ID

12354

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: Pregnancy Form

Stichworte

Versionen (3)
  1. 10.11.15 10.11.15 -
  2. 28.12.15 28.12.15 -
  3. 11.02.16 11.02.16 -
Hochgeladen am

10. November 2015

DOI

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

Englisch

Pregnancy Form

1 Formulare  
  1. StudyEvent: ODM
    1. Pregnancy Form
Site Information
Beschreibung

Site Information

Alias
UMLS CUI-1
C0205145
Form completed by
Beschreibung

From completed by

Datentyp

text

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

TelephoneNumber

Datentyp

text

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

Pregnancy Report Date

Datentyp

date

Maßeinheiten
  • 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).
Beschreibung

Date follow up

Datentyp

date

Maßeinheiten
  • dd/mm/yyyy
Alias
UMLS CUI [1,1]
C1522577
UMLS CUI [1,2]
C0011008
dd/mm/yyyy
Subject Information
Beschreibung

Subject Information

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

Who has become pregnant

Datentyp

integer

Alias
UMLS CUI [1]
C0032961
Date of Birth
Beschreibung

Date of Birth

Datentyp

date

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

last menses

Datentyp

date

Maßeinheiten
  • dd/mm/yyyy
Alias
UMLS CUI [1]
C0425932
dd/mm/yyyy
Date pregnancy confirmed
Beschreibung

Date pregnancy confirmed

Datentyp

date

Maßeinheiten
  • dd/mm/yyyy
Alias
UMLS CUI [1]
C2584394
dd/mm/yyyy
Anticipated date of childbirth
Beschreibung

Anticipated date of childbirth

Datentyp

date

Maßeinheiten
  • dd/mm/yyyy
Alias
UMLS CUI [1]
C2825543
dd/mm/yyyy
Trial Medication and Outcome
Beschreibung

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
Beschreibung

Period of treatment/last given treatment at time of conception

Datentyp

integer

Alias
UMLS CUI [1]
C1302181
Pregnancy outcome
Beschreibung

Pregnancy outcome

Datentyp

integer

Alias
UMLS CUI [1]
C0032972
Specify
Beschreibung

Specify

Datentyp

text

Alias
UMLS CUI [1]
C1521902
Comments
Beschreibung

Comments

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Ähnliche Modelle

Pregnancy Form

1 Formulare
  1. StudyEvent: ODM
    1. Pregnancy Form
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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
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