healthy with no clinically significant abnormalities in medical history, physical examination, clinical laboratory tests or electrocardiogram (ECG)
Item
healthy subjects with no clinically significant abnormalities identified by physician by evaluation of medical history, physical examination, clinical laboratory tests or electrocardiogram (ECG)
boolean
C3898900 (UMLS CUI [1])
C0332197 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C2985739 (UMLS CUI [2,3])
C0262926 (UMLS CUI [2,4])
C0332197 (UMLS CUI [3,1])
C1704258 (UMLS CUI [3,2])
C2985739 (UMLS CUI [3,3])
C0031809 (UMLS CUI [3,4])
C0332197 (UMLS CUI [4,1])
C1704258 (UMLS CUI [4,2])
C2985739 (UMLS CUI [4,3])
C0022885 (UMLS CUI [4,4])
C0332197 (UMLS CUI [5,1])
C1704258 (UMLS CUI [5,2])
C2985739 (UMLS CUI [5,3])
C1623258 (UMLS CUI [5,4])
gender, age
Item
male and female subjects between the ages of 18 to 55 years
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
not pregnant, not lactating females if they are in one of the following categories: 1) non-childbearing potential including pre-menopausal females with documented (medical report verification) hysterectomy or bilateral oophorectomy, or post-menopausal females defined as being amenorrheic and having estradiol and follicle stimulating hormone levels consistent with menopause 2) child bearing potential with negative beta human chorionic gonadotropin test and agreed to comply with protocol-defined contraceptive methods
Item
females that are neither pregnant nor lactating if they are in either of the following categories: 1) non-childbearing potential including pre-menopausal females with documented (medical report verification) hysterectomy or bilateral oophorectomy, or post-menopausal females were defined as being amenorrheic for greater than 1 year and having estradiol and follicle stimulating hormone levels consistent with menopause 2) child bearing potential with negative beta human chorionic gonadotropin test and agreed to comply with recognized non-hormonal contraceptive methods from screening or at least 2 weeks prior to first dose (whichever is earlier) until the Follow-up visit. Recognized non-hormonal contraceptive methods include: complete abstinence from intercourse, two forms of barrier contraception, or intrauterine device (IUD)
boolean
C0232973 (UMLS CUI [1])
C2826207 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0205160 (UMLS CUI [3,2])
C0232969 (UMLS CUI [4,1])
C0020699 (UMLS CUI [4,2])
C0232969 (UMLS CUI [5,1])
C0278321 (UMLS CUI [5,2])
C0232970 (UMLS CUI [6,1])
C0002453 (UMLS CUI [6,2])
C0232970 (UMLS CUI [7,1])
C0337434 (UMLS CUI [7,2])
C0232970 (UMLS CUI [8,1])
C0202022 (UMLS CUI [8,2])
C3831118 (UMLS CUI [9,1])
C0430061 (UMLS CUI [9,2])
C3831118 (UMLS CUI [10,1])
C0700589 (UMLS CUI [10,2])
C2348563 (UMLS CUI [10,3])
body weight
Item
body weight ≥ 50 kg for males and ≥ 45 kg for females
boolean
C0005910 (UMLS CUI [1])
body mass index
Item
body mass index in the range of 19 to 30 kg/m^2
boolean
C1305855 (UMLS CUI [1])
understand and comply with protocol requirements, instructions and restrictions
Item
subject was able to understand and comply with protocol requirements, instructions and restrictions
boolean
C0525058 (UMLS CUI [1])
C1273101 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
C1442085 (UMLS CUI [2,3])
C1273101 (UMLS CUI [3,1])
C2348563 (UMLS CUI [3,2])
C1514873 (UMLS CUI [3,3])
C1273101 (UMLS CUI [4,1])
C2348563 (UMLS CUI [4,2])
C0449295 (UMLS CUI [4,3])
informed consent
Item
subject was capable of giving written informed consent
boolean
C0021430 (UMLS CUI [1])
clinically relevant abnormality identified on the screening history, physical or laboratory examination or 12-lead ECG
Item
any clinically relevant abnormality identified on the screening history, physical or laboratory examination or 12-lead ECG
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C1704258 (UMLS CUI [2,1])
C2985739 (UMLS CUI [2,2])
C0031809 (UMLS CUI [2,3])
C1704258 (UMLS CUI [3,1])
C2985739 (UMLS CUI [3,2])
C0260877 (UMLS CUI [3,3])
C1704258 (UMLS CUI [4,1])
C2985739 (UMLS CUI [4,2])
C0430456 (UMLS CUI [4,3])
prolonged QT-interval, corrected (QTc; Bazett's) at screening
Item
