ID

12749

Description

Randomized study with a run-in dose-selection phase to assess the added value of Lenalidomide in combination with standard remission-induction chemotherapy and post-remission treatment in patients aged 18-65 years with previously untreated acute myeloid leukemia (AML) or high risk myelodysplasia (MDS) (IPSS-R risk score> 4.5) Description of Form: Secondary Primary Malignancy Form With friendly permission of HOVON-Group, Prof. G. Ossenkoppele

Keywords

Versions (2)
  1. 11/11/15 11/11/15 -
  2. 12/18/15 12/18/15 -
Uploaded on

December 18, 2015

DOI

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License

Creative Commons BY-NC 3.0
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Secondary Primary Malignancy Form HOVON 132 AML/SAKK 30/13 EudraCT 2013-002843-26

English

Secondary Primary Malignancy Form (Secondary Primary Malignancy Form HOVON 132 AML/SAKK 30/13 EudraCT 2013-002843-26)

1 forms  
Report Information
Description

Report Information

Alias
UMLS CUI-1
C0684224
Type of report
Description

Type of Report Timepoint

Data type

integer

Alias
UMLS CUI [1,1]
C1276413
UMLS CUI [1,2]
C2348792
Date report
Description

Date report

Data type

date

Measurement units
  • dd/mm/yyyy
Alias
UMLS CUI [1]
C1302584
dd/mm/yyyy
Date of birth
Description

Date of birth

Data type

date

Measurement units
  • dd/mm/yyyy
Alias
UMLS CUI [1]
C0421451
dd/mm/yyyy
Second Primary Malignancy Information
Description

Second Primary Malignancy Information

Alias
UMLS CUI-1
C0751623
UMLS CUI-2
C1533716
Second primary malignancy
Description

Second primary malignancy

Data type

integer

Alias
UMLS CUI [1]
C0751623
*Specify
Description

Specify

Data type

text

Alias
UMLS CUI [1]
C1521902
Date of diagnosis
Description

Date of diagnosis

Data type

date

Measurement units
  • dd/mm/yyyy
Alias
UMLS CUI [1,1]
C2316983
UMLS CUI [1,2]
C0751623
UMLS CUI [2]
C1302659
dd/mm/yyyy
Date clinical diagnosis
Description

Date clinical diagnosis

Data type

date

Measurement units
  • dd/mm/yyyy
Alias
UMLS CUI [1]
C2316983
dd/mm/yyyy
Diagnosed during study phase
Description

Diagnosed during study phase

Data type

integer

Alias
UMLS CUI [1,1]
C1276413
UMLS CUI [1,2]
C2348792
Cycle Number
Description

Cycle Number

Data type

integer

Alias
UMLS CUI [1]
C2045829
Specify
Description

Specify

Data type

text

Alias
UMLS CUI [1]
C1521902
Pathology Result
Description

Pathology Result

Pathology Result (Please send in copy of report if available)
Description

Pathology Result

Data type

text

Alias
UMLS CUI [1]
C0807321
Report Information
Description

Report Information

Alias
UMLS CUI-1
C0684224
Type of Report
Description

Type of Report Timepoint

Data type

integer

Alias
UMLS CUI [1]
C2348792
Date Report
Description

Date Report

Data type

date

Measurement units
  • dd/mm/yyyy
Alias
UMLS CUI [1]
C1302584
dd/mm/yyyy
Treatment Second Primary Malignancy
Description

Treatment Second Primary Malignancy

Treatment given
Description

Treatment given

Data type

integer

Alias
UMLS CUI [1,1]
C0751623
UMLS CUI [1,2]
C0949634
*Specify
Description

Specify

Data type

text

Alias
UMLS CUI [1]
C1521902
Date of start treatment
Description

Date of start treatment

Data type

date

Measurement units
  • dd/mm/yyyy
Alias
UMLS CUI [1,1]
C0949634
UMLS CUI [1,2]
C0808070
dd/mm/yyyy
Response second primary malignancy
Description

