Informações:
Falhas:
ID
13481
Descrição
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
Palavras-chave
Versões (3)
- 10/11/2015 10/11/2015 -
- 23/12/2015 23/12/2015 -
- 11/02/2016 11/02/2016 -
Transferido a
11 de fevereiro de 2016
DOI
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Licença
Creative Commons BY-NC 3.0
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Adverse Event Form HOVON 132 AML/SAKK 30/13 EudraCT 2013-002843-26
Similar models
Adverse Event Form
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
AE nr
Item
AE nr
float
C0877248 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,2])
Item
System Organ Class
integer
C2347091 (UMLS CUI [1,1])
C0460002 (UMLS CUI [1,2])
C0460002 (UMLS CUI [1,2])
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])
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])
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)
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])