ID

12354

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: Pregnancy Form

Keywords

Versions (3)
  1. 11/10/15 11/10/15 -
  2. 12/28/15 12/28/15 -
  3. 2/11/16 2/11/16 -
Uploaded on

November 10, 2015

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Pregnancy Form HOVON 132 AML/SAKK 30/13 EudraCT 2013-002843-26

English

Pregnancy Form

1 forms  
  1. StudyEvent: ODM
    1. Pregnancy Form
Site Information
Description

Site Information

Alias
UMLS CUI-1
C0205145
Form completed by
Description

From completed by

Data type

text

Alias
UMLS CUI [1,1]
C0027361
UMLS CUI [1,2]
C0600091
Telephone Number
Description

TelephoneNumber

Data type

text

Alias
UMLS CUI [1,1]
C0237753
UMLS CUI [1,2]
C0039457
Date of initial report (within 24 hours)
Description

Pregnancy Report Date

Data type

date

Measurement units
  • dd/mm/yyyy
Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0011008
dd/mm/yyyy
Date of follow up report (in case of new data).
Description

Date follow up

Data type

date

Measurement units
  • dd/mm/yyyy
Alias
UMLS CUI [1,1]
C1522577
UMLS CUI [1,2]
C0011008
dd/mm/yyyy
Subject Information
Description

Subject Information

Alias
UMLS CUI-1
C2707520
Who has become pregnant?
Description

Who has become pregnant

Data type

integer

Alias
UMLS CUI [1]
C0032961
Date of Birth
Description

Date of Birth

Data type

date

Measurement units
  • dd/mm/yyyy
Alias
UMLS CUI [1,1]
C0033011
UMLS CUI [1,2]
C0421451
dd/mm/yyyy
Start date of last menses
Description

last menses

Data type

date

Measurement units
  • dd/mm/yyyy
Alias
UMLS CUI [1]
C0425932
dd/mm/yyyy
Date pregnancy confirmed
Description

Date pregnancy confirmed

Data type

date

Measurement units
  • dd/mm/yyyy
Alias
UMLS CUI [1]
C2584394
dd/mm/yyyy
Anticipated date of childbirth
Description

Anticipated date of childbirth

Data type

date

Measurement units
  • dd/mm/yyyy
Alias
UMLS CUI [1]
C2825543
dd/mm/yyyy
Trial Medication and Outcome
Description

Trial Medication and Outcome

Alias
UMLS CUI-1
C0040808
UMLS CUI-3
C0949634
UMLS CUI-5
C0032972
Period of treatment/last given treatment at time of conception
Description

Period of treatment/last given treatment at time of conception

Data type

integer

Alias
UMLS CUI [1]
C1302181
Pregnancy outcome
Description

Pregnancy outcome

Data type

integer

Alias
UMLS CUI [1]
C0032972
Specify
Description

Specify

Data type

text

Alias
UMLS CUI [1]
C1521902
Comments
Description

Comments

Back to the top of the page

Similar models

Pregnancy Form

1 forms
  1. StudyEvent: ODM
    1. Pregnancy Form
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C0205145 (UMLS CUI-1)
From completed by
Item
Form completed by
text
C0027361 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
TelephoneNumber
Item
Telephone Number
text
C0237753 (UMLS CUI [1,1])
C0039457 (UMLS CUI [1,2])
Pregnancy Report Date
Item
Date of initial report (within 24 hours)
date
C0032961 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Date follow up
Item
Date of follow up report (in case of new data).
date
C1522577 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
C2707520 (UMLS CUI-1)
Item
Who has become pregnant?
integer
C0032961 (UMLS CUI [1])
Who has become pregnant
Code List
Who has become pregnant?
CL Item
female patient  (1)
C0150905 (UMLS CUI-1)
CL Item
partner of male patient (2)
C3874858 (UMLS CUI-1)
Date of Birth
Item
date
C0033011 (UMLS CUI [1,1])
C0421451 (UMLS CUI [1,2])
last menses
Item
Start date of last menses
date
C0425932 (UMLS CUI [1])
Date pregnancy confirmed
Item
date
C2584394 (UMLS CUI [1])
Anticipated date of childbirth
Item
Anticipated date of childbirth
date
C2825543 (UMLS CUI [1])
Item Group
C0040808 (UMLS CUI-1)
C0949634 (UMLS CUI-3)
C0032972 (UMLS CUI-5)
Item
Period of treatment/last given treatment at time of conception
integer
C1302181 (UMLS CUI [1])
Period of treatment/last given treatment at time of conception
Code List
Period of treatment/last given treatment at time of conception
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)
Item
Pregnancy outcome
integer
C0032972 (UMLS CUI [1])
Pregnancy outcome
Code List
Pregnancy outcome
CL Item
not known at this date (please send in follow up report when new data are known) (1)
C0439673 (UMLS CUI-1)
CL Item
uneventful (normal/healthy baby) (2)
C0686744 (UMLS CUI-1)
CL Item
uneventful (normal/healthy baby) (2)
CL Item
induced abortion (3)
C1704300 (UMLS CUI-1)
CL Item
spontaneous abortion (4)
C0000786 (UMLS CUI-1)
CL Item
still birth (5)
C0595939 (UMLS CUI-1)
CL Item
neonatal death (6)
C0410916 (UMLS CUI-1)
CL Item
birth defects (7)
C0000768 (UMLS CUI-1)
CL Item
other* (8)
C0205394 (UMLS CUI-1)
Specify
Item
text
C1521902 (UMLS CUI [1])
Item Group
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial