ID

12213

Descrição

Study of Efficacy and Safety of LJM716 and Cetuximab in Head and Neck Squamous Cell Carcinoma Patients; ODM derived from: https://clinicaltrials.gov/show/NCT02143622

Link

https://clinicaltrials.gov/show/NCT02143622

Palavras-chave

  1. 18/10/2015 18/10/2015 -
Transferido a

18 de outubro de 2015

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.

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 Head and Neck Squamous Cell Carcinoma NCT02143622

Eligibility Head and Neck Squamous Cell Carcinoma NCT02143622

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
most recent regimen contains both platinum and cetuximab (phase ii, group b).
Descrição

cetuximab; platinum

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0995188
UMLS CUI [2]
C0032207
ecog performance status (ps) ≤ 2.
Descrição

ecog performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
recovery from all aes of previous anti-cancer therapies, to baseline or to ctcae grade ≤ 1, except for alopecia.
Descrição

Antineoplastic Drug/Agent Therapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2346834
measurable disease as determined by recist v1.1.
Descrição

measurable disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1513041
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous anti-her3 antibody treatment.
Descrição

treatment specific antibody

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0443640
symptomatic brain metastasis.
Descrição

symptomatic; metastasis; brain

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0231220
UMLS CUI [2]
C0027627
UMLS CUI [3]
C0006104
prior systemic anti-cancer treatment, within a period of time that is shorter than the cycle length used for that treatment prior to starting study treatment.
Descrição

cancer treatment; systemic

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2]
C0205373
prior anaphylactic or other severe infusion reaction to human immunoglobulin or antibody formulations.
Descrição

allergy human immunoglobulin

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C3537193
inadequate end organ function.
Descrição

Organ or Tissue Function

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1254358
ongoing diarrhea ctcae grade ≥ 2. other protocol-defined inclusion/exclusion criteria may apply
Descrição

diarrhea

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011991

Similar models

Eligibility Head and Neck Squamous Cell Carcinoma NCT02143622

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
cetuximab; platinum
Item
most recent regimen contains both platinum and cetuximab (phase ii, group b).
boolean
C0995188 (UMLS CUI [1])
C0032207 (UMLS CUI [2])
ecog performance status
Item
ecog performance status (ps) ≤ 2.
boolean
C1520224 (UMLS CUI [1])
Antineoplastic Drug/Agent Therapy
Item
recovery from all aes of previous anti-cancer therapies, to baseline or to ctcae grade ≤ 1, except for alopecia.
boolean
C2346834 (UMLS CUI [1])
measurable disease
Item
measurable disease as determined by recist v1.1.
boolean
C1513041 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
treatment specific antibody
Item
previous anti-her3 antibody treatment.
boolean
C0087111 (UMLS CUI [1,1])
C0443640 (UMLS CUI [1,2])
symptomatic; metastasis; brain
Item
symptomatic brain metastasis.
boolean
C0231220 (UMLS CUI [1])
C0027627 (UMLS CUI [2])
C0006104 (UMLS CUI [3])
cancer treatment; systemic
Item
prior systemic anti-cancer treatment, within a period of time that is shorter than the cycle length used for that treatment prior to starting study treatment.
boolean
C0920425 (UMLS CUI [1])
C0205373 (UMLS CUI [2])
allergy human immunoglobulin
Item
prior anaphylactic or other severe infusion reaction to human immunoglobulin or antibody formulations.
boolean
C0020517 (UMLS CUI [1,1])
C3537193 (UMLS CUI [1,2])
Organ or Tissue Function
Item
inadequate end organ function.
boolean
C1254358 (UMLS CUI [1])
diarrhea
Item
ongoing diarrhea ctcae grade ≥ 2. other protocol-defined inclusion/exclusion criteria may apply
boolean
C0011991 (UMLS CUI [1])

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

Campos marcados com * são obrigatórios.

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