ID

11830

Beschreibung

Study documentation part: End of 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

Stichworte

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  1. 06.08.15 06.08.15 -
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6. August 2015

DOI

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Advanced Chronic Myelogenous Leukemia (CML) NCT00123487- End of Treatment

Englisch

Advanced Chronic Myelogenous Leukemia (CML) NCT00123487- End of Treatment

5 Formulare  
SUBJECT DETAILS
Beschreibung

SUBJECT DETAILS

Subject number :
Beschreibung

Subject number

Datentyp

integer

Subject initial:
Beschreibung

Subject initial

Datentyp

text

Alias
UMLS CUI-1
C2986440
Visit date:
Beschreibung

Visit date

Datentyp

date

Alias
UMLS CUI-1
C0011008
Site number:
Beschreibung

Site number:

Datentyp

integer

Alias
UMLS CUI-1
C0008972
UMLS CUI-2
C0205145
UMLS CUI-3
C1709628
UMLS CUI-4
C0600091
UMLS CUI-5
C0237753
VITAL SIGNS
Beschreibung

VITAL SIGNS

Alias
UMLS CUI-1
C0518766
Were vital signs taken?
Beschreibung

Were vital signs taken?

Datentyp

boolean

Alias
UMLS CUI-1
C0518766
Date:
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI-1
C0011008
Position:
Beschreibung

Position

Datentyp

text

Alias
UMLS CUI-1
C0733755
Blood pressure systolic (in mm Hg):
Beschreibung

Blood pressure systolic

Datentyp

float

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure diastolic (in mm Hg):
Beschreibung

Blood pressure diastolic

Datentyp

float

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate (in bpm):
Beschreibung

Heart rate

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
PHYSICAL MEASUREMENTS
Beschreibung

PHYSICAL MEASUREMENTS

Alias
UMLS CUI-1
C0205485
UMLS CUI-2
C0242485
Were any physical measurements taken?
Beschreibung

Were any physical measurements taken?

Datentyp

boolean

Alias
UMLS CUI-1
C0205485
UMLS CUI-2
C0242485
Date of measurement:
Beschreibung

Date of measurement

Datentyp

date

Alias
UMLS CUI-1
C0011008
Weight (in Kg):
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • Kg
Alias
UMLS CUI [1]
C0005910
Kg
Performance status (ECOG):
Beschreibung

Performance status (ECOG)

Datentyp

text

Alias
UMLS CUI-1
C1520224
EXTRAMEDULLARY INVOLVEMENT
Beschreibung

EXTRAMEDULLARY INVOLVEMENT

Alias
UMLS CUI-1
C1517060
UMLS CUI-2
C1314939
Date of assessment:
Beschreibung

Date of assessment

Datentyp

date

Alias
UMLS CUI-1
C0011008
Is extramedullary disease present?
Beschreibung

Is extramedullary disease present?

Datentyp

boolean

Alias
UMLS CUI-1
C1517060
UMLS CUI-2
C0012634
f yes, please provide the side 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
Beschreibung

f yes, please provide the side 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

Datentyp

text

Alias
UMLS CUI-1
C1515974
UMLS CUI-2
C0221198
UMLS CUI-3
C0220825
UMLS CUI-4
C1513040
PROGRESSION
Beschreibung

PROGRESSION

Alias
UMLS CUI-1
C0242656
Did the subject progress?
Beschreibung

Did the subject progress?

Datentyp

boolean

Alias
UMLS CUI-1
C0242656
Date of progression:
Beschreibung

Date of progression

Datentyp

date

Alias
UMLS CUI-1
C0011008
Reason for progression:
Beschreibung

Reason for progression

Datentyp

text

Alias
UMLS CUI-1
C0392360
BEST OVERALL HEMATOLOGIC RESPONSE
Beschreibung

BEST OVERALL HEMATOLOGIC RESPONSE

Alias
UMLS CUI-1
C0205488
UMLS CUI-2
C0871261
UMLS CUI-3
C0939537
Was the hematologic response confirmed?
Beschreibung

Was the hematologic response confirmed?

