ID

34646

Description

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

Keywords

  1. 1/22/19 1/22/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 22, 2019

DOI

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License

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

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
female subjects of age 18 to 45 years, inclusive, who are healthy, non-pregnant, not planning pregnancy within the study period
Description

Gender | Age | Healthy | Pregnancy Absent | Planned Pregnancy Absent

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3]
C3898900
UMLS CUI [4,1]
C0032961
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0032992
UMLS CUI [5,2]
C0332197
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
Description

Contraceptive methods Willing | Barrier Contraception Double | Female Condoms | Vaginal contraceptive diaphragm | Vaginal Spermicides

Data type

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0600109
UMLS CUI [2,1]
C0004764
UMLS CUI [2,2]
C0205173
UMLS CUI [3]
C0221829
UMLS CUI [4]
C0042241
UMLS CUI [5]
C0087145
body weight of at least 50 kg and body mass index (bmi) between 18 and 30 kg/m2 inclusive
Description

Body Weight | Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C0005910
UMLS CUI [2]
C1305855
two negative pregnancy tests at least 7 days apart
Description

Pregnancy test negative Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0427780
UMLS CUI [1,2]
C1265611
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of any clinically significant disease or disorder
Description

Disease Clinical Significance

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2826293
history or presence of gastrointestinal, hepatic, or renal disease
Description

Gastrointestinal Disease | Liver disease | Kidney Disease

Data type

boolean

Alias
UMLS CUI [1]
C0017178
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0022658
any condition listed as a contraindication in the microgynon® 30 labelling
Description

Condition Medical contraindication Microgynon 30

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1301624
UMLS CUI [1,3]
C0591784
absolute neutrophil count less than 2.5 x 109/l.
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762

Similar models

Eligibility Scientific Terminology Rheumatoid Arthritis, Healthy Female Volunteers, Pharmacokinetics, Oral Contraceptive, Drug-drug Interaction NCT01276262

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
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])
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])
Item Group
C0680251 (UMLS CUI)
Disease Clinical Significance
Item
history of any clinically significant disease or disorder
boolean
C0012634 (UMLS CUI [1,1])
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])
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])
Absolute neutrophil count
Item
absolute neutrophil count less than 2.5 x 109/l.
boolean
C0948762 (UMLS CUI [1])

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