prolonged QT-interval, corrected (QTc; Bazett's) at screening (for females </=50yo >470msex; for females >50yo >480msec; for males >470msec)
boolean
C1969409 (UMLS CUI [1,1])
C1882512 (UMLS CUI [1,2])
gilbert syndrom
Item
history of gilbert syndrom
boolean
C0017551 (UMLS CUI [1])
history of deep vein thrombosis or any other thromboembolic event
Item
previous history of deep vein thrombosis or any other thromboembolic event
boolean
C0262926 (UMLS CUI [1,1])
C0149871 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0040038 (UMLS CUI [2,3])
history of sensitivity to heparin, or heparin-induced thrombocytopenia
Item
history of sensitivity to heparin, or heparin-induced thrombocytopenia
boolean
C0262926 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0019134 (UMLS CUI [1,3])
C0262926 (UMLS CUI [2,1])
C0272285 (UMLS CUI [2,2])
history of sensitivity to the study medications, or their components
Item
history of sensitivity to the study medications, or their components
boolean
C0262926 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C0262926 (UMLS CUI [2,1])
C0020517 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C0015237 (UMLS CUI [2,4])
history of early myocardial infarction, stroke, or sudden death in a first degree family member
Item
history of myocardial infarction, stroke, or sudden death in a first degree family member of < =60years
boolean
C0241889 (UMLS CUI [1,1])
C1517194 (UMLS CUI [1,2])
C0027051 (UMLS CUI [1,3])
C1833334 (UMLS CUI [1,4])
C0559159 (UMLS CUI [2,1])
C1517194 (UMLS CUI [2,2])
C1833334 (UMLS CUI [2,3])
C2315244 (UMLS CUI [3,1])
C1517194 (UMLS CUI [3,2])
C1833334 (UMLS CUI [3,3])
history of thrombocytopenia or bleeding due to abnormal platelet number or function
Item
history of thrombocytopenia or bleeding due to abnormal platelet number or function
boolean
C0262926 (UMLS CUI [1,1])
C0040034 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0019080 (UMLS CUI [2,2])
C0580317 (UMLS CUI [2,3])
C0262926 (UMLS CUI [3,1])
C0019080 (UMLS CUI [3,2])
C1254881 (UMLS CUI [3,3])
C0205161 (UMLS CUI [3,4])
history of platelet clumping preventing reliable mesurement of platelet counts
Item
history of platelet clumping that prevents reliable mesurement of platelet counts
boolean
C0262926 (UMLS CUI [1,1])
C0427569 (UMLS CUI [1,2])
C1292733 (UMLS CUI [1,3])
C3858758 (UMLS CUI [1,4])
C0032181 (UMLS CUI [1,5])
history of atrial fibrillation, mitral valve prolapse, significant heart murmur or vascular bruit
Item
history of atrial fibrillation, mitral valve prolapse, significant heart murmur or vascular bruit
boolean
C0262926 (UMLS CUI [1,1])
C0004238 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0026267 (UMLS CUI [2,2])
C0262926 (UMLS CUI [3,1])
C0750502 (UMLS CUI [3,2])
C0018808 (UMLS CUI [3,3])
C0262926 (UMLS CUI [4,1])
C0232112 (UMLS CUI [4,2])
elevated blood pressure at screening
Item
elevated blood pressure at screening (systolic >140mmHg, diastolic >85mmHg)
boolean
C0005823 (UMLS CUI [1,1])
C3163633 (UMLS CUI [1,2])
C0220908 (UMLS CUI [1,3])
clinically significant abnormal liver function tests (LFTs)
Item
clinically significant liver function tests (LFTs) outside the reference range at screening
boolean
C0205161 (UMLS CUI [1,1])
C0023901 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
clotting factor abnormalities associated with hypercoagulability, specifically factor V Leiden, Protein C or Protein S deficiency or antithrombin III deficiency
Item
clotting factor abnormalities associated with hypercoagulability, specifically factor V Leiden, Protein C or Protein S deficiency or antithrombin III deficiency
boolean
C0005789 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0332281 (UMLS CUI [1,3])
C0398623 (UMLS CUI [1,4])
C0380964 (UMLS CUI [2])
C0398625 (UMLS CUI [3])
C0242666 (UMLS CUI [4])
C0272375 (UMLS CUI [5])
abnormal CBC and/or reticulocyte count
Item
CBC and/or reticulocyte count outside the reference range
boolean
C0205161 (UMLS CUI [1,1])
C0009555 (UMLS CUI [1,2])
C0205161 (UMLS CUI [2,1])
C0206161 (UMLS CUI [2,2])
subjects of childbearing potential who are unwilling or unable to use an appropriate method of contraception
Item
female subjects of childbearing potential who are unwilling or unable to use an appropriate method of contraception as described in section 5.2.1.
