Informações:
Falhas:
ID
41822
Descrição
Study ID: 103096 Clinical Study ID: 103096 Study Title: A randomised, double blind, placebo controlled, incomplete block, five-way cross-over study to investigate the effect of one week repeat dosing of GW685698X and FP on twenty-four hour serum cortisol in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Fluticasone Furoate;Fluticasone Propionate Trade Name: Fluticasone Furoate;Fluticasone Propionate Study Indication: Asthma
Palavras-chave
Versões (1)
- 22/01/2021 22/01/2021 -
Titular dos direitos
GlaxoSmithKline
Transferido a
22 de janeiro de 2021
DOI
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Licença
Creative Commons BY 4.0
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Effect of one week repeat dosing of GW685698X and FP on serum cortisol (103096)
Day 1 - Vital Signs; 12-Lead ECG; Pulmonary Function Tests; Pharmacodynamics; Local Laboratory; Urinalysis; Randomisation Number
Similar models
Day 1 - Vital Signs; 12-Lead ECG; Pulmonary Function Tests; Pharmacodynamics; Local Laboratory; Urinalysis; Randomisation Number
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Vital Signs - Pre-Dose
C0518766 (UMLS CUI-1)
C0439565 (UMLS CUI-2)
C0439565 (UMLS CUI-2)
Vital Signs - Date (Pre-Dose)
Item
Vital Signs - Date (Pre-Dose)
date
C2826644 (UMLS CUI [1])
C0439565 (UMLS CUI [2])
C0439565 (UMLS CUI [2])
Item
Vital Signs - Planned Relative Time (Pre-Dose)
integer
C0518766 (UMLS CUI [1])
C0439564 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0439565 (UMLS CUI [3])
C0439564 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0439565 (UMLS CUI [3])
Code List
Vital Signs - Planned Relative Time (Pre-Dose)
CL Item
Pre-Dose (1)
Vital Signs - Actual Time (Pre-Dose)
Item
Vital Signs - Actual Time (Pre-Dose)
time
C2826762 (UMLS CUI [1])
C0439565 (UMLS CUI [2])
C0439565 (UMLS CUI [2])
Vital Signs - Systolic Blood Pressure (Pre-Dose)
Item
Vital Signs - Systolic Blood Pressure (Pre-Dose)
integer
C0518766 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
C0871470 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
Vital Signs - Diastolic Blood Pressure (Pre-Dose)
Item
Vital Signs - Diastolic Blood Pressure (Pre-Dose)
integer
C0518766 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
C0428883 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
Vital Signs - Heart Rate (Pre-Dose)
Item
Vital Signs - Heart Rate (Pre-Dose)
integer
C0518766 (UMLS CUI [1])
C0018810 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
C0018810 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
Item Group
12-Lead ECG (Pre-Dose)
C0430456 (UMLS CUI-1)
C0439565 (UMLS CUI-2)
C0439565 (UMLS CUI-2)
Start Date of ECG (Pre-Dose)
Item
Start Date of ECG (Pre-Dose)
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0439565 (UMLS CUI [2])
C0808070 (UMLS CUI [1,2])
C0439565 (UMLS CUI [2])
Item
12-Lead ECG - Planned Relative Time (Pre-Dose)
integer
C0430456 (UMLS CUI [1])
C0439564 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0439565 (UMLS CUI [3])
C0439564 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0439565 (UMLS CUI [3])
Code List
12-Lead ECG - Planned Relative Time (Pre-Dose)
CL Item
Pre-Dose (1)
Start Time of ECG (Pre-Dose)
Item
Start Time of ECG (Pre-Dose)
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C0439565 (UMLS CUI [2])
C1301880 (UMLS CUI [1,2])
C0439565 (UMLS CUI [2])
