ID

41654

Description

The primary objective of this study was to demonstrate bioequivalence between eltrombopag oral film-coated tablets manufactured at Research and Development (R&D) and Commercial sites. The subject participants each went through two dosing periods (Period 1 and Period 2), during each of which they received a single dose of eltrombopag. The dosing periods were separated by a washout of at least 10 days. For each period, subjects had to perform a visit on the day before and one on the day of the administration of the drug. Furthermore, the protocol-defined visits included a screening visit and a follow-up visit. Study ID: 105122 Clinical Study ID: 105122 Study Title: Phase I Bioequivalence Study for SB 497115 GR Phase II and Phase III Tablets Sponsor: GlaxoSmithKline Phase: phase 1 Study Recruitment Status: Completed Generic Name: Eltrombopag Study Indication: Thrombocytopenia To assess any further potential impact on subject eligibility with regard to safety, the investigator must refer to the study document(s) for detailed information regarding warnings, precautions, contraindications, adverse events, and other significant data pertaining to the investigational product(s) being used in this study, please refer to the Clinical Investigator Brochure for more detailed information [GSK Document Number UM2005/00217/00]. This form has to be filled out at the Screening Visit.

Keywords

  1. 12/1/20 12/1/20 -
  2. 12/4/20 12/4/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

December 4, 2020

DOI

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License

Creative Commons BY-NC 4.0

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GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122

Eligibility Criteria

  1. StudyEvent: ODM
    1. Eligibility Criteria
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
date of visit
Description

date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
subject ID
Description

subject ID

Data type

text

Alias
UMLS CUI [1]
C2348585
eligibility question
Description

eligibility question

Alias
UMLS CUI-1
C0013893
did the subject meet all the entry criteria?
Description

clinical trial eligibility criteria fulfilled

Data type

text

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C1550543
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
healthy subjects with no clinically significant abnormalities identified by physician by evaluation of medical history, physical examination, clinical laboratory tests or electrocardiogram (ECG)
Description

healthy with no clinically significant abnormalities in medical history, physical examination, clinical laboratory tests or electrocardiogram (ECG)

Data type

boolean

Alias
UMLS CUI [1]
C3898900
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C1704258
UMLS CUI [2,3]
C2985739
UMLS CUI [2,4]
C0262926
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C1704258
UMLS CUI [3,3]
C2985739
UMLS CUI [3,4]
C0031809
UMLS CUI [4,1]
C0332197
UMLS CUI [4,2]
C1704258
UMLS CUI [4,3]
C2985739
UMLS CUI [4,4]
C0022885
UMLS CUI [5,1]
C0332197
UMLS CUI [5,2]
C1704258
UMLS CUI [5,3]
C2985739
UMLS CUI [5,4]
C1623258
male and female subjects between the ages of 18 to 55 years
Description

gender, age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
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)
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0232973
UMLS CUI [2]
C2826207
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0205160
UMLS CUI [4,1]
C0232969
UMLS CUI [4,2]
C0020699
UMLS CUI [5,1]
C0232969
UMLS CUI [5,2]
C0278321
UMLS CUI [6,1]
C0232970
UMLS CUI [6,2]
C0002453
UMLS CUI [7,1]
C0232970
UMLS CUI [7,2]
C0337434
UMLS CUI [8,1]
C0232970
UMLS CUI [8,2]
C0202022
UMLS CUI [9,1]
C3831118
UMLS CUI [9,2]
C0430061
UMLS CUI [10,1]
C3831118
UMLS CUI [10,2]
C0700589
UMLS CUI [10,3]
C2348563
body weight ≥ 50 kg for males and ≥ 45 kg for females
Description

body weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
body mass index in the range of 19 to 30 kg/m^2
Description

body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
subject was able to understand and comply with protocol requirements, instructions and restrictions
Description

understand and comply with protocol requirements, instructions and restrictions

Data type

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2,1]
C1273101
UMLS CUI [2,2]
C2348563
UMLS CUI [2,3]
C1442085
UMLS CUI [3,1]
C1273101
UMLS CUI [3,2]
C2348563
UMLS CUI [3,3]
C1514873
UMLS CUI [4,1]
C1273101
UMLS CUI [4,2]
C2348563
UMLS CUI [4,3]
C0449295
subject was capable of giving written informed consent
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
any clinically relevant abnormality identified on the screening history, physical or laboratory examination or 12-lead ECG
Description

clinically relevant abnormality identified on the screening history, physical or laboratory examination or 12-lead ECG