Response

Data type

integer

Alias
UMLS CUI [1]
C1704632
*Specify
Description

Specify

Data type

text

Alias
UMLS CUI [1]
C1521902
Date response achieved
Description

Date response

Data type

date

Measurement units
  • dd/mm/yyyy
Alias
UMLS CUI [1,1]
C1704632
UMLS CUI [1,2]
C0011008
dd/mm/yyyy
Date last contact
Description

Date last contact

Data type

date

Measurement units
  • dd/mm/yyyy
Alias
UMLS CUI [1]
C0805839
dd/mm/yyyy
Survival status
Description

Survival status

Data type

integer

Alias
UMLS CUI [1]
C1148433
External/environmental exposures (Please provide any information about external / environmental exposures that might be risk factors for the reported SPM. If no information is available, fill out as ‘unknown’.)
Description

External/environmental exposures (Please provide any information about external / environmental exposures that might be risk factors for the reported SPM. If no information is available, fill out as ‘unknown’.)

Alias
UMLS CUI-1
C0014412
Tobacco
Description

Tobacco

Data type

integer

Alias
UMLS CUI [1]
C1519384
Alcohol
Description

Alcohol

Data type

integer

Alias
UMLS CUI [1]
C0001948
Exposure to chemicals
Description

Exposure to chemicals

Data type

integer

Alias
UMLS CUI [1]
C0220806
Occupation / hobbies
Description

Occupation / hobbies

Data type

integer

Alias
UMLS CUI [1]
C0028811
UMLS CUI [2]
C0019826
Sun exposure
Description

Sun exposure

Data type

integer

Alias
UMLS CUI [1]
C1456711
Previous chemo or radiation therapy
Description

Previous chemo or radiation therapy

Data type

integer

Alias
UMLS CUI [1]
C0949634
Other
Description

Other

Data type

integer

Alias
UMLS CUI [1,1]
C0014412
UMLS CUI [1,2]
C0205394
*Specify
Description

Specify

Data type

text

Alias
UMLS CUI [1]
C1521902
Report Information
Description

Report Information

Alias
UMLS CUI-1
C0684224
Type of report
Description

Type of Report Timepoint

Data type

integer

Alias
UMLS CUI [1,1]
C1276413
UMLS CUI [1,2]
C2348792
Date report
Description

Date report

Data type

date

Measurement units
  • dd/mm/yyyy
Alias
UMLS CUI [1]
C1302584
dd/mm/yyyy
Relevants Family's History (please provide relevant family’s medical history (such as known genetic mutations for breast cancer, prostate cancer, etc. or family member(s) – such as parents siblings, etc – with the same malignancy). Fill out ‘none’ if there is no relevant family medical history, or fill out ‘unknown’ if information is not available)
Description

Relevants Family's History (please provide relevant family’s medical history (such as known genetic mutations for breast cancer, prostate cancer, etc. or family member(s) – such as parents siblings, etc – with the same malignancy). Fill out ‘none’ if there is no relevant family medical history, or fill out ‘unknown’ if information is not available)

Relevant family's history
Description

Relevant familys history

Data type

integer

Alias
UMLS CUI [1]
C0241889
*Specify
Description

Specify

Data type

text

Alias
UMLS CUI [1]
C1521902
Comments
Description

Comments

Comments
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
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Similar models