Datentyp

boolean

Alias
UMLS CUI-1
C0026764
UMLS CUI-2
C0871261
UMLS CUI-3
C0332152
UMLS CUI-4
C0332307
Complete hematologic response (CHR):
Beschreibung

Complete hematologic response

Datentyp

boolean

Alias
UMLS CUI-1
C0205488
UMLS CUI-2
C0871261
UMLS CUI-3
C0939537
If yes, date of CHR:
Beschreibung

If yes, date of CHR

Datentyp

date

Alias
UMLS CUI-1
C0011008
No evidence of leukemia (NEL):
Beschreibung

No evidence of leukemia (NEL)

Datentyp

boolean

Alias
UMLS CUI-1
C0023418
If yes, date of NEL:
Beschreibung

If yes, date of NEL

Datentyp

date

Alias
UMLS CUI-1
C0011008
Return to chronic phase (RTC):
Beschreibung

Return to chronic phase (RTC)

Datentyp

boolean

Alias
UMLS CUI-1
C0457343
UMLS CUI-2
C1516669
If yes, date of RTC:
Beschreibung

If yes, date of RTC

Datentyp

date

Alias
UMLS CUI-1
C0011008
Minor hematologic response (MiHR):
Beschreibung

Minor hematologic response

Datentyp

boolean

Alias
UMLS CUI-1
C0026764
UMLS CUI-2
C0871261
UMLS CUI-3
C0332152
UMLS CUI-4
C0332307
No hematologic response:
Beschreibung

No hematologic response

Datentyp

boolean

Alias
UMLS CUI-1
C0026764
UMLS CUI-2
C0871261
UMLS CUI-3
C0332152
UMLS CUI-4
C0332307
Unable to determine:
Beschreibung

Unable to determine

Datentyp

text

Alias
UMLS CUI-1
C1148554
Please specify "The reason other than toxicity or progression":
Beschreibung

Please specify "The reason other than toxicity or progression":

Datentyp

text

Alias
UMLS CUI-1
C2348235
BEST OVERALL CYTOGENETIC RESPONSE
Beschreibung

BEST OVERALL CYTOGENETIC RESPONSE

Alias
UMLS CUI-1
C0332307
UMLS CUI-2
C1704632
UMLS CUI-3
C0314603
Date of best cytogenetic response:
Beschreibung

Date of best cytogenetic response

Datentyp

date

Alias
UMLS CUI-1
C0011008
Best cytogenetic response:
Beschreibung

Best cytogenetic response

Datentyp

text

Alias
UMLS CUI-1
C0332307
UMLS CUI-2
C1704632
UMLS CUI-3
C0314603
No cytogenetic response:
Beschreibung

No cytogenetic response

Datentyp

boolean

Alias
UMLS CUI-1
C0332307
UMLS CUI-2
C1704632
UMLS CUI-3
C0314603
Unable to determine:
Beschreibung

Unable to determine

Datentyp

text

Alias
UMLS CUI-1
C1148554
Please specify "The reason other than toxicity or progression":
Beschreibung

Please specify "The reason other than toxicity or progression"

Datentyp

text

Alias
UMLS CUI-1
C2348235
EXTERNAL DATA TRACKING
Beschreibung

EXTERNAL DATA TRACKING

Alias
UMLS CUI-1
C1516800
Were any of the following protocol specified activities performed?
Beschreibung

Were any of the following protocol specified activities performed?

Datentyp

boolean

Alias
UMLS CUI-1
C1516800
If yes, provide date and time:
Beschreibung

If yes, provide date and time

Datentyp

datetime

Alias
UMLS CUI-1
C0011008
Mutation analysis:
Beschreibung

Mutation analysis

Datentyp

boolean

Alias
UMLS CUI-1
C0796357
END OF TREATMENT STATUS
Beschreibung

END OF TREATMENT STATUS

Alias
UMLS CUI-1
C0749659
Date of subject off treatment:
Beschreibung

Date of subject off treatment

Datentyp

date

Alias
UMLS CUI-1
C0011008
Reason for discontinuing:
Beschreibung

Reason for discontinuing

Datentyp

text

Alias
UMLS CUI-1
C0392360
For the reasons with "Specify", please mention the details:
Beschreibung

For the reasons with "Specify", please mention the details:

Datentyp

text

Alias
UMLS CUI-1
C2348235
SUBJECT STATUS
Beschreibung

SUBJECT STATUS

Alias
UMLS CUI-1
C2348568
Will the subject continue to be followed?
Beschreibung

Will the subject continue to be followed?