12-Lead ECG - Ventricular Rate (Pre-Dose)
Item
12-Lead ECG - Ventricular Rate (Pre-Dose)
integer
C0430456 (UMLS CUI [1,1])
C2189285 (UMLS CUI [1,2])
C0439565 (UMLS CUI [2])
C2189285 (UMLS CUI [1,2])
C0439565 (UMLS CUI [2])
12-Lead ECG - PR Interval (Pre-Dose)
Item
12-Lead ECG - PR Interval (Pre-Dose)
integer
C0430456 (UMLS CUI [1,1])
C0429087 (UMLS CUI [1,2])
C0439565 (UMLS CUI [2])
C0429087 (UMLS CUI [1,2])
C0439565 (UMLS CUI [2])
12-Lead ECG - QRS Duration (Pre-Dose)
Item
12-Lead ECG - QRS Duration (Pre-Dose)
integer
C0430456 (UMLS CUI [1,1])
C0429025 (UMLS CUI [1,2])
C0439565 (UMLS CUI [2])
C0429025 (UMLS CUI [1,2])
C0439565 (UMLS CUI [2])
12-Lead ECG - Uncorrected QT Interval (Pre-Dose)
Item
12-Lead ECG - Uncorrected QT Interval (Pre-Dose)
integer
C0430456 (UMLS CUI [1,1])
C1287082 (UMLS CUI [1,2])
C0439565 (UMLS CUI [2])
C1287082 (UMLS CUI [1,2])
C0439565 (UMLS CUI [2])
12-Lead ECG - QTc Interval (Pre-Dose)
Item
12-Lead ECG - QTc Interval (Pre-Dose)
integer
C0430456 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
C0439565 (UMLS CUI [2])
C0855331 (UMLS CUI [1,2])
C0439565 (UMLS CUI [2])
Item
12-Lead ECG - Result (Pre-Dose)
integer
C0430456 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0439565 (UMLS CUI [2])
C1274040 (UMLS CUI [1,2])
C0439565 (UMLS CUI [2])
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal - clinically significant (3)
CL Item
No result (not available) (4)
Item Group
12-Lead ECG Abnormalities
C0430456 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C1704258 (UMLS CUI-2)
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Time of ECG
Item
Time of ECG
time
C0040223 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
C0013798 (UMLS CUI [1,2])
Item Group
12-Lead ECG Abnormalities
C0430456 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C1704258 (UMLS CUI-2)
CL Item
Sinus bradycardia (A1)
CL Item
Sinus bradycardia (heart rate 40 - 50 beats/min) (A21)
CL Item
Sinus bradycardia (heart rate 30 - 39 beats/min) (A22)
CL Item
Sinus bradycardia (heart rate <30 beats/min) (A23)
CL Item
Sinus pause (A3)
CL Item
Sinus tachycardia (heart rate >100 beats/min) (A2)
CL Item
Ectopic supraventricular beats (A4)
CL Item
Ectopic supraventricular rhythm (A20)
CL Item
Wandering atrial pacemaker (A17)
CL Item
Multifocal tachycardia (Wandering atrial pacemaker with heart rate >100 beats/min) (A26)
CL Item
Supraventricular tachycardia (heart rate >100 beats/min) (A6)
CL Item
Atrial flutter (A7)
CL Item
Atrial fibrillation (A8)
CL Item
Junctional rhythm (heart rate <=100 beats/min) (A5)
CL Item
Junctional rhythm (A26)
CL Item
Junctional tachycardia (heart rate >100 beats/min) (A24)
CL Item
Ectopic ventricular beats (A9)
CL Item
Ventricular couplets (A12)
CL Item
Bigeminy (A13)
CL Item
Trigeminy (A28)
CL Item
Electrical alternans (A14)
CL Item
R on T phenomenon (A29)
CL Item
Ventricular fibrillation (A18)
CL Item
Idioventricular rhythm (heart rate <100 beats/min) (A19)
CL Item
Sustained ventricular tachycardia (A10)
CL Item
Non-sustained ventricular tachycardia (A11)
CL Item
Ventricular tachycardia (A27)
CL Item
Monomorphic ventricular tachycardia (A30)
CL Item
Torsade de Pointes (Polymorphic ventricular tachycardia with prolonged QT) (A15)
CL Item
Polymorphic (sustained and non-sustained) ventricular tachycardia (A31)
CL Item
Artificial pacemaker (A16)
CL Item
Other abnormal rhythm (A99)
