ID

13480

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: Baseline Concomitant Diseases Form

Keywords

  1. 11/10/15 11/10/15 -
  2. 12/23/15 12/23/15 -
  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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Baseline Concomitant Diseases Form HOVON 132 AML/SAKK 30/13 EudraCT 2013-002843-26

Baseline Concomitant Diseases Form

Baseline Concomitant Diseases
Description

Baseline Concomitant Diseases

Alias
UMLS CUI-1
C0009488
Disease nr
Description

Disease nr

Data type

integer

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0750480
System Organ Class
Description

System Organ Class

Data type

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

Data type

text

Alias
UMLS CUI [1,1]
C2826934
UMLS CUI [1,2]
C1516728
Active at baseline
Description

Active at baseline

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205177
UMLS CUI [1,3]
C1442488
CTCAE grade
Description

CTCAE grade

Data type

float

Alias
UMLS CUI [1,1]
C1516728
UMLS CUI [1,2]
C0441800

Similar models

Baseline Concomitant Diseases Form

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Baseline Concomitant Diseases
C0009488 (UMLS CUI-1)
Disease nr
Item
Disease nr
integer
C0009488 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Item
System Organ Class
integer
C2347091 (UMLS CUI [1,1])
C0460002 (UMLS CUI [1,2])
Code List
System Organ Class
CL Item
Blood and lymphatic system disorders  (1)
C0851353 (UMLS CUI-1)
CL Item
Heart failure (2)
C0018801 (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)
C0042373 (UMLS CUI-1)
Adverse event term
Item
Adverse event term (please use CTCAE short name plus select term if applicable)
text
C2826934 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Active at baseline
Item
boolean
C0009488 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C1442488 (UMLS CUI [1,3])
CTCAE grade
Item
CTCAE grade
float
C1516728 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])

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