAL, LIVER 5 = VISCERAL, OTHER 6 = LYMPH NODE 8 = BONE MARROW 9 = CNS 10 = MEDIASTINUM 14 = EFFUSION 16 = SPLEEN 18 = INTESTINE 19 = ASCITES 25 = PELVIS 26 = PERITONEUM 34 = OVARY 36 = PLEURA 37 = GASTRIC 98 = OTHER
Description

If yes, provide site code(s) from below: 1 = SKIN/SoFT TISSUE 2 = BoNE 3 = VISCERAL, LUNG 4 = VISCERAL, LIVER 5 = VISCERAL, OTHER 6 = LYMPH NODE 8 = BONE MARROW 9 = CNS 10 = MEDIASTINUM 14 = EFFUSION 16 = SPLEEN 18 = INTESTINE 19 = ASCITES 25 = PELVIS 26 = PERITONEUM 34 = OVARY 36 = PLEURA 37 = GASTRIC 98 = OTHER

Data type

integer

Alias
UMLS CUI-1
C1515974
UMLS CUI-2
C0221198
UMLS CUI-3
C0220825
UMLS CUI-4
C1513040
CHEST X-RAY
Description

CHEST X-RAY

Alias
UMLS CUI-1
C0039985
Was a chest X-ray performed?
Description

CHEST X-RAY

Data type

boolean

Alias
UMLS CUI-1
C0039985
Date of chest X- ray, if performed already:
Description

Date of chest X- ray

Data type

date

Alias
UMLS CUI-1
C0011008
Interpretation of chest X- ray:
Description

INTERPRETATION:

Data type

text

Alias
UMLS CUI-1
C0459471
Specify clinical relevant abnormalities:
Description

SPECIFY CLINICALLY RELEVANT ABNORMALITIES

Data type

text

Alias
UMLS CUI-1
C2348235
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Similar models

