ID

12386

Beschreibung

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

Stichworte

Versionen (2)
  1. 11.11.15 11.11.15 -
  2. 18.12.15 18.12.15 -
Hochgeladen am

11. November 2015

DOI

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

Englisch

Secondary Primary Malignancy Form

1 Formulare  
Report Information
Beschreibung

Report Information

Alias
UMLS CUI-1
C0684224
Type of report
Beschreibung

Type of Report Timepoint

Datentyp

integer

Alias
UMLS CUI [1]
C2348792
Date report
Beschreibung

Date report

Datentyp

date

Maßeinheiten
  • dd/mm/yyyy
Alias
UMLS CUI [1]
C1302584
dd/mm/yyyy
Date of birth
Beschreibung

Date of birth

Datentyp

date

Maßeinheiten
  • dd/mm/yyyy
Alias
UMLS CUI [1]
C0421451
dd/mm/yyyy
Second Primary Malignancy Information
Beschreibung

Second Primary Malignancy Information

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

Second primary malignancy

Datentyp

integer

Alias
UMLS CUI [1]
C0751623
*Specify
Beschreibung

Specify

Datentyp

text

Alias
UMLS CUI [1]
C1521902
Date of diagnosis
Beschreibung

Date of diagnosis

Datentyp

date

Maßeinheiten
  • dd/mm/yyyy
Alias
UMLS CUI [1,1]
C2316983
UMLS CUI [1,2]
C0751623
UMLS CUI [2]
C1302659
dd/mm/yyyy
Date clinical diagnosis
Beschreibung

Date clinical diagnosis

Datentyp

date

Maßeinheiten
  • dd/mm/yyyy
Alias
UMLS CUI [1]
C2316983
dd/mm/yyyy
Diagnosed during study pase
Beschreibung

Diagnosed during study pase

Datentyp

integer

Alias
UMLS CUI [1]
C1302181
Cycle Number
Beschreibung

Cycle Number

Datentyp

integer

Alias
UMLS CUI [1]
C2045829
Specify
Beschreibung

Specify

Datentyp

text

Alias
UMLS CUI [1]
C1521902
Pathology Result
Beschreibung

Pathology Result

Alias
UMLS CUI-1
C0807321
Pathology Result (Please send in copy of report if available)
Beschreibung

Pathology Result

Datentyp

text

Alias
UMLS CUI [1]
C0807321
Report Information
Beschreibung

Report Information

Alias
UMLS CUI-1
C0684224
Type of Report
Beschreibung

Type of Report Timepoint

Datentyp

integer

Alias
UMLS CUI [1]
C2348792
Date Report
Beschreibung

Date Report

Datentyp

date

Maßeinheiten
  • dd/mm/yyyy
Alias
UMLS CUI [1]
C1302584
dd/mm/yyyy
Treatment Second Primary Malignancy
Beschreibung

Treatment Second Primary Malignancy

Alias
UMLS CUI-1
C0751623
UMLS CUI-2
C0087111
Treatment given
Beschreibung

Treatment given

Datentyp

integer

Alias
UMLS CUI [1,1]
C0751623
UMLS CUI [1,2]
C0087111
*Specify
Beschreibung

Specify

Datentyp

text

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

Date of start treatment

Datentyp

date

Maßeinheiten
  • dd/mm/yyyy
Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0808070
dd/mm/yyyy
Response second primary malignancy
Beschreibung

Response

Datentyp

integer

Alias
UMLS CUI [1]
C1704632
*Specify
Beschreibung

Specify

Datentyp

text

Alias
UMLS CUI [1]
C1521902
Date response achieved
Beschreibung

Date response

Datentyp

date

Maßeinheiten
  • dd/mm/yyyy
Alias
UMLS CUI [1]
C1704632
dd/mm/yyyy
Date last contact
Beschreibung

Date last contact

Datentyp

date

Maßeinheiten
  • dd/mm/yyyy
Alias
UMLS CUI [1]
C0805839
dd/mm/yyyy
Survival status
Beschreibung

Survival status

Datentyp

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’.)
Beschreibung

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
C2220266
Tobacco
Beschreibung

Tobacco

Datentyp

integer

Alias
UMLS CUI [1]
C1519384
Alcohol
Beschreibung

Alcohol

Datentyp

integer

Alias
UMLS CUI [1]
C0001948
Exposure to chemicals
Beschreibung

Exposure to chemicals

Datentyp

integer

Alias
UMLS CUI [1]
C0220806
Occupation / hobbies
Beschreibung

Occupation / hobbies

Datentyp

integer

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

Sun exposure

Datentyp

integer

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

Previous chemo or radiation therapy

Datentyp

integer

Alias
UMLS CUI [1]
C3665472
UMLS CUI [2]
C1384668
Other
Beschreibung

Other

Datentyp

integer

Alias
UMLS CUI [1,1]
C2220266
UMLS CUI [1,2]
C0205394
*Specify
Beschreibung

Specify

Datentyp

text

Alias
UMLS CUI [1]
C1521902
Report Information
Beschreibung

Report Information

Alias
UMLS CUI-1
C0684224
Type of report
Beschreibung

Type of Report Timepoint

Datentyp

integer

Alias
UMLS CUI [1]
C2348792
Date report
Beschreibung

Date report

Datentyp

date

Maßeinheiten
  • 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)
Beschreibung

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)

Alias
UMLS CUI-1
C0241889
Relevant family's history
Beschreibung

Relevant familys history

Datentyp

integer

Alias
UMLS CUI [1]
C0241889
*Specify
Beschreibung

Specify

Datentyp

text

Alias
UMLS CUI [1]
C1521902
Comments
Beschreibung

Comments

Comments
Beschreibung

Comments

Datentyp

text

Alias
UMLS CUI [1]
C0947611
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Ähnliche Modelle

Secondary Primary Malignancy Form

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
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)
C0205435 (UMLS CUI-2)
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 pase
integer
C1302181 (UMLS CUI [1])
Diagnosed during study pase
Code List
Diagnosed during study pase
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
integer
C2045829 (UMLS CUI [1])
Specify
Item
text
C1521902 (UMLS CUI [1])
Item Group
C0807321 (UMLS CUI-1)
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)
C0205435 (UMLS CUI-2)
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
C0751623 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
Item
Treatment given
integer
C0751623 (UMLS CUI [1,1])
C0087111 (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
C0087111 (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])
Date last contact
Item
date
C0805839 (UMLS CUI [1])
Item
integer
C1148433 (UMLS CUI [1])
Survival status
Code List
Survival status
CL Item
alive  (0)
CL Item
dead (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’.)
C2220266 (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
integer
C3665472 (UMLS CUI [1])
C1384668 (UMLS CUI [2])
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
integer
C2220266 (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
C2348792 (UMLS CUI [1])
Date Report Timepoint
Code List
Type of report
CL Item
Initial report (1)
C0684224 (UMLS CUI-1)
C0205435 (UMLS CUI-2)
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)
C0241889 (UMLS CUI-1)
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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