Datentyp

boolean

Alias
UMLS CUI-1
C2348568
If no, please indicate the primary reason:
Beschreibung

If no, please indicate the primary reason

Datentyp

text

Alias
UMLS CUI-1
C0392360
In case of "Lost to follow-up", please mention the date of last contact:
Beschreibung

In case of "Lost to follow-up", please mention the date of last contact

Datentyp

date

Alias
UMLS CUI-1
C0011008
For the reasons with "Specify", please mention the details:
Beschreibung

For the reasons with "Specify", please mention the details

Datentyp

text

Alias
UMLS CUI-1
C2348235
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Ähnliche Modelle

Advanced Chronic Myelogenous Leukemia (CML) NCT00123487- End of Treatment

5 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
SUBJECT DETAILS
Subject number
Item
Subject number :
integer
Subject initial
Item
Subject initial:
text
C2986440 (UMLS CUI-1)
DATE
Item
Visit date:
date
C0011008 (UMLS CUI-1)
Site number
Item
Site number:
integer
C0008972 (UMLS CUI-1)
C0205145 (UMLS CUI-2)
C1709628 (UMLS CUI-3)
C0600091 (UMLS CUI-4)
C0237753 (UMLS CUI-5)
Item Group
VITAL SIGNS
C0518766 (UMLS CUI-1)
Vital signs
Item
Were vital signs taken?
boolean
C0518766 (UMLS CUI-1)
DATE
Item
Date:
date
C0011008 (UMLS CUI-1)
Item
Position:
text
C0733755 (UMLS CUI-1)
POSITION
Code List
Position:
CL Item
Sitting (1)
CL Item
Standing (2)
CL Item
Supine (3)
BLOOD PRESSURE SYSTOLIC
Item
Blood pressure systolic (in mm Hg):
float
C0871470 (UMLS CUI [1])
BLOOD PRESSURE DIASTOLIC
Item
Blood pressure diastolic (in mm Hg):
float
C0428883 (UMLS CUI [1])
HEART RATE
Item
Heart rate (in bpm):
integer
C0018810 (UMLS CUI [1])
Item Group
PHYSICAL MEASUREMENTS
C0205485 (UMLS CUI-1)
C0242485 (UMLS CUI-2)
Physical measurements
Item
Were any physical measurements taken?
boolean
C0205485 (UMLS CUI-1)
C0242485 (UMLS CUI-2)
DATE
Item
Date of measurement:
date
C0011008 (UMLS CUI-1)
Weight
Item
Weight (in Kg):
float
C0005910 (UMLS CUI [1])
ECOG
Item
Performance status (ECOG):
text
C1520224 (UMLS CUI-1)
Item Group
EXTRAMEDULLARY INVOLVEMENT
C1517060 (UMLS CUI-1)
C1314939 (UMLS CUI-2)
DATE
Item
Date of assessment:
date
C0011008 (UMLS CUI-1)
Extramedullary disease
Item
Is extramedullary disease present?
boolean
C1517060 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
SITE CODE
Item
f yes, please provide the side 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
text
C1515974 (UMLS CUI-1)
C0221198 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
C1513040 (UMLS CUI-4)
Item Group
PROGRESSION
C0242656 (UMLS CUI-1)
Progression
Item
Did the subject progress?
boolean
C0242656 (UMLS CUI-1)
DATE
Item
Date of progression:
date
C0011008 (UMLS CUI-1)
Item
Reason for progression:
text
C0392360 (UMLS CUI-1)
REASON
Code List
Reason for progression:
CL Item
10 Loss of hematologic response (CHR, NEL or RTC) (1)
CL Item
12 Development of blast phase CML (2)
CL Item
9 No decrease from baseline percent blasts despite maximum dose (3)
CL Item
18 Development of new extra- medullary sites (other than liver or spleen) (4)
Item Group
BEST OVERALL HEMATOLOGIC RESPONSE
C0205488 (UMLS CUI-1)
C0871261 (UMLS CUI-2)
C0939537 (UMLS CUI-3)
HEMATOLOGIC RESPONSE
Item
Was the hematologic response confirmed?
boolean
C0026764 (UMLS CUI-1)
C0871261 (UMLS CUI-2)
C0332152 (UMLS CUI-3)
C0332307 (UMLS CUI-4)
HEMATOLOGIC RESPONSE
Item
Complete hematologic response (CHR):
boolean
C0205488 (UMLS CUI-1)
C0871261 (UMLS CUI-2)
C0939537 (UMLS CUI-3)
DATE
Item
If yes, date of CHR:
date
C0011008 (UMLS CUI-1)
leukemia
Item
No evidence of leukemia (NEL):