boolean
C3831118 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C0558080 (UMLS CUI [1,4])
C3831118 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
C1299582 (UMLS CUI [2,4])
serum pregnancy test (beta-hCG) positive
Item
for female subjects, a positive beta-hCG at screening or pre-dose in any period
boolean
C0430060 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])
females currently receiving hormone replacement therapy
Item
for female subjects, currently receiving hormone replacement therapy
boolean
C0521116 (UMLS CUI [1,1])
C0282402 (UMLS CUI [1,2])
C0086287 (UMLS CUI [1,3])
unwillingness of male subjects to abstain from or use a condom during sexual intercourse with pregnant or lactating females; or unwillingness of male subjects to use a condom/spermicide, in addition to having their female partner use another form of contraception
Item
unwillingness of male subjects to abstain from or use a condom during sexual intercourse with pregnant or lactating females; or unwillingness of male subjects to use a condom/spermicide, in addition to having their female partner use another form of contraception, such as an IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, subdermal implants or a tubal ligation, if engaging in sexual intercourse with a female partner who could become pregnant. This criterion must be followed from the time of the first dose of study medication until 84 days after the last dose of study medication
boolean
C0086582 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C1171321 (UMLS CUI [1,3])
C0032961 (UMLS CUI [1,4])
C0086582 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
C1171321 (UMLS CUI [2,3])
C0006147 (UMLS CUI [2,4])
C0086582 (UMLS CUI [3,1])
C0558080 (UMLS CUI [3,2])
C0679782 (UMLS CUI [3,3])
C0032961 (UMLS CUI [3,4])
C0086582 (UMLS CUI [4,1])
C0558080 (UMLS CUI [4,2])
C0679782 (UMLS CUI [4,3])
C0006147 (UMLS CUI [4,4])
C0086582 (UMLS CUI [5,1])
C0558080 (UMLS CUI [5,2])
C0679782 (UMLS CUI [5,3])
C0332287 (UMLS CUI [5,4])
C0086287 (UMLS CUI [5,5])
C0700589 (UMLS CUI [5,6])
positive for HIV, hepatitis B virus or hepatitis C virus assays
Item
positive for HIV, hepatitis B virus or hepatitis C virus assays at screening
boolean
C0019699 (UMLS CUI [1])
C2748184 (UMLS CUI [2])
C2748185 (UMLS CUI [3])
urine drug screen and/or urine alcohol test positive
Item
positive urine drug screen including alcohol at screening or pre-dose
boolean
C0743300 (UMLS CUI [1])
C1112219 (UMLS CUI [2])
recent alcohol/drug abuse or dependence
Item
history of alcohol/drug abuse or dependence within 12 months of the study
boolean
C0332185 (UMLS CUI [1,1])
C0085762 (UMLS CUI [1,2])
C0332185 (UMLS CUI [2,1])
C0013146 (UMLS CUI [2,2])
C0332185 (UMLS CUI [3,1])
C1510472 (UMLS CUI [3,2])
recent alcohol consumption in units/week
Item
history of alcohol consumption in the past six months exceeding seven units/week for women and 14 units/week for men (where 1 unit=5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor)
boolean
C0332185 (UMLS CUI [1,1])
C0560579 (UMLS CUI [1,2])
urinary cotinine levels indicative of smoking. Recent history of regular use of tobacco- or nicotine-containing products
Item
urinary cotinine levels indicative of smoking at screening or pre-dose. History of regular use of tobacco- or nicotine-containing products within six months prior to screening
boolean
