ID

12213

Description

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

Keywords

  1. 10/18/15 10/18/15 -
Uploaded on

October 18, 2015

DOI

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License

Creative Commons BY 4.0

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Eligibility Head and Neck Squamous Cell Carcinoma NCT02143622

Eligibility Head and Neck Squamous Cell Carcinoma NCT02143622

Inclusion Criteria
Description

Inclusion Criteria

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

cetuximab; platinum

Data type

boolean

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

ecog performance status

Data type

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.
Description

Antineoplastic Drug/Agent Therapy

Data type

boolean

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

measurable disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
Exclusion Criteria
Description

Exclusion Criteria

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

treatment specific antibody

Data type

boolean

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

symptomatic; metastasis; brain

Data type

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.
Description

cancer treatment; systemic

Data type

boolean

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

allergy human immunoglobulin

Data type

boolean

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

Organ or Tissue Function

Data type

boolean

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

diarrhea

Data type

boolean

Alias
UMLS CUI [1]
C0011991

Similar models

Eligibility Head and Neck Squamous Cell Carcinoma NCT02143622

Name
Type
Description | Question | Decode (Coded Value)
Data type
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])

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