General Medical History

8 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
SYSTEM
C0182148 (UMLS CUI-1)
Item
Head, eyes, ears, nose and throat:
text
C0018670 (UMLS CUI-1)
C0015392 (UMLS CUI-2)
C2951063 (UMLS CUI-3)
C0028429 (UMLS CUI-4)
C0426483 (UMLS CUI-5)
Head, eyes, ears, nose and throat
Code List
Head, eyes, ears, nose and throat:
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown (3)
Item
Cardiovascular:
text
C0007226 (UMLS CUI-1)
Cardiovascular
Code List
Cardiovascular:
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown (3)
Item
Peripheral Vascular:
text
C2053830 (UMLS CUI-1)
PERIPHERAL VASCULAR
Code List
Peripheral Vascular:
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown (3)
Item
Respiratory:
text
C0035237 (UMLS CUI-1)
RESPIRATORY
Code List
Respiratory:
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown (3)
Item
Gastrointestinal
text
C0521362 (UMLS CUI-1)
GASTROINTESTINAL
Code List
Gastrointestinal
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown (3)
Item
Hepatobiliary:
text
C0267792 (UMLS CUI-1)
HEPATOBILIARY
Code List
Hepatobiliary:
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown (3)
Item
Renal:
text
C0022646 (UMLS CUI-1)
RENAL
Code List
Renal:
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown (3)
Item
Genitourinary:
text
C0030705 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
C2709259 (UMLS CUI-3)
C0449438 (UMLS CUI-4)
GENITOURINARY
Code List
Genitourinary:
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown (3)
Item
Endocrine-Metabolic:
text
C0694452 (UMLS CUI-1)
C2976854 (UMLS CUI-2)
C2359470 (UMLS CUI-3)
ENDOCRINE METABOLIC
Code List
Endocrine-Metabolic:
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown (3)
Item
Hematologic- Lymphatic:
text
C0221130 (UMLS CUI-1)
C0229889 (UMLS CUI-2)
HEMATOLOGIC-LYMPHATIC
Code List
Hematologic- Lymphatic:
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown (3)
Item
Musculoskeletal:
text
C0026860 (UMLS CUI-1)
MUSCULOSKELETAL
Code List
Musculoskeletal:
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown (3)
Item
Dermatologic:
text
C0037274 (UMLS CUI-1)
DERMATOLOGIC
Code List
Dermatologic:
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown (3)
Item
Neurologic:
text
C0027763 (UMLS CUI-1)
NEUROLOGIC
Code List
Neurologic:
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown (3)
Item
Psychiatric:
text
C0004936 (UMLS CUI-1)
PSYCHIATRIC
Code List
Psychiatric:
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown (3)
Item
Allergies:
text
C0020517 (UMLS CUI-1)
ALLERGIES
Code List
Allergies:
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown (3)
Item
Neoplasia:
text
C1882062 (UMLS CUI-1)
NEOPLASIA
Code List
Neoplasia:
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown (3)
Item
Alcohol use:
text
C0001948 (UMLS CUI-1)
ALCOHOL USE
Code List
Alcohol use:
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown (3)
Item
Tobacco use:
text
C0543414 (UMLS CUI-1)
TOBACCO USE
Code List
Tobacco use:
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown (3)
Item
Drug abuse:
text
C0013146 (UMLS CUI-1)
DRUG ABUSE
Code List
Drug abuse:
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown (3)
Item
Other:
text
C0205394 (UMLS CUI-1)
OTHER
Code List
Other:
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown (3)
Specification
Item
Please specify (only for the systems answered with yes):
text
C2348235 (UMLS CUI-1)
Item Group
INITIAL LEUKEMIA DIAGNOSIS
CML DIAGNOSIS
Item
Date of initial CML diagnosis:
date
C0279899 (UMLS CUI-1)
Ph+ ALL DIAGNOSIS
Item
Date of initial Ph + ALL Diagnosis:
date
C0279862 (UMLS CUI-1)
C0279890 (UMLS CUI-2)
ADVANCED PHASE
Item
Date of onset of advanced phase:
date
C0205179 (UMLS CUI-1)
Item Group
CURRENT DISEASE STATUS
C0012634 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
ACCELERATED PHASE CML
Item
Accelerated Phase CML:
boolean
C0023472 (UMLS CUI-1)
Ph+ ALL
Item
Ph+ ALL:
boolean
C0279890 (UMLS CUI-1)
C0279862 (UMLS CUI-2)
MYELOID BLAST CML
Item
Myeloid Blast CML:
boolean
C0005699 (UMLS CUI-1)
LYMPHOID BLAST CML
Item
Lymphoid blast CML:
boolean
ACCELERATED OR BLAST PHASE
Item
Chronic phase with history of accelerated or blast phase:
boolean
C0457343 (UMLS CUI-1)
C0005699 (UMLS CUI-2)
CLONAL EVOLUTION
Item
Chronic phase with clonal evolution:
boolean
C0457343 (UMLS CUI-1)
C1516669 (UMLS CUI-2)
Item Group
EXTRAMEDULLARY INVOLVEMENT
C1517060 (UMLS CUI-1)
C1314939 (UMLS CUI-2)
Assessment
Item
Date of Assessment:
date
C1516048 (UMLS CUI-1)
EXTRAMEDULLARY DISEASE
Item
Is extramedullary disease present?
boolean
C1517060 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
SITE CODE
Item
If yes, provide site code(s) from below: 1 = SKIN/SOFT TISSUE 2 = BONE 3 = VISCERAL, LUNG 4 = VISCERAL, LIVER 5 = VISCERAL, OTHER 6 = LYMPH NODE 8 = BONE MARROW 9 = CNS 10 = MEDIASTINUM 14 = EFFUSION 16 = SPLEEN 18 = INTESTINE 19 = ASCITES 25 = PELVIS 26 = PERITONEUM 34 = OVARY 36 = PLEURA 37 = GASTRIC 98 = OTHER
integer
C1515974 (UMLS CUI-1)
C0221198 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
C1513040 (UMLS CUI-4)
Item Group
CHEST X-RAY
C0039985 (UMLS CUI-1)
CHEST X-RAY
Item
Was a chest X-ray performed?
boolean
C0039985 (UMLS CUI-1)
Date
Item
Date of chest X- ray, if performed already:
date
C0011008 (UMLS CUI-1)
Item
Interpretation of chest X- ray:
text
C0459471 (UMLS CUI-1)
INTERPRETATION
Code List
Interpretation of chest X- ray:
CL Item
Normal (1)
CL Item
Abnormal (2)
Specification
Item
Specify clinical relevant abnormalities:
text
C2348235 (UMLS CUI-1)
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