C1697737 (UMLS CUI [1,1])
C0037369 (UMLS CUI [1,2])
C0332185 (UMLS CUI [2,1])
C0543414 (UMLS CUI [2,2])
C0205272 (UMLS CUI [2,3])
C0332185 (UMLS CUI [3,1])
C0205272 (UMLS CUI [3,2])
C1514468 (UMLS CUI [3,3])
C0028040 (UMLS CUI [3,4])
recent treatment with an investigational drug
Item
treatment with an investigational drug within 30 days or five half-lives (whichever is longer) preceding the first dose of study medication
boolean
C0332185 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
recent exposure to multiple new chemical entities
Item
exposure to more than four new chemical entities within 12 months prior to the first dosing day
boolean
C0332185 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
recent use of prescription or non-prescription drugs (including aspirin and NSAIDs), vitamins, herbal and dietary supplements, or any herbal remedies containing St. Johns Wort. Except for acetaminophen and stable thyroid replacement therapy
Item
use of prescription or non-prescription drugs (including aspirin and NSAIDs), vitamins, herbal and dietary supplements, or any herbal remedies containing St. Johns Wort within seven days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of the study medication and for the duration of the trial. By exception, acetaminophen at doses of =/<2g/day and stable thyroid replacement therapy will be allowed.
boolean
C0332185 (UMLS CUI [1,1])
C0304227 (UMLS CUI [1,2])
C0332185 (UMLS CUI [2,1])
C0013231 (UMLS CUI [2,2])
C0004057 (UMLS CUI [3])
C0003211 (UMLS CUI [4])
C0042890 (UMLS CUI [5])
C1504473 (UMLS CUI [6])
C0242295 (UMLS CUI [7])
C0936242 (UMLS CUI [8])
C0332300 (UMLS CUI [9,1])
C0000970 (UMLS CUI [9,2])
C0332300 (UMLS CUI [10,1])
C2242640 (UMLS CUI [10,2])
C0205360 (UMLS CUI [10,3])
consumption of liquid antacids or or chewable antacids during the clinical trial period
Item
consumption of liquid antacids (e.g. Maalox, Mylanta, Amphogel, Milk of Magnesia) or chewable antacids (e.g. TUMS) within 48hours of the first dose of study medication until the final pharmacokinetic sample of the study
boolean
C0347984 (UMLS CUI [1,1])
C2347804 (UMLS CUI [1,2])
C0003138 (UMLS CUI [1,3])
C0302908 (UMLS CUI [1,4])
C0347984 (UMLS CUI [2,1])
C2347804 (UMLS CUI [2,2])
C0003138 (UMLS CUI [2,3])
C0304290 (UMLS CUI [2,4])
consumption of grapefruit, pomelo or seville oranges during the clinical trial
Item
consumption of grapefruit, pomelo or seville oranges from the screening visit until the follow-up visit
boolean
C0995150 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C1006780 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
C2347804 (UMLS CUI [2,3])
C0330922 (UMLS CUI [3,1])
C0347984 (UMLS CUI [3,2])
C2347804 (UMLS CUI [3,3])
recent donation of plasma or blood
Item
subjects who have donated plasma within seven days prior to the screening visit or donated 500 mL of blood within 56 days prior to the start of this study
boolean
C0332185 (UMLS CUI [1,1])
C0860067 (UMLS CUI [1,2])
C0332185 (UMLS CUI [2,1])
C0005794 (UMLS CUI [2,2])
clinical trial eligibility criteria exemption
Item
do not admit the subject into this study if any Inclusion / Exclusion criteria is checked unless an exception has been granted by the GSK Medical Monitor and subject is continuing in the study. Please clarify the exemption(s) below
text
C1516637 (UMLS CUI [1,1])
C2348482 (UMLS CUI [1,2])