ID

38083

Descripción

Fosaprepitant Dimeglumine and Granisetron Transdermal System in Preventing Nausea and Vomiting in Patients With Breast Cancer Undergoing Chemotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT01649258

Link

https://clinicaltrials.gov/show/NCT01649258

Palabras clave

Versiones (1)
  1. 16/9/19 16/9/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

16 de septiembre de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01649258

Inglés

Eligibility Breast Cancer NCT01649258

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with histologically confirmed breast cancer scheduled to receive chemotherapy with doxorubicin and cyclophosphamide (adjuvant or neoadjuvant)
Descripción

Breast Carcinoma | Adjuvant Chemotherapy Scheduled | Neoadjuvant Chemotherapy Scheduled | Doxorubicin | Cyclophosphamide

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2,1]
C0085533
UMLS CUI [2,2]
C0205539
UMLS CUI [3,1]
C0600558
UMLS CUI [3,2]
C3665472
UMLS CUI [3,3]
C0205539
UMLS CUI [4]
C0013089
UMLS CUI [5]
C0010583
eastern cooperative oncology group (ecog) performance status of 0-1
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
projected life expectancy of at least 3 months
Descripción

Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
provision of informed consent prior to any study-related procedures
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
negative pregnancy test for women of childbearing potential
Descripción

Childbearing Potential Pregnancy test negative

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
absolute neutrophil count (anc) >= 1500/mm^3
Descripción

Absolute neutrophil count

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0948762
platelet count >= 100,000 cells/mm^3
Descripción

Platelet Count measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032181
hemoglobin >= 9.0g/dl
Descripción

Hemoglobin measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0518015
serum creatinine =< 1.5 mg/dl
Descripción

Creatinine measurement, serum

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201976
aspartate aminotransferase (ast) or alanine aminotransferase (alt) =< 2.5 x upper limit of normal (uln)
Descripción

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
alkaline phosphatase =< 2.5 x upper limit of normal; in patients with bone metastasis and no evidence of liver metastasis and bilirubin =< upper limit of normal an alkaline phosphatase =< 5 uln will be allowed
Descripción

Alkaline phosphatase measurement | Secondary malignant neoplasm of bone | Secondary malignant neoplasm of liver Absent | Serum total bilirubin measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201850
UMLS CUI [2]
C0153690
UMLS CUI [3,1]
C0494165
UMLS CUI [3,2]
C0332197
UMLS CUI [4]
C1278039
serum bilirubin =< 1.0 mg/dl
Descripción

Serum total bilirubin measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1278039
no other concomitant therapy directed at the cancer is allowed
Descripción

Absence Targeted Therapy concomitant Malignant Neoplasm

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C2985566
UMLS CUI [1,3]
C0521115
UMLS CUI [1,4]
C0006826
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
allergy or intolerance to 5ht3 or nk-1 antagonists and dexamethasone
Descripción

Hypersensitivity 5-HT3 Receptor Antagonists | Intolerance to 5-HT3 Receptor Antagonists | Hypersensitivity NK-1 Receptor Antagonist | Intolerance to NK-1 Receptor Antagonist | Dexamethasone allergy | Intolerance to Dexamethasone

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2936526
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C2936526
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C3537229
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C3537229
UMLS CUI [5]
C0571611
UMLS CUI [6,1]
C1744706
UMLS CUI [6,2]
C0011777
use of another antiemetic agent (5ht3 antagonists, phenothiazines, butyrophenones, cannabinoids, metoclopramide, or corticosteroids) within 72 hours prior to day 1 of the study
Descripción

Antiemetics | 5-HT3 Receptor Antagonists | Phenothiazines | Butyrophenones | Cannabinoids | Metoclopramide | Adrenal Cortex Hormones

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003297
UMLS CUI [2]
C2936526
UMLS CUI [3]
C0031436
UMLS CUI [4]
C0006525
UMLS CUI [5]
C0006864
UMLS CUI [6]
C0025853
UMLS CUI [7]
C0001617
use of anticoagulant agent (warfarin, coumadin, jantoven, marevan, lawarin, waran, or warfant)
Descripción

Anticoagulants | Warfarin | Coumadin | Jantoven | Other Coding | Waran | Warfant

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003280
UMLS CUI [2]
C0043031
UMLS CUI [3]
C0699129
UMLS CUI [4]
C1330361
UMLS CUI [5]
C3846158
UMLS CUI [6]
C1520124
UMLS CUI [7]
C1564397
an episode of vomiting or retching within 24 hours before the start of the initial treatment with chemotherapy
Descripción

Episode of Vomiting | Episode of Retching

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332189
UMLS CUI [1,2]
C0042963
UMLS CUI [2,1]
C0332189
UMLS CUI [2,2]
C0232602
severe concurrent illness other than neoplasia
Descripción

Comorbidity Severe | Exception Neoplastic disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1882062
gastrointestinal obstruction or an active peptic ulcer
Descripción

Gastrointestinal obstruction | Peptic Ulcer

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0236124
UMLS CUI [2]
C0030920
patients who are pregnant or breast feeding because aprepitant may be harmful to the developing fetus and newborn
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Breast Cancer NCT01649258

