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ID
12349
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
Versions (3)
- 11/10/15 11/10/15 -
- 12/23/15 12/23/15 -
- 2/11/16 2/11/16 -
Uploaded on
November 10, 2015
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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
- StudyEvent: ODM
Similar models
Baseline Concomitant Diseases Form
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Disease nr
Item
integer
C0237753 (UMLS CUI [1])
Item
System Organ Class
integer
C2347091 (UMLS CUI [1,1])
C1140263 (UMLS CUI [1,2])
C1705313 (UMLS CUI [1,3])
C0027365 (UMLS CUI [1,4])
C1140263 (UMLS CUI [1,2])
C1705313 (UMLS CUI [1,3])
C0027365 (UMLS CUI [1,4])
CL Item
Blood and lymphatic system disorders (1)
CL Item
Cardiac disorders (2)
CL Item
Congenital, familial and genetic disorders (3)
CL Item
Ear and labyrinth disorders (4)
CL Item
Endocrine disorders (5)
CL Item
Eye disorders (6)
CL Item
Gastrointestinal disorders (7)
CL Item
General disorders and administration site conditions (8)
CL Item
Hepatobiliary disorders (9)
CL Item
Immune system disorders (10)
CL Item
Infections and infestations (11)
CL Item
Injury, poisoning and procedural complications (12)
CL Item
Investigations (13)
CL Item
Metabolism and nutrition disorders (14)
CL Item
Musculoskeletal and connective tissue disorders (15)
CL Item
Neoplasms benign, malignant and unspecified (incl cysts and polyps) (16)
CL Item
Nervous system disorders (17)
CL Item
Pregnancy, puerperium and perinatal conditions (18)
CL Item
Psychiatric disorders (19)
CL Item
Renal and urinary disorders (20)
CL Item
Reproductive system and breast disorders (21)
CL Item
Respiratory, thoracic and mediastinal disorders (22)
CL Item
Skin and subcutaneous tissue disorders (23)
CL Item
Social circumstances (24)
CL Item
Surgical and medical procedures (25)
CL Item
Vascular disorders (26)
Adverse Event Term
Item
Adverse Event Term (please use CTCAE Short Name plus Select term if applicable)
text
C2826934 (UMLS CUI [1])
Active at baseline
Item
boolean
C0243087 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C1442488 (UMLS CUI [1,3])
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])
C0441800 (UMLS CUI [1,2])