Other abnormal rhythm - Comment
Item
Other abnormal rhythm - Comment
text
C0232187 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
Item
B. P-Wave and QRS Morphology
text
C2216025 (UMLS CUI [1])
C0429098 (UMLS CUI [2])
C0429098 (UMLS CUI [2])
CL Item
Left atrial abnormality (P mitrale) (B1)
CL Item
Right atrial abnormality (P pulmonale) (B2)
CL Item
Right ventricular hypertrophy (B3)
CL Item
Intraatrial conduction delay (B5)
CL Item
Increased voltage consistent with left ventricular hypertrophy (D14)
CL Item
Other morphology (B99)
Other P-Wave and QRS Morphology - Comment
Item
Other P-Wave and QRS Morphology - Comment
text
C2216025 (UMLS CUI [1])
C0429098 (UMLS CUI [2])
C0205394 (UMLS CUI [3])
C0947611 (UMLS CUI [4])
C0429098 (UMLS CUI [2])
C0205394 (UMLS CUI [3])
C0947611 (UMLS CUI [4])
CL Item
First degree AV block (PR interval >200msec) (C1)
CL Item
Second degree AV block (Mobitz type 1) (C2)
CL Item
Second degree AV block (Mobitz type 2) (C3)
CL Item
2:1 AV block (C16)
CL Item
Third degree AV block (C4)
CL Item
Left axis deviation (QRS axis more negative than -30°) (C5)
CL Item
Right axis deviation (QRS axis more positive than +110°) (C6)
CL Item
Incomplete right bundle branch block (C7)
CL Item
Incomplete left bundle branch block (C13)
CL Item
Right bundle branch block (C8)
CL Item
Left anterior hemiblock (synonymous to left anterior fascicular block) (C14)
CL Item
Left posterior hemiblock (synonymous to left posterior fascicular block) (C15)
CL Item
Left bundle branch block (C9)
CL Item
Bifascicular block (C17)
CL Item
Non-specific intraventricular conduction delay (QRS >= 120msec) (C10)
CL Item
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine) (C11)
CL Item
QT/QTc prolongation >= 500 ms (C12)
CL Item
AV dissociation (C18)
CL Item
Other conduction (C99)
Other Conduction - Comment
Item
Other Conduction - Comment
text
C0232217 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
CL Item
Myocaridal infarction, old (D1)
CL Item
Myocardial infarction, anterior (D2)
CL Item
Myocardial infarction, lateral (D3)
CL Item
Myocardial infarction, posterior (D4)
CL Item
Myocardial infarction, inferior (D5)
CL Item
Myocardial infarction, septal (D6)
CL Item
Myocardial infarction, Non-Q wave (D20)
CL Item
Other myocardial infarction (D98)
Other Myocardial Infarction - Comment
Item
Other Myocardial Infarction - Comment
text
C0027051 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
Item
E. Depolarisation/ Repolarisation (QRS-T)
text
C1395184 (UMLS CUI [1,1])
C0948857 (UMLS CUI [1,2])
C0948857 (UMLS CUI [1,2])
CL Item
Non-specific ST-T changes (D7)
CL Item
J point elevation (D19)
CL Item
ST elevation (D8)
CL Item
ST elevation-pericarditis (D21)
CL Item
ST depression (D9)
CL Item
U waves abnormal (D10)
CL Item
T-wave inversion (D11)
CL Item
T wave peaked (D12)
CL Item
T waves flat (D15)
CL Item
T waves biphasic (D16)
CL Item
Notched T-waves (D18)
CL Item
Low QRS voltage (D13)
CL Item
T-wave flattening/inversion (D17)
CL Item
Other depolarisatoin/repolarisation (D99)
Other Depolarisation/ Repolarisation (QRS-T) - Comment
Item
Other Depolarisation/ Repolarisation (QRS-T) - Comment
text
C1395184 (UMLS CUI [1,1])
C0948857 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0947611 (UMLS CUI [2])
C0948857 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0947611 (UMLS CUI [2])
Item
Other abnormalities
text