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma | Adjuvant Chemotherapy Scheduled | Neoadjuvant Chemotherapy Scheduled | Doxorubicin | Cyclophosphamide
Item
patients with histologically confirmed breast cancer scheduled to receive chemotherapy with doxorubicin and cyclophosphamide (adjuvant or neoadjuvant)
boolean
C0678222 (UMLS CUI [1])
C0085533 (UMLS CUI [2,1])
C0205539 (UMLS CUI [2,2])
C0600558 (UMLS CUI [3,1])
C3665472 (UMLS CUI [3,2])
C0205539 (UMLS CUI [3,3])
C0013089 (UMLS CUI [4])
C0010583 (UMLS CUI [5])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0-1
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
projected life expectancy of at least 3 months
boolean
C0023671 (UMLS CUI [1])
Informed Consent
Item
provision of informed consent prior to any study-related procedures
boolean
C0021430 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative
Item
negative pregnancy test for women of childbearing potential
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Absolute neutrophil count
Item
absolute neutrophil count (anc) >= 1500/mm^3
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count >= 100,000 cells/mm^3
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
hemoglobin >= 9.0g/dl
boolean
C0518015 (UMLS CUI [1])
Creatinine measurement, serum
Item
serum creatinine =< 1.5 mg/dl
boolean
C0201976 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
aspartate aminotransferase (ast) or alanine aminotransferase (alt) =< 2.5 x upper limit of normal (uln)
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Alkaline phosphatase measurement | Secondary malignant neoplasm of bone | Secondary malignant neoplasm of liver Absent | Serum total bilirubin measurement
Item
alkaline phosphatase =< 2.5 x upper limit of normal; in patients with bone metastasis and no evidence of liver metastasis and bilirubin =< upper limit of normal an alkaline phosphatase =< 5 uln will be allowed
boolean
C0201850 (UMLS CUI [1])
C0153690 (UMLS CUI [2])
C0494165 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C1278039 (UMLS CUI [4])
Serum total bilirubin measurement
Item
serum bilirubin =< 1.0 mg/dl
boolean
C1278039 (UMLS CUI [1])
Absence Targeted Therapy concomitant Malignant Neoplasm
Item
no other concomitant therapy directed at the cancer is allowed
boolean
C0332197 (UMLS CUI [1,1])
C2985566 (UMLS CUI [1,2])
C0521115 (UMLS CUI [1,3])
C0006826 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity 5-HT3 Receptor Antagonists | Intolerance to 5-HT3 Receptor Antagonists | Hypersensitivity NK-1 Receptor Antagonist | Intolerance to NK-1 Receptor Antagonist | Dexamethasone allergy | Intolerance to Dexamethasone
Item
allergy or intolerance to 5ht3 or nk-1 antagonists and dexamethasone
boolean
C0020517 (UMLS CUI [1,1])
C2936526 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C2936526 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C3537229 (UMLS CUI [3,2])
C1744706 (UMLS CUI [4,1])
C3537229 (UMLS CUI [4,2])
C0571611 (UMLS CUI [5])
C1744706 (UMLS CUI [6,1])
C0011777 (UMLS CUI [6,2])
Antiemetics | 5-HT3 Receptor Antagonists | Phenothiazines | Butyrophenones | Cannabinoids | Metoclopramide | Adrenal Cortex Hormones
Item
use of another antiemetic agent (5ht3 antagonists, phenothiazines, butyrophenones, cannabinoids, metoclopramide, or corticosteroids) within 72 hours prior to day 1 of the study
boolean
C0003297 (UMLS CUI [1])
C2936526 (UMLS CUI [2])
C0031436 (UMLS CUI [3])
C0006525 (UMLS CUI [4])
C0006864 (UMLS CUI [5])
C0025853 (UMLS CUI [6])
C0001617 (UMLS CUI [7])
Anticoagulants | Warfarin | Coumadin | Jantoven | Other Coding | Waran | Warfant
Item
use of anticoagulant agent (warfarin, coumadin, jantoven, marevan, lawarin, waran, or warfant)
boolean
C0003280 (UMLS CUI [1])
C0043031 (UMLS CUI [2])
C0699129 (UMLS CUI [3])
C1330361 (UMLS CUI [4])
C3846158 (UMLS CUI [5])
C1520124 (UMLS CUI [6])
C1564397 (UMLS CUI [7])
Episode of Vomiting | Episode of Retching
Item
an episode of vomiting or retching within 24 hours before the start of the initial treatment with chemotherapy
boolean
C0332189 (UMLS CUI [1,1])
C0042963 (UMLS CUI [1,2])
C0332189 (UMLS CUI [2,1])
C0232602 (UMLS CUI [2,2])
Comorbidity Severe | Exception Neoplastic disease
Item
severe concurrent illness other than neoplasia
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1882062 (UMLS CUI [2,2])
Gastrointestinal obstruction | Peptic Ulcer
Item
gastrointestinal obstruction or an active peptic ulcer
boolean
C0236124 (UMLS CUI [1])
C0030920 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
patients who are pregnant or breast feeding because aprepitant may be harmful to the developing fetus and newborn
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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