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ID
12350
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: Adverse Event Form
Stichworte
Versionen (3)
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Hochgeladen am
10. November 2015
DOI
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Creative Commons BY-NC 3.0
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Adverse Event Form HOVON 132 AML/SAKK 30/13 EudraCT 2013-002843-26
Ähnliche Modelle
Adverse Event Form
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
AE nr
Item
float
C0877248 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
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])
CTCAE grade
Item
CTCAE grade
float
C1516728 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,2])
SAE
Item
boolean
C1519255 (UMLS CUI [1])
CL Item
unrelated (0)
CL Item
unlikely (1)
CL Item
possibly (2)
CL Item
probably (3)
CL Item
definitely (4)
CL Item
unknown (5)
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])
C0808070 (UMLS CUI [1,2])
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])
C0806020 (UMLS CUI [1,2])