C0522055 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
CL Item
Other abnormalities (E99)
Other abnormalities - Comment
Item
Other abnormalities - Comment
text
C0522055 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
Item Group
Pulmonary Function Tests (Pre-Dose)
C0024119 (UMLS CUI-1)
C0439565 (UMLS CUI-2)
C0439565 (UMLS CUI-2)
Pulmonary Function Tests - Date (Pre-Dose)
Item
Pulmonary Function Tests - Date (Pre-Dose)
date
C0024119 (UMLS CUI [1])
C0011008 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
C0011008 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
Item
Pulmonary Function Test (Pre-Dose)
integer
C0024119 (UMLS CUI [1])
C0439565 (UMLS CUI [2])
C0439565 (UMLS CUI [2])
CL Item
PEFR (1)
Item
Pulmonary Function Tests - Units (Pre-Dose)
integer
C0024119 (UMLS CUI [1])
C1519795 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
C1519795 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
CL Item
L (1)
Item
Pulmonary Function Tests - Planned Relative Time (Pre-Dose)
integer
C0439564 (UMLS CUI [1])
C0024119 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
C0024119 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
Code List
Pulmonary Function Tests - Planned Relative Time (Pre-Dose)
CL Item
Pre-Dose (1)
Pulmonary Function Tests - Actual Time of First Reading (Pre-Dose)
Item
Pulmonary Function Tests - Actual Time of First Reading (Pre-Dose)
time
C0024119 (UMLS CUI [1])
C0040223 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
C0040223 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
Pulmonary Function Tests - Reading 1 (Pre-Dose)
Item
Pulmonary Function Tests - Reading 1 (Pre-Dose)
float
C0024119 (UMLS CUI [1])
C0243095 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
C0243095 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
Pulmonary Function Tests - Reading 2 (Pre-Dose)
Item
Pulmonary Function Tests - Reading 2 (Pre-Dose)
float
C0024119 (UMLS CUI [1])
C0243095 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
C0243095 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
Pulmonary Function Tests - Reading 3 (Pre-Dose)
Item
Pulmonary Function Tests - Reading 3 (Pre-Dose)
float
C0024119 (UMLS CUI [1])
C0243095 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
C0243095 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
Item Group
Pharmacodynamics - Blood Sample (Pre-Dose)
C0851347 (UMLS CUI-1)
C0178913 (UMLS CUI-3)
C0439565 (UMLS CUI-5)
C0178913 (UMLS CUI-3)
C0439565 (UMLS CUI-5)
Pharmacodynamics - Planned Relative Time (Pre-Dose)
Item
Pharmacodynamics - Planned Relative Time (Pre-Dose)
text
C0851347 (UMLS CUI [1])
C0439564 (UMLS CUI [2])
C1301732 (UMLS CUI [3])
C0439565 (UMLS CUI [4])
C0439564 (UMLS CUI [2])
C1301732 (UMLS CUI [3])
C0439565 (UMLS CUI [4])
Pharmacodynamics - Date sample taken (Pre-Dose)
Item
Pharmacodynamics - Date sample taken (Pre-Dose)
date
C0851347 (UMLS CUI [1])
C1302413 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
C1302413 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
Pharmacodynamics - Actual Time (Pre-Dose)
Item
Pharmacodynamics - Actual Time (Pre-Dose)
time
C0851347 (UMLS CUI [1])
C0040223 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
C0040223 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
Item
Pharmacodynamics - Sample Number (Pre-Dose)
integer
C0851347 (UMLS CUI [1])
C1299222 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
