ID

15504

Descrição

An Open-Label, Phase 1b Study of ACP-196 With and Without Dexamethasone in Subjects With Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT02211014

Link

https://clinicaltrials.gov/show/NCT02211014

Palavras-chave

Versões (1)
  1. 01/06/2016 01/06/2016 -
Transferido a

1 de junho de 2016

DOI

Para um pedido faça login.

Licença

Creative Commons BY 4.0
Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Voltar para os comentários do modelo
Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

Eligibility Multiple Myeloma (MM) NCT02211014

Inglês

Eligibility Multiple Myeloma (MM) NCT02211014

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
men and women ≥ 18 years of age.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
a confirmed diagnosis of mm, which has relapsed after, or been refractory to ≥ 1 prior therapy for mm, and is progressing at the time of study entry.
Descrição

Multiple Myeloma | Recurrent disease | Refractory Prior Therapy | Disease Progression

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0026764
UMLS CUI [2]
C0277556
UMLS CUI [3,1]
C0205269
UMLS CUI [3,2]
C1514463
UMLS CUI [4]
C0242656
eastern cooperative oncology group (ecog) performance status of ≤ 2.
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
agreement to use contraception during the study and for 30 days after the last dose of study drugs if sexually active and able to bear or beget children.
Descrição

Sexually active | Females & males of reproductive potential | Agreement Contraceptive methods

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0241028
UMLS CUI [2]
C4034483
UMLS CUI [3,1]
C0680240
UMLS CUI [3,2]
C0700589
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
a life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of acp-196, or put the study outcomes at undue risk
Descrição

Life threatening illness | Medical condition | Organ dysfunction | Patient safety At risk | Interferes with absorption ACP-196 | Interferes with metabolic aspects ACP-196 | Risk research results

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3846017
UMLS CUI [2]
C1699700
UMLS CUI [3]
C0349410
UMLS CUI [4,1]
C1113679
UMLS CUI [4,2]
C1444641
UMLS CUI [5,1]
C0521102
UMLS CUI [5,2]
C0678745
UMLS CUI [5,3]
C3827171
UMLS CUI [6,1]
C0521102
UMLS CUI [6,2]
C0025520
UMLS CUI [6,3]
C3827171
UMLS CUI [7,1]
C0035647
UMLS CUI [7,2]
C0683954
significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 or 4 cardiac disease as defined by the new york heart association functional classification
Descrição

Cardiovascular Diseases | Cardiac Arrhythmia Uncontrolled | ARRHYTHMIA SYMPTOMATIC | Congestive heart failure | Myocardial Infarction | New York Heart Association Classification

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2,1]
C0003811
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C0741212
UMLS CUI [4]
C0018802
UMLS CUI [5]
C0027051
UMLS CUI [6]
C1275491
malabsorption syndrome, disease significantly affecting gastrointestinal function, gastric bypass, resection of the stomach or small bowel, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
Descrição

Malabsorption Syndrome | Disease Affecting gastrointestinal function | Gastric Bypass | Excision Stomach | Small intestine excision | Inflammatory Bowel Diseases Symptomatic | Partial bowel obstruction | Intestinal Obstruction Complete

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0024523
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0516983
UMLS CUI [3]
C0017125
UMLS CUI [4,1]
C0728940
UMLS CUI [4,2]
C0038351
UMLS CUI [5]
C0192601
UMLS CUI [6,1]
C0021390
UMLS CUI [6,2]
C0231220
UMLS CUI [7]
C1328480
UMLS CUI [8,1]
C0021843
UMLS CUI [8,2]
C0205197
breast feeding or pregnant
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Voltar ao início da página

Similar models

Eligibility Multiple Myeloma (MM) NCT02211014

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
men and women ≥ 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Multiple Myeloma | Recurrent disease | Refractory Prior Therapy | Disease Progression
Item
a confirmed diagnosis of mm, which has relapsed after, or been refractory to ≥ 1 prior therapy for mm, and is progressing at the time of study entry.
boolean
C0026764 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
C0205269 (UMLS CUI [3,1])
C1514463 (UMLS CUI [3,2])
C0242656 (UMLS CUI [4])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of ≤ 2.
boolean
C1520224 (UMLS CUI [1])
Sexually active | Females & males of reproductive potential | Agreement Contraceptive methods
Item
agreement to use contraception during the study and for 30 days after the last dose of study drugs if sexually active and able to bear or beget children.
boolean
C0241028 (UMLS CUI [1])
C4034483 (UMLS CUI [2])
C0680240 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Life threatening illness | Medical condition | Organ dysfunction | Patient safety At risk | Interferes with absorption ACP-196 | Interferes with metabolic aspects ACP-196 | Risk research results
Item
a life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of acp-196, or put the study outcomes at undue risk
boolean
C3846017 (UMLS CUI [1])
C1699700 (UMLS CUI [2])
C0349410 (UMLS CUI [3])
C1113679 (UMLS CUI [4,1])
C1444641 (UMLS CUI [4,2])
C0521102 (UMLS CUI [5,1])
C0678745 (UMLS CUI [5,2])
C3827171 (UMLS CUI [5,3])
C0521102 (UMLS CUI [6,1])
C0025520 (UMLS CUI [6,2])
C3827171 (UMLS CUI [6,3])
C0035647 (UMLS CUI [7,1])
C0683954 (UMLS CUI [7,2])
Cardiovascular Diseases | Cardiac Arrhythmia Uncontrolled | ARRHYTHMIA SYMPTOMATIC | Congestive heart failure | Myocardial Infarction | New York Heart Association Classification
Item
significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 or 4 cardiac disease as defined by the new york heart association functional classification
boolean
C0007222 (UMLS CUI [1])
C0003811 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0741212 (UMLS CUI [3])
C0018802 (UMLS CUI [4])
C0027051 (UMLS CUI [5])
C1275491 (UMLS CUI [6])
Malabsorption Syndrome | Disease Affecting gastrointestinal function | Gastric Bypass | Excision Stomach | Small intestine excision | Inflammatory Bowel Diseases Symptomatic | Partial bowel obstruction | Intestinal Obstruction Complete
Item
malabsorption syndrome, disease significantly affecting gastrointestinal function, gastric bypass, resection of the stomach or small bowel, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
boolean
C0024523 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0516983 (UMLS CUI [2,3])
C0017125 (UMLS CUI [3])
C0728940 (UMLS CUI [4,1])
C0038351 (UMLS CUI [4,2])
C0192601 (UMLS CUI [5])
C0021390 (UMLS CUI [6,1])
C0231220 (UMLS CUI [6,2])
C1328480 (UMLS CUI [7])
C0021843 (UMLS CUI [8,1])
C0205197 (UMLS CUI [8,2])
Pregnancy | Breast Feeding
Item
breast feeding or pregnant
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Voltar ao início da página 

Contacto

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Ajuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial