ID

31640

Beskrivning

A Study of the Safety and Efficacy of Single-agent Carlumab (an Anti-Chemokine Ligand 2 [CCL2]) in Participants With Metastatic Castrate-Resistant Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00992186

Länk

https://clinicaltrials.gov/show/NCT00992186

Nyckelord

Versioner (1)
  1. 2018-09-15 2018-09-15 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

15 september 2018

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Prostate Cancer NCT00992186

Engelsk

Eligibility Prostate Cancer NCT00992186

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histological documentation of adenocarcinoma of the prostate
Beskrivning

Adenocarcinoma of prostate

Datatyp

boolean

Alias
UMLS CUI [1]
C0007112
received at least 1 but no more than 2 prior docetaxel-based chemotherapy regimens and had disease progression following the last therapy
Beskrivning

Docetaxel Prior Chemotherapy Quantity | Disease Progression Post Therapeutic procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0246415
UMLS CUI [1,2]
C1514457
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0242656
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C0087111
serum prostate specific antigen (psa) greater than or equal to 5.0 nanogram/milliliter (ng/ml) within 4 weeks prior to the first dose of study agent
Beskrivning

Prostate specific antigen measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0201544
orchiectomy (surgery to remove one or both testicles) or testosterone less than 50 nanogram/deciliter by means of pharmacological/chemical castration within 4 weeks prior to the first dose of study agent
Beskrivning

Orchiectomy | Testosterone measurement | Medical Castration | Chemical male castration

Datatyp

boolean

Alias
UMLS CUI [1]
C0029189
UMLS CUI [2]
C0523912
UMLS CUI [3]
C1513054
UMLS CUI [4]
C0455189
at least 6 weeks from prior docetaxel chemotherapy regimen to first dose of study agent
Beskrivning

Docetaxel Prior Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0246415
UMLS CUI [1,2]
C1514457
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
experience a hormonal treatment withdrawal response (including a lowering of psa that was previously rising or symptomatic improvement)
Beskrivning

Hormone Therapy Withdrawal Response | Prostatic specific antigen decreased | Raised prostate specific antigen Previous | Improvement Symptomatic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C2349954
UMLS CUI [1,3]
C1704632
UMLS CUI [2]
C0178414
UMLS CUI [3,1]
C0178415
UMLS CUI [3,2]
C0205156
UMLS CUI [4,1]
C2986411
UMLS CUI [4,2]
C0231220
known or symptomatic central nervous system metastases
Beskrivning

CNS metastases | CNS metastases Symptomatic

Datatyp

boolean

Alias
UMLS CUI [1]
C0686377
UMLS CUI [2,1]
C0686377
UMLS CUI [2,2]
C0231220
residual toxicities resulting from previous therapy that are grade 2 or more (except for alopecia)
Beskrivning

Toxicity Due to Prior Therapy CTCAE Grades | Exception Relationship Alopecia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C1514463
UMLS CUI [1,4]
C1516728
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C0002170
known allergies, hypersensitivity, or intolerance to carlumab or its excipients or clinically significant reactions to chimeric or human proteins
Beskrivning

Hypersensitivity Carlumab | Intolerance to Carlumab | Hypersensitivity Carlumab Excipient | Intolerance to Carlumab Excipient | Reaction Clinical Significance Fusion protein | Reaction Clinical Significance Proteins Human

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2346793
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C2346793
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C2346793
UMLS CUI [3,3]
C0015237
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C2346793
UMLS CUI [4,3]
C0015237
UMLS CUI [5,1]
C0443286
UMLS CUI [5,2]
C2826293
UMLS CUI [5,3]
C0162768
UMLS CUI [6,1]
C0443286
UMLS CUI [6,2]
C2826293
UMLS CUI [6,3]
C0033684
UMLS CUI [6,4]
C0086418
vaccinated with live, attenuated vaccines within 4 weeks prior to the first dose of study agent
Beskrivning

Vaccines, Attenuated

Datatyp

boolean

Alias
UMLS CUI [1]
C0042211
Tillbaka till toppen

Similar models

Eligibility Prostate Cancer NCT00992186

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate
Item
histological documentation of adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1])
Docetaxel Prior Chemotherapy Quantity | Disease Progression Post Therapeutic procedure
Item
received at least 1 but no more than 2 prior docetaxel-based chemotherapy regimens and had disease progression following the last therapy
boolean
C0246415 (UMLS CUI [1,1])
C1514457 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0242656 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
Prostate specific antigen measurement
Item
serum prostate specific antigen (psa) greater than or equal to 5.0 nanogram/milliliter (ng/ml) within 4 weeks prior to the first dose of study agent
boolean
C0201544 (UMLS CUI [1])
Orchiectomy | Testosterone measurement | Medical Castration | Chemical male castration
Item
orchiectomy (surgery to remove one or both testicles) or testosterone less than 50 nanogram/deciliter by means of pharmacological/chemical castration within 4 weeks prior to the first dose of study agent
boolean
C0029189 (UMLS CUI [1])
C0523912 (UMLS CUI [2])
C1513054 (UMLS CUI [3])
C0455189 (UMLS CUI [4])
Docetaxel Prior Chemotherapy
Item
at least 6 weeks from prior docetaxel chemotherapy regimen to first dose of study agent
boolean
C0246415 (UMLS CUI [1,1])
C1514457 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Hormone Therapy Withdrawal Response | Prostatic specific antigen decreased | Raised prostate specific antigen Previous | Improvement Symptomatic
Item
experience a hormonal treatment withdrawal response (including a lowering of psa that was previously rising or symptomatic improvement)
boolean
C0279025 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
C1704632 (UMLS CUI [1,3])
C0178414 (UMLS CUI [2])
C0178415 (UMLS CUI [3,1])
C0205156 (UMLS CUI [3,2])
C2986411 (UMLS CUI [4,1])
C0231220 (UMLS CUI [4,2])
CNS metastases | CNS metastases Symptomatic
Item
known or symptomatic central nervous system metastases
boolean
C0686377 (UMLS CUI [1])
C0686377 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
Toxicity Due to Prior Therapy CTCAE Grades | Exception Relationship Alopecia
Item
residual toxicities resulting from previous therapy that are grade 2 or more (except for alopecia)
boolean
C0600688 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,3])
C1516728 (UMLS CUI [1,4])
C1705847 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0002170 (UMLS CUI [2,3])
Hypersensitivity Carlumab | Intolerance to Carlumab | Hypersensitivity Carlumab Excipient | Intolerance to Carlumab Excipient | Reaction Clinical Significance Fusion protein | Reaction Clinical Significance Proteins Human
Item
known allergies, hypersensitivity, or intolerance to carlumab or its excipients or clinically significant reactions to chimeric or human proteins
boolean
C0020517 (UMLS CUI [1,1])
C2346793 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C2346793 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C2346793 (UMLS CUI [3,2])
C0015237 (UMLS CUI [3,3])
C1744706 (UMLS CUI [4,1])
C2346793 (UMLS CUI [4,2])
C0015237 (UMLS CUI [4,3])
C0443286 (UMLS CUI [5,1])
C2826293 (UMLS CUI [5,2])
C0162768 (UMLS CUI [5,3])
C0443286 (UMLS CUI [6,1])
C2826293 (UMLS CUI [6,2])
C0033684 (UMLS CUI [6,3])
C0086418 (UMLS CUI [6,4])
Vaccines, Attenuated
Item
vaccinated with live, attenuated vaccines within 4 weeks prior to the first dose of study agent
boolean
C0042211 (UMLS CUI [1])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

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