Secondary Primary Malignancy Form (Secondary Primary Malignancy Form HOVON 132 AML/SAKK 30/13 EudraCT 2013-002843-26)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C0684224 (UMLS CUI-1)
Item
Type of report
integer
C1276413 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Date Report Timepoint
Code List
Type of report
CL Item
Initial report (1)
C0684224 (UMLS CUI-1)
CL Item
Follow up report (2)
C1704685 (UMLS CUI-1)
CL Item
Final report (3)
C0460114 (UMLS CUI-1)
Date report
Item
date
C1302584 (UMLS CUI [1])
Date of birth
Item
date
C0421451 (UMLS CUI [1])
Item Group
C0751623 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Item
Second primary malignancy
integer
C0751623 (UMLS CUI [1])
Second primary malignancy
Code List
Second primary malignancy
CL Item
acute leukemia* (1)
C0085669 (UMLS CUI-1)
CL Item
MDS* (2)
C3463824 (UMLS CUI-1)
CL Item
lymphoma* (3)
C0024299 (UMLS CUI-1)
CL Item
solid skin tumour* (4)
C0037286 (UMLS CUI-1)
CL Item
solid tumour (excl. skin)* (5)
C0280100 (UMLS CUI-1)
CL Item
other* (8)
C0205394 (UMLS CUI-1)
Specify
Item
*Specify
text
C1521902 (UMLS CUI [1])
Date of diagnosis
Item
Date of diagnosis
date
C2316983 (UMLS CUI [1,1])
C0751623 (UMLS CUI [1,2])
C1302659 (UMLS CUI [2])
Date clinical diagnosis
Item
date
C2316983 (UMLS CUI [1])
Item
Diagnosed during study phase
integer
C1276413 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Diagnosed during study pase
Code List
Diagnosed during study phase
CL Item
before start protocol treatment  (0)
C0040808 (UMLS CUI-1)
CL Item
induction cycle I  (1)
C3179010 (UMLS CUI-1)
CL Item
induction cycle II (2)
C3179010 (UMLS CUI-1)
CL Item
post induction cycle III  (3)
C3179010 (UMLS CUI-1)
CL Item
autoHSCT  (4)
C0194037 (UMLS CUI-1)
CL Item
alloHSCT  (5)
C1705576 (UMLS CUI-1)
CL Item
maintenance (1-6)*  (11-16)
C0481504 (UMLS CUI-1)
CL Item
follow up  (17)
C1522577 (UMLS CUI-1)
CL Item
other* (18)
C0205394 (UMLS CUI-1)
Cycle Number
Item
Cycle Number
integer
C2045829 (UMLS CUI [1])
Specify
Item
Specify
text
C1521902 (UMLS CUI [1])
Item Group
Pathology Result
Pathology Result
Item
Pathology Result (Please send in copy of report if available)
text
C0807321 (UMLS CUI [1])
Item Group
C0684224 (UMLS CUI-1)
Item
Type of Report
integer
C2348792 (UMLS CUI [1])
Date Report Timepoint
Code List
Type of Report
CL Item
Initial report (1)
C0684224 (UMLS CUI-1)
CL Item
Follow up report (2)
C1704685 (UMLS CUI-1)
CL Item
Final report (3)
C0460114 (UMLS CUI-1)
Date Report
Item
Date Report
date
C1302584 (UMLS CUI [1])
Item Group
Treatment Second Primary Malignancy
Item
Treatment given
integer
C0751623 (UMLS CUI [1,1])
C0949634 (UMLS CUI [1,2])
Treatment given
Code List
Treatment given
CL Item
no  (0)
C0445106 (UMLS CUI-1)
CL Item
chemotherapy only  (1)
C3665472 (UMLS CUI-1)
CL Item
surgery (2)
C0543467 (UMLS CUI-1)
CL Item
radiotherapy  (3)
C1522449 (UMLS CUI-1)
CL Item
monoclonal antibodies  (4)
C0003250 (UMLS CUI-1)
CL Item
combination*  (5)
C0009429 (UMLS CUI-1)
CL Item
other, please specify* (8)
C0205394 (UMLS CUI-1)
Specify
Item
*Specify
text
C1521902 (UMLS CUI [1])
Date of start treatment
Item
Date of start treatment
date
C0949634 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Response second primary malignancy
integer
C1704632 (UMLS CUI [1])
Response
Code List
Response second primary malignancy
CL Item
CR  (1)
C0677874 (UMLS CUI-1)
CL Item
PR  (2)
C1521726 (UMLS CUI-1)
CL Item