Data type

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0262926
UMLS CUI [2,1]
C1704258
UMLS CUI [2,2]
C2985739
UMLS CUI [2,3]
C0031809
UMLS CUI [3,1]
C1704258
UMLS CUI [3,2]
C2985739
UMLS CUI [3,3]
C0260877
UMLS CUI [4,1]
C1704258
UMLS CUI [4,2]
C2985739
UMLS CUI [4,3]
C0430456
prolonged QT-interval, corrected (QTc; Bazett's) at screening (for females </=50yo >470msex; for females >50yo >480msec; for males >470msec)
Description

prolonged QT-interval, corrected (QTc; Bazett's) at screening

Data type

boolean

Alias
UMLS CUI [1,1]
C1969409
UMLS CUI [1,2]
C1882512
history of gilbert syndrom
Description

gilbert syndrom

Data type

boolean

Alias
UMLS CUI [1]
C0017551
previous history of deep vein thrombosis or any other thromboembolic event
Description

history of deep vein thrombosis or any other thromboembolic event

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0149871
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0205394
UMLS CUI [2,3]
C0040038
history of sensitivity to heparin, or heparin-induced thrombocytopenia
Description

history of sensitivity to heparin, or heparin-induced thrombocytopenia

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0020517
UMLS CUI [1,3]
C0019134
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0272285
history of sensitivity to the study medications, or their components
Description

history of sensitivity to the study medications, or their components

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0020517
UMLS CUI [1,3]
C0013230
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0020517
UMLS CUI [2,3]
C0013230
UMLS CUI [2,4]
C0015237
history of myocardial infarction, stroke, or sudden death in a first degree family member of < =60years
Description

history of early myocardial infarction, stroke, or sudden death in a first degree family member

Data type

boolean

Alias
UMLS CUI [1,1]
C0241889
UMLS CUI [1,2]
C1517194
UMLS CUI [1,3]
C0027051
UMLS CUI [1,4]
C1833334
UMLS CUI [2,1]
C0559159
UMLS CUI [2,2]
C1517194
UMLS CUI [2,3]
C1833334
UMLS CUI [3,1]
C2315244
UMLS CUI [3,2]
C1517194
UMLS CUI [3,3]
C1833334
history of thrombocytopenia or bleeding due to abnormal platelet number or function
Description

history of thrombocytopenia or bleeding due to abnormal platelet number or function

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0040034
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0019080
UMLS CUI [2,3]
C0580317
UMLS CUI [3,1]
C0262926
UMLS CUI [3,2]
C0019080
UMLS CUI [3,3]
C1254881
UMLS CUI [3,4]
C0205161
history of platelet clumping that prevents reliable mesurement of platelet counts
Description

history of platelet clumping preventing reliable mesurement of platelet counts

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0427569
UMLS CUI [1,3]
C1292733
UMLS CUI [1,4]
C3858758
UMLS CUI [1,5]
C0032181
history of atrial fibrillation, mitral valve prolapse, significant heart murmur or vascular bruit
Description

history of atrial fibrillation, mitral valve prolapse, significant heart murmur or vascular bruit

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0004238
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0026267
UMLS CUI [3,1]
C0262926
UMLS CUI [3,2]
C0750502
UMLS CUI [3,3]
C0018808
UMLS CUI [4,1]
C0262926
UMLS CUI [4,2]
C0232112
elevated blood pressure at screening (systolic >140mmHg, diastolic >85mmHg)
Description

elevated blood pressure at screening

Data type

boolean

Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C3163633
UMLS CUI [1,3]
C0220908
clinically significant liver function tests (LFTs) outside the reference range at screening
Description

clinically significant abnormal liver function tests (LFTs)

Data type

boolean

Alias
UMLS CUI [1,1]
C0205161
UMLS CUI [1,2]
C0023901
UMLS CUI [1,3]
C2826293
clotting factor abnormalities associated with hypercoagulability, specifically factor V Leiden, Protein C or Protein S deficiency or antithrombin III deficiency
Description

clotting factor abnormalities associated with hypercoagulability, specifically factor V Leiden, Protein C or Protein S deficiency or antithrombin III deficiency

Data type

boolean

Alias
UMLS CUI [1,1]
C0005789
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0332281
UMLS CUI [1,4]
C0398623
UMLS CUI [2]
C0380964
UMLS CUI [3]
C0398625
UMLS CUI [4]
C0242666
UMLS CUI [5]
C0272375
CBC and/or reticulocyte count outside the reference range
Description

abnormal CBC and/or reticulocyte count

Data type

boolean

Alias
UMLS CUI [1,1]
C0205161
UMLS CUI [1,2]
C0009555
UMLS CUI [2,1]
C0205161
UMLS CUI [2,2]
C0206161
female subjects of childbearing potential who are unwilling or unable to use an appropriate method of contraception as described in section 5.2.1.
Description

subjects of childbearing potential who are unwilling or unable to use an appropriate method of contraception

