Información:
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ID
34646
Descripción
Effects of Administration of Fostamatinib on Blood Concentrations of an Oral Contraceptive in Healthy Female Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT01276262
Link
https://clinicaltrials.gov/show/NCT01276262
Palabras clave
Versiones (1)
- 22/1/19 22/1/19 -
Titular de derechos de autor
See clinicaltrials.gov
Subido en
22 de enero de 2019
DOI
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Licencia
Creative Commons BY 4.0
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Eligibility Scientific Terminology Rheumatoid Arthritis, Healthy Female Volunteers, Pharmacokinetics, Oral Contraceptive, Drug-drug Interaction NCT01276262
Eligibility Scientific Terminology Rheumatoid Arthritis, Healthy Female Volunteers, Pharmacokinetics, Oral Contraceptive, Drug-drug Interaction NCT01276262
Similar models
Eligibility Scientific Terminology Rheumatoid Arthritis, Healthy Female Volunteers, Pharmacokinetics, Oral Contraceptive, Drug-drug Interaction NCT01276262
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Gender | Age | Healthy | Pregnancy Absent | Planned Pregnancy Absent
Item
female subjects of age 18 to 45 years, inclusive, who are healthy, non-pregnant, not planning pregnancy within the study period
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C3898900 (UMLS CUI [3])
C0032961 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0032992 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0001779 (UMLS CUI [2])
C3898900 (UMLS CUI [3])
C0032961 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0032992 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Contraceptive methods Willing | Barrier Contraception Double | Female Condoms | Vaginal contraceptive diaphragm | Vaginal Spermicides
Item
willing to use a highly effective method of birth control, ie, double barrier method contraception (condom and diaphragm with spermicide) from the first day of period 1 until 28 days after the last dose
boolean
C0700589 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C0004764 (UMLS CUI [2,1])
C0205173 (UMLS CUI [2,2])
C0221829 (UMLS CUI [3])
C0042241 (UMLS CUI [4])
C0087145 (UMLS CUI [5])
C0600109 (UMLS CUI [1,2])
C0004764 (UMLS CUI [2,1])
C0205173 (UMLS CUI [2,2])
C0221829 (UMLS CUI [3])
C0042241 (UMLS CUI [4])
C0087145 (UMLS CUI [5])
Body Weight | Body mass index
Item
body weight of at least 50 kg and body mass index (bmi) between 18 and 30 kg/m2 inclusive
boolean
C0005910 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
C1305855 (UMLS CUI [2])
Pregnancy test negative Quantity
Item
two negative pregnancy tests at least 7 days apart
boolean
C0427780 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,2])
Disease Clinical Significance
Item
history of any clinically significant disease or disorder
boolean
C0012634 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,2])
Gastrointestinal Disease | Liver disease | Kidney Disease
Item
history or presence of gastrointestinal, hepatic, or renal disease
boolean
C0017178 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0023895 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
Condition Medical contraindication Microgynon 30
Item
any condition listed as a contraindication in the microgynon® 30 labelling
boolean
C0348080 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])
C0591784 (UMLS CUI [1,3])
C1301624 (UMLS CUI [1,2])
C0591784 (UMLS CUI [1,3])
Absolute neutrophil count
Item
absolute neutrophil count less than 2.5 x 109/l.
boolean
C0948762 (UMLS CUI [1])