boolean
C0023418 (UMLS CUI-1)
DATE
Item
If yes, date of NEL:
date
C0011008 (UMLS CUI-1)
Chronic phase
Item
Return to chronic phase (RTC):
boolean
C0457343 (UMLS CUI-1)
C1516669 (UMLS CUI-2)
DATE
Item
If yes, date of RTC:
date
C0011008 (UMLS CUI-1)
HEMATOLOGIC RESPONSE
Item
Minor hematologic response (MiHR):
boolean
C0026764 (UMLS CUI-1)
C0871261 (UMLS CUI-2)
C0332152 (UMLS CUI-3)
C0332307 (UMLS CUI-4)
HEMATOLOGIC RESPONSE
Item
No hematologic response:
boolean
C0026764 (UMLS CUI-1)
C0871261 (UMLS CUI-2)
C0332152 (UMLS CUI-3)
C0332307 (UMLS CUI-4)
Item
Unable to determine:
text
C1148554 (UMLS CUI-1)
Determination
Code List
Unable to determine:
CL Item
Early death attributed to toxicity. (1)
CL Item
Early discontinuation attributed to toxicity. (2)
CL Item
No assessment due to reason other than toxicity or progression (Specify) (3)
Specification
Item
Please specify "The reason other than toxicity or progression":
text
C2348235 (UMLS CUI-1)
Item Group
BEST OVERALL CYTOGENETIC RESPONSE
C0332307 (UMLS CUI-1)
C1704632 (UMLS CUI-2)
C0314603 (UMLS CUI-3)
DATE
Item
Date of best cytogenetic response:
date
C0011008 (UMLS CUI-1)
Item
Best cytogenetic response:
text
C0332307 (UMLS CUI-1)
C1704632 (UMLS CUI-2)
C0314603 (UMLS CUI-3)
CYTOGENETIC RESPONSE
Code List
Best cytogenetic response:
CL Item
Complete cytogenetic response (CCyR) (1)
CL Item
Partial cytogenetic response (PCyR) (2)
CL Item
Minor cytogenetic response (3)
CL Item
Minimal cytogenetic response (4)
CYTOGENETIC RESPONSE
Item
No cytogenetic response:
boolean
C0332307 (UMLS CUI-1)
C1704632 (UMLS CUI-2)
C0314603 (UMLS CUI-3)
Item
Unable to determine:
text
C1148554 (UMLS CUI-1)
Determination
Code List
Unable to determine:
CL Item
Early death attributed to toxicity. (1)
CL Item
Early discontinuation attributed to toxicity. (2)
CL Item
No assessment due to reason other than toxicity or progression (Specify) (3)
Specification
Item
Please specify "The reason other than toxicity or progression":
text
C2348235 (UMLS CUI-1)
Item Group
EXTERNAL DATA TRACKING
C1516800 (UMLS CUI-1)
EXTERNAL DATA TRACKING
Item
Were any of the following protocol specified activities performed?
boolean
C1516800 (UMLS CUI-1)
DATE AND TIME
Item
If yes, provide date and time:
datetime
C0011008 (UMLS CUI-1)
MUTATION ANALYSIS
Item
Mutation analysis:
boolean
C0796357 (UMLS CUI-1)
Item Group
END OF TREATMENT STATUS
C0749659 (UMLS CUI-1)
DATE
Item
Date of subject off treatment:
date
C0011008 (UMLS CUI-1)
Item
Reason for discontinuing:
text
C0392360 (UMLS CUI-1)
REASON
Code List
Reason for discontinuing:
CL Item
Disease progression (1)
CL Item
Study drug toxicity (Specify) (2)
CL Item
Adverse event unrelated to study drug (Specify) (3)
CL Item
Subject request (4)
CL Item
Investigator request (5)
CL Item
Other (Specify) (6)
Specification
Item
For the reasons with "Specify", please mention the details:
text
C2348235 (UMLS CUI-1)
Item Group
SUBJECT STATUS
C2348568 (UMLS CUI-1)
SUBJECT STATUS
Item
Will the subject continue to be followed?
boolean
C2348568 (UMLS CUI-1)
Item
If no, please indicate the primary reason:
text
C0392360 (UMLS CUI-1)
REASON
Code List
If no, please indicate the primary reason:
CL Item
Subject withdrew consent (Specify) (1)
CL Item
Death (2)
CL Item
Lost to follow-up (3)
CL Item
Other (Specify) (4)
DATE
Item
In case of "Lost to follow-up", please mention the date of last contact:
date
C0011008 (UMLS CUI-1)
Specification
Item
For the reasons with "Specify", please mention the details:
text
C2348235 (UMLS CUI-1)
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