ID

13481

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: Adverse Event Form

Mots-clés

Versions (3)
  1. 10/11/2015 10/11/2015 -
  2. 23/12/2015 23/12/2015 -
  3. 11/02/2016 11/02/2016 -
Téléchargé le

11 février 2016

DOI

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Licence

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

Anglais

Adverse Event Form

1 Formulaires  
  1. StudyEvent: ODM
    1. Adverse Event Form
Adverse Event
Description

Adverse Event

Alias
UMLS CUI-1
C0877248
AE nr
Description

AE nr

Type de données

float

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750480
System Organ Class
Description

System Organ Class

Type de données

integer

Alias
UMLS CUI [1,1]
C2347091
UMLS CUI [1,2]
C0460002
Adverse Event Term (please use CTCAE Short Name plus Select term if applicable)
Description

Adverse Event Term

Type de données

text

Alias
UMLS CUI [1]
C2826934
CTCAE grade
Description

CTCAE grade

Type de données

float

Alias
UMLS CUI [1,1]
C1516728
UMLS CUI [1,2]
C0441800
Serious adverse event
Description

SAE

Type de données

boolean

Alias
UMLS CUI [1]
C1519255
Relationship to protocol treatment
Description

Relationship to protocol treatment

Type de données

integer

Alias
UMLS CUI [1]
C0041755
Related to
Description

Related to

Type de données

integer

Alias
UMLS CUI [1,1]
C0041755
UMLS CUI [1,2]
C0013227
Treatment changed
Description

Treatment changed

Type de données

boolean

Alias
UMLS CUI [1]
C1299575
AE date start
Description

AE date start

Type de données

date

Unités de mesure
  • dd/mm/yyyy
Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0808070
dd/mm/yyyy
AE Outcome
Description

AE Outcome

Type de données

integer

Alias
UMLS CUI [1]
C1705586
Date end
Description

AE Date end

Type de données

date

Unités de mesure
  • dd/mm/yyyy
Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0806020
dd/mm/yyyy
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Similar models

Adverse Event Form

1 Formulaires
  1. StudyEvent: ODM
    1. Adverse Event Form
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Adverse Event
C0877248 (UMLS CUI-1)
AE nr
Item
AE nr
float
C0877248 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Item
System Organ Class
integer
C2347091 (UMLS CUI [1,1])
C0460002 (UMLS CUI [1,2])
System Organ Class
Code List
System Organ Class
CL Item
Blood and lymphatic system disorders  (1)
C0851353 (UMLS CUI-1)
CL Item
Cardiac disorders  (2)
C0178273 (UMLS CUI-1)
CL Item
Congenital, familial and genetic disorders  (3)
C0851352 (UMLS CUI-1)
CL Item
Ear and labyrinth disorders  (4)
C0851354 (UMLS CUI-1)
CL Item
Endocrine disorders  (5)
C0014130 (UMLS CUI-1)
CL Item
Eye disorders  (6)
C0015397 (UMLS CUI-1)
CL Item
Gastrointestinal disorders  (7)
C0017178 (UMLS CUI-1)
CL Item
General disorders and administration site conditions  (8)
C0851362 (UMLS CUI-1)
CL Item
Hepatobiliary disorders  (9)
C0267792 (UMLS CUI-1)
CL Item
Immune system disorders  (10)
C1334156 (UMLS CUI-1)
CL Item
Infections and infestations  (11)
C0851565 (UMLS CUI-1)
CL Item
Injury, poisoning and procedural complications  (12)
C0947733 (UMLS CUI-1)
CL Item
Investigations  (13)
C0841577 (UMLS CUI-1)
CL Item
Metabolism and nutrition disorders  (14)
C0851358 (UMLS CUI-1)
CL Item
Musculoskeletal and connective tissue disorders  (15)
C0263660 (UMLS CUI-1)
CL Item
Neoplasms benign, malignant and unspecified (incl cysts and polyps)  (16)
C0027651 (UMLS CUI-1)
CL Item
Nervous system disorders  (17)
C0810273 (UMLS CUI-1)
CL Item
Pregnancy, puerperium and perinatal conditions  (18)
C0851363 (UMLS CUI-1)
CL Item
Psychiatric disorders  (19)
C0004936 (UMLS CUI-1)
CL Item
Renal and urinary disorders  (20)
C0042075 (UMLS CUI-1)
CL Item
Reproductive system and breast disorders  (21)
C0851366 (UMLS CUI-1)
CL Item
Respiratory, thoracic and mediastinal disorders  (22)
C0851355 (UMLS CUI-1)
CL Item
Skin and subcutaneous tissue disorders  (23)
C0178301 (UMLS CUI-1)
CL Item
Social circumstances  (24)
C0851364 (UMLS CUI-1)
CL Item
Surgical and medical procedures  (25)
C1948041 (UMLS CUI-1)
CL Item
Vascular disorders (26)
C0400883 (UMLS CUI-1)
Adverse Event Term
Item
Adverse Event Term (please use CTCAE Short Name plus Select term if applicable)
text
C2826934 (UMLS CUI [1])
CTCAE grade
Item
CTCAE grade
float
C1516728 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
SAE
Item
Serious adverse event
boolean
C1519255 (UMLS CUI [1])
Item
Relationship to protocol treatment
integer
C0041755 (UMLS CUI [1])
Relationship to protocol treatment
Code List
Relationship to protocol treatment
CL Item
unrelated  (0)
C0445356 (UMLS CUI-1)
CL Item
unlikely  (1)
C0750558 (UMLS CUI-1)
CL Item
possibly  (2)
C0332149 (UMLS CUI-1)
CL Item
probably  (3)
C0750492 (UMLS CUI-1)
CL Item
definitely  (4)
C1704787 (UMLS CUI-1)
CL Item
unknown (5)
C0439673 (UMLS CUI-1)
Item
Related to
integer
C0041755 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Related to
Code List
Related to
CL Item
Lenalidomide  (1)
C1144149 (UMLS CUI-1)
CL Item
other trial medication/SCT  (2)
CL Item
Lenalidomide + other trial medication/SCT  (3)
CL Item
unknown (9)
C0439673 (UMLS CUI-1)
Treatment changed
Item
Treatment changed
boolean
C1299575 (UMLS CUI [1])
AE date start
Item
AE date start
date
C0877248 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
AE Outcome
integer
C1705586 (UMLS CUI [1])
AE Outcome
Code List
AE Outcome
CL Item
resolved completely  (1)
M (UMLS CUI-1)
CL Item
resolved to baseline  (2)
M (UMLS CUI-1)
CL Item
resolved with sequelae  (3)
M (UMLS CUI-1)
CL Item
ongoing (pending)  (4)
M (UMLS CUI-1)
CL Item
ongoing with higher CTCAE grade  (5)
M (UMLS CUI-1)
CL Item
ongoing (closed)  (6)
M (UMLS CUI-1)
CL Item
death (7)
M (UMLS CUI-1)
AE Date end
Item
Date end
date
C0877248 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
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