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C2348563
UMLS CUI [1,3]
C0700589
UMLS CUI [1,4]
C0558080
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C2348563
UMLS CUI [2,3]
C0700589
UMLS CUI [2,4]
C1299582
for female subjects, a positive beta-hCG at screening or pre-dose in any period
Description

serum pregnancy test (beta-hCG) positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0430060
UMLS CUI [1,2]
C1446409
for female subjects, currently receiving hormone replacement therapy
Description

females currently receiving hormone replacement therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0521116
UMLS CUI [1,2]
C0282402
UMLS CUI [1,3]
C0086287
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
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0086582
UMLS CUI [1,2]
C0558080
UMLS CUI [1,3]
C1171321
UMLS CUI [1,4]
C0032961
UMLS CUI [2,1]
C0086582
UMLS CUI [2,2]
C0558080
UMLS CUI [2,3]
C1171321
UMLS CUI [2,4]
C0006147
UMLS CUI [3,1]
C0086582
UMLS CUI [3,2]
C0558080
UMLS CUI [3,3]
C0679782
UMLS CUI [3,4]
C0032961
UMLS CUI [4,1]
C0086582
UMLS CUI [4,2]
C0558080
UMLS CUI [4,3]
C0679782
UMLS CUI [4,4]
C0006147
UMLS CUI [5,1]
C0086582
UMLS CUI [5,2]
C0558080
UMLS CUI [5,3]
C0679782
UMLS CUI [5,4]
C0332287
UMLS CUI [5,5]
C0086287
UMLS CUI [5,6]
C0700589
positive for HIV, hepatitis B virus or hepatitis C virus assays at screening
Description

positive for HIV, hepatitis B virus or hepatitis C virus assays

Data type

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C2748184
UMLS CUI [3]
C2748185
positive urine drug screen including alcohol at screening or pre-dose
Description

urine drug screen and/or urine alcohol test positive

Data type

boolean

Alias
UMLS CUI [1]
C0743300
UMLS CUI [2]
C1112219
history of alcohol/drug abuse or dependence within 12 months of the study
Description

recent alcohol/drug abuse or dependence

Data type

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C0085762
UMLS CUI [2,1]
C0332185
UMLS CUI [2,2]
C0013146
UMLS CUI [3,1]
C0332185
UMLS CUI [3,2]
C1510472
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)
Description

recent alcohol consumption in units/week

Data type

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C0560579
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
Description

urinary cotinine levels indicative of smoking. Recent history of regular use of tobacco- or nicotine-containing products

Data type

boolean

Alias
UMLS CUI [1,1]
C1697737
UMLS CUI [1,2]
C0037369
UMLS CUI [2,1]
C0332185
UMLS CUI [2,2]
C0543414
UMLS CUI [2,3]
C0205272
UMLS CUI [3,1]
C0332185
UMLS CUI [3,2]
C0205272
UMLS CUI [3,3]
C1514468
UMLS CUI [3,4]
C0028040
treatment with an investigational drug within 30 days or five half-lives (whichever is longer) preceding the first dose of study medication
Description

recent treatment with an investigational drug

Data type

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C0013230
exposure to more than four new chemical entities within 12 months prior to the first dosing day
Description

recent exposure to multiple new chemical entities

Data type

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C1265611
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.
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C0304227
UMLS CUI [2,1]
C0332185
UMLS CUI [2,2]
C0013231
UMLS CUI [3]
C0004057
UMLS CUI [4]
C0003211
UMLS CUI [5]
C0042890
UMLS CUI [6]
C1504473
UMLS CUI [7]
C0242295
UMLS CUI [8]
C0936242
UMLS CUI [9,1]
C0332300
UMLS CUI [9,2]
C0000970
UMLS CUI [10,1]
C0332300
UMLS CUI [10,2]
C2242640
UMLS CUI [10,3]
C0205360
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
Description

consumption of liquid antacids or or chewable antacids during the clinical trial period

Data type

boolean

Alias
UMLS CUI [1,1]
C0347984
UMLS CUI [1,2]
C2347804
UMLS CUI [1,3]
C0003138
UMLS CUI [1,4]
C0302908
UMLS CUI [2,1]
C0347984
UMLS CUI [2,2]
C2347804
UMLS CUI [2,3]
C0003138
UMLS CUI [2,4]
C0304290
consumption of grapefruit, pomelo or seville oranges from the screening visit until the follow-up visit
Description

consumption of grapefruit, pomelo or seville oranges during the clinical trial

Data type

boolean

Alias
UMLS CUI [1,1]
C0995150
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C2347804
UMLS CUI [2,1]
C1006780
UMLS CUI [2,2]
C0347984
UMLS CUI [2,3]
C2347804
UMLS CUI [3,1]
C0330922
UMLS CUI [3,2]
C0347984
UMLS CUI [3,3]
C2347804
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
Description

recent donation of plasma or blood

Data type

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C0860067
UMLS CUI [2,1]
C0332185
UMLS CUI [2,2]
C0005794
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
Description

clinical trial eligibility criteria exemption

Data type

text

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348482

Similar models

Eligibility Criteria

  1. StudyEvent: ODM
    1. Eligibility Criteria
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
date of visit
Item
date of visit
date
C1320303 (UMLS CUI [1])
subject ID
Item
subject ID
text
C2348585 (UMLS CUI [1])
Item Group
eligibility question
C0013893 (UMLS CUI-1)
Item
did the subject meet all the entry criteria?
text
C1516637 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Code List
did the subject meet all the entry criteria?
CL Item
Yes (Y)
CL Item
No, please select all boxes corresponding to violations of any inclusion/exclusion criteria (N)
Item Group
C1512693 (UMLS CUI-1)
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])
Item Group
C0680251 (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])

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