ID

12213

Beschrijving

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

Trefwoorden

  1. 18-10-15 18-10-15 -
Geüploaded op

18 oktober 2015

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0

Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Head and Neck Squamous Cell Carcinoma NCT02143622

Eligibility Head and Neck Squamous Cell Carcinoma NCT02143622

Inclusion Criteria
Beschrijving

Inclusion Criteria

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

cetuximab; platinum

Datatype

boolean

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

ecog performance status

Datatype

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.
Beschrijving

Antineoplastic Drug/Agent Therapy

Datatype

boolean

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

measurable disease

Datatype

boolean

Alias
UMLS CUI [1]
C1513041
Exclusion Criteria
Beschrijving

Exclusion Criteria

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

treatment specific antibody

Datatype

boolean

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

symptomatic; metastasis; brain

Datatype

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.
Beschrijving

cancer treatment; systemic

Datatype

boolean

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

allergy human immunoglobulin

Datatype

boolean

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

Organ or Tissue Function

Datatype

boolean

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

diarrhea

Datatype

boolean

Alias
UMLS CUI [1]
C0011991

Similar models

Eligibility Head and Neck Squamous Cell Carcinoma NCT02143622

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

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