C1299222 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
CL Item
BLD001 (1)
Item Group
Local Laboratory - Clinical Chemistry
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
C0008000 (UMLS CUI-2)
Date and time sample taken (Clinical Chemistry)
Item
Date and time sample taken (Clinical Chemistry)
datetime
C0008000 (UMLS CUI [1])
C0200345 (UMLS CUI [2])
C1264639 (UMLS CUI [3])
C0200345 (UMLS CUI [2])
C1264639 (UMLS CUI [3])
Item Group
Local Laboratory - Clinical Chemistry
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
C0008000 (UMLS CUI-2)
CL Item
Sodium (1)
CL Item
Potassium (2)
CL Item
Chloride (3)
CL Item
Bicarbonate (4)
CL Item
Urea (5)
CL Item
Creatinine (6)
CL Item
Glucose (7)
CL Item
Calcium (8)
CL Item
Phosphate (9)
CL Item
Uric Acid (10)
CL Item
Total Bilirubin (11)
CL Item
Alkaline Phosphatase (12)
CL Item
Gamma GT (13)
CL Item
Aspartate Transferase (AST) (14)
CL Item
Alanine Transferase (ALT) (15)
CL Item
Total Protein (16)
CL Item
Albumin (17)
CL Item
Globulin (18)
Clinical Chemistry Test Result
Item
Clinical Chemistry Test Result
text
C0008000 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
Item Group
Local Laboratory - Haematology
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
C0474523 (UMLS CUI-2)
Date and time sample taken (Haematology)
Item
Date and time sample taken (Haematology)
datetime
C0018941 (UMLS CUI [1])
C0870078 (UMLS CUI [2])
C1264639 (UMLS CUI [3])
C0870078 (UMLS CUI [2])
C1264639 (UMLS CUI [3])
Item Group
Local Laboratory - Haematology
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
C0474523 (UMLS CUI-2)
CL Item
Haemoglobin (1)
CL Item
Red blood Cells (2)
CL Item
Hematocrit (3)
CL Item
MCV (4)
CL Item
MCH (5)
CL Item
MCHC (6)
CL Item
White Blood Cells (7)
CL Item
Neutrophils (8)
CL Item
Lymphocytes (9)
CL Item
Monocytes (10)
CL Item
Eosinophils (11)
CL Item
Basophils (12)
CL Item
Platelets (13)
Haematologic Test Result
Item
Haematologic Test Result
text
C0018941 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
Date and time sample taken (Urinalysis)
Item
Date and time sample taken (Urinalysis)
datetime
C0042014 (UMLS CUI [1])
C0200345 (UMLS CUI [2,1])
C1264639 (UMLS CUI [2,2])
C0200345 (UMLS CUI [2,1])
C1264639 (UMLS CUI [2,2])
CL Item
Negative (NEG)
CL Item
Positive (If positive, record results of individual tests) (POS)
CL Item
No result (NR)
CL Item
Leucocyte Esterase (1)
CL Item
Nitrite (2)
CL Item
Urobilinogen (3)
CL Item
Protein (4)
CL Item
Urine pH (5)
CL Item
Blood (6)
CL Item
Specific Gravity (7)
CL Item
Ketones (8)
CL Item
Bilirubin (9)
CL Item
Glucose (10)
Item
Urinalysis Test Result
text
C0042014 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
CL Item
non or negative (NEG)
CL Item
trace (TRA)
CL Item
+ or 1+ (1+)
CL Item
++ or 2+ (2+)
CL Item
+++ or 3+ (3+)
CL Item
++++ or 4+ (4)
CL Item
+++++ or 5+ (5)
Was sedimentary microscopy performed?
Item
Was sedimentary microscopy performed?
boolean
C0430397 (UMLS CUI [1,1])
C2700128 (UMLS CUI [1,2])
C2700128 (UMLS CUI [1,2])
CL Item
WBC (1)
CL Item
RBC (2)
CL Item
Hyaline casts (3)
CL Item
Granular casts (4)
CL Item
Cellular casts (5)
Urinalysis Microscopy Test Result
Item
Urinalysis Microscopy Test Result
text
C0430397 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
Record randomisation number
Item
Record randomisation number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])