ID

13484

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

February 11, 2016

DOI

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License

Creative Commons BY-NC 3.0
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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
C2825164
Form completed by
Description

From completed by

Data type

text

Alias
UMLS CUI [1]
C0557514
Telephone Number
Description

TelephoneNumber

Data type

text

Alias
UMLS CUI [1]
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]
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
C0013227
UMLS CUI-2
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 [1,1]
C1276413
UMLS CUI [1,2]
C2348792
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

Alias
UMLS CUI-1
C0947611
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Similar models

Pregnancy Form

1 forms
  1. StudyEvent: ODM
    1. Pregnancy Form
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Site Information
C2825164 (UMLS CUI-1)
From completed by
Item
Form completed by
text
C0557514 (UMLS CUI [1])
TelephoneNumber
Item
Telephone Number
text
C0039457 (UMLS CUI [1])
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
Subject Information
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 of Birth
date
C0421451 (UMLS CUI [1])
last menses
Item
Start date of last menses
date
C0425932 (UMLS CUI [1])
Date pregnancy confirmed
Item
Date pregnancy confirmed
date
C2584394 (UMLS CUI [1])
Anticipated date of childbirth
Item
Anticipated date of childbirth
date
C2825543 (UMLS CUI [1])
Item Group
Trial Medication and Outcome
C0013227 (UMLS CUI-1)
C0032972 (UMLS CUI-2)
Item
Period of treatment/last given treatment at time of conception
integer
C1276413 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
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)
C0087111 (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
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)
CL Item
uneventful (normal/healthy baby) (2)
C0686744 (UMLS CUI-1)
Specify
Item
Specify
text
C1521902 (UMLS CUI [1])
Item Group
Comments
C0947611 (UMLS CUI-1)
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