stable disease (3)
C0677946 (UMLS CUI-1)
CL Item
progressive disease (4)
C1335499 (UMLS CUI-1)
CL Item
other, please specify* (8)
C0205394 (UMLS CUI-1)
Specify
Item
*Specify
text
C1521902 (UMLS CUI [1])
Date response
Item
Date response achieved
date
C1704632 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Date last contact
Item
Date last contact
date
C0805839 (UMLS CUI [1])
Item
Survival status
integer
C1148433 (UMLS CUI [1])
Survival status
Code List
Survival status
CL Item
alive  (0)
C2584946 (UMLS CUI-1)
CL Item
dead (1)
C0011065 (UMLS CUI-1)
Item Group
External/environmental exposures (Please provide any information about external / environmental exposures that might be risk factors for the reported SPM. If no information is available, fill out as ‘unknown’.)
C0014412 (UMLS CUI-1)
Item
integer
C1519384 (UMLS CUI [1])
Tobacco
Code List
Tobacco
CL Item
no (0)
C1298908 (UMLS CUI-1)
CL Item
yes (1)
C1705108 (UMLS CUI-1)
CL Item
unknown (9)
C0439673 (UMLS CUI-1)
Item
integer
C0001948 (UMLS CUI [1])
Tobacco
Code List
Alcohol
CL Item
no (0)
C1298908 (UMLS CUI-1)
CL Item
yes (1)
C1705108 (UMLS CUI-1)
CL Item
unknown (9)
C0439673 (UMLS CUI-1)
Item
integer
C0220806 (UMLS CUI [1])
Tobacco
Code List
Exposure to chemicals
CL Item
no (0)
C1298908 (UMLS CUI-1)
CL Item
yes (1)
C1705108 (UMLS CUI-1)
CL Item
unknown (9)
C0439673 (UMLS CUI-1)
Item
integer
C0028811 (UMLS CUI [1])
C0019826 (UMLS CUI [2])
Tobacco
Code List
Occupation / hobbies
CL Item
no (0)
C1298908 (UMLS CUI-1)
CL Item
yes (1)
C1705108 (UMLS CUI-1)
CL Item
unknown (9)
C0439673 (UMLS CUI-1)
Item
integer
C1456711 (UMLS CUI [1])
Tobacco
Code List
Sun exposure
CL Item
no (0)
C1298908 (UMLS CUI-1)
CL Item
yes (1)
C1705108 (UMLS CUI-1)
CL Item
unknown (9)
C0439673 (UMLS CUI-1)
Item
Previous chemo or radiation therapy
integer
C0949634 (UMLS CUI [1])
Tobacco
Code List
Previous chemo or radiation therapy
CL Item
no (0)
C1298908 (UMLS CUI-1)
CL Item
yes (1)
C1705108 (UMLS CUI-1)
CL Item
unknown (9)
C0439673 (UMLS CUI-1)
Item
Other
integer
C0014412 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Tobacco
Code List
Other
CL Item
no (0)
C1298908 (UMLS CUI-1)
CL Item
yes (1)
C1705108 (UMLS CUI-1)
CL Item
unknown (9)
C0439673 (UMLS CUI-1)
Specify
Item
*Specify
text
C1521902 (UMLS CUI [1])
Item Group
Report Information
C0684224 (UMLS CUI-1)
Item
Type of report
integer
C1276413 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Date Report Timepoint
Code List
Type of report
CL Item
Initial report (1)
C0684224 (UMLS CUI-1)
CL Item
Follow up report (2)
C1704685 (UMLS CUI-1)
CL Item
Final report (3)
C0460114 (UMLS CUI-1)
Date report
Item
date
C1302584 (UMLS CUI [1])
Item Group
Relevants Family's History (please provide relevant family’s medical history (such as known genetic mutations for breast cancer, prostate cancer, etc. or family member(s) – such as parents siblings, etc – with the same malignancy). Fill out ‘none’ if there is no relevant family medical history, or fill out ‘unknown’ if information is not available)
Item
Relevant family's history
integer
C0241889 (UMLS CUI [1])
Tobacco
Code List
Relevant family's history
CL Item
no (0)
C1298908 (UMLS CUI-1)
CL Item
yes (1)
C1705108 (UMLS CUI-1)
CL Item
unknown (9)
C0439673 (UMLS CUI-1)
Specify
Item
*Specify
text
C1521902 (UMLS CUI [1])
Item Group
Comments
Item
text
C0947611 (UMLS CUI [1])
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