Informatie:
Fout:
ID
40313
Beschrijving
Study ID: 111314 Clinical Study ID: 111314 Study Title: A first-time-in-human, three-part, placebo-controlled, dose escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of GSK1521498 in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00857883 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1521498 or placebo Study Indication: Obesity
Trefwoorden
Versies (2)
- 06-04-20 06-04-20 -
- 06-04-20 06-04-20 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
6 april 2020
DOI
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Licentie
Creative Commons BY-NC 4.0
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Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK1521498 in healthy subjects NCT00857883
Adverse Events; Demography; Height Weight; ECG
- StudyEvent: ODM
Similar models
Adverse Events; Demography; Height Weight; ECG
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Study
Item
Study
text
C2603343 (UMLS CUI [1])
Subject
Item
Subject
text
C0681850 (UMLS CUI [1])
Collected by
Item
Collected by
text
C3244127 (UMLS CUI [1])
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Study Phase
Item
Study Phase
text
C0205390 (UMLS CUI [1,1])
C2603343 (UMLS CUI [1,2])
C2603343 (UMLS CUI [1,2])
Session
Item
Session
text
C1883017 (UMLS CUI [1])
Investigator Review
Item
Investigator Review
text
C0035173 (UMLS CUI [1,1])
C3166277 (UMLS CUI [1,2])
C3166277 (UMLS CUI [1,2])
Verbatim AE
Item
Verbatim AE
text
C2699044 (UMLS CUI [1])
AE - Secondary classification
Item
AE - Secondary classification
text
C0877248 (UMLS CUI [1,1])
C1140263 (UMLS CUI [1,2])
C1140263 (UMLS CUI [1,2])
AE - MedDRA Code
Item
AE - MedDRA Code
text
C0877248 (UMLS CUI [1,1])
C3898442 (UMLS CUI [1,2])
C3898442 (UMLS CUI [1,2])
CL Item
No (N)
CL Item
Unknown (U)
CL Item
Not applicable (X)
CL Item
Yes (Y)
CL Item
Fatal (1)
CL Item
Life threatening (2)
CL Item
Disabling/Incapacitating (3)
CL Item
Results in hospitalisation (4)
CL Item
Prolongs a hospital stay (5)
CL Item
Associated with an abnormality (6)
CL Item
Associated with cancer (7)
CL Item
Associated with overdose (8)
CL Item
Other (9)
AE - Start Date
Item
AE - Start Date
date
C2697888 (UMLS CUI [1])
AE - Start time
Item
AE - Start time
time
C2697889 (UMLS CUI [1])
AE - Continuing
Item
AE - Continuing
boolean
C2826663 (UMLS CUI [1])
AE - Stop Date
Item
AE - Stop Date
date
C0806020 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
AE - Stop time
Item
AE - Stop time
time
C2826658 (UMLS CUI [1])
AE - Number of episodes
Item
AE - Number of episodes
integer
C0877248 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
C4086638 (UMLS CUI [1,2])
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not Applicable (X)
CL Item
Inv product withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (X)
CL Item
No (N)
CL Item
Unknown (U)
CL Item
Not applicable (X)
CL Item
Yes (Y)
CL Item
Resolved (1)
CL Item
Ongoing (2)
CL Item
Died (3)
Item
AE - Experience Course
text
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
C0750729 (UMLS CUI [1,2])
CL Item
Intermittent (1)
CL Item
Constant (2)
AE - Intensity (maximum)
Item
AE - Intensity (maximum)
text
C0518690 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0877248 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
AE - Action with respect to Investigational Drug
Item
AE - Action with respect to Investigational Drug
text
C2826626 (UMLS CUI [1])
AE - Total Number episodes
Item
AE - Total Number episodes
integer
C0877248 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
C4086638 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
AE - Is there a reasonable possibility that the AE may have been caused by the Investigational Product?
Item
AE - Is there a reasonable possibility that the AE may have been caused by the Investigational Product?
boolean
C0877248 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
AE - Corrective Therapy
Item
AE - Corrective Therapy
text
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
Item
Was patient withdrawn due to this AE?
text
C0422727 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
CL Item
No (N)
CL Item
Unknown (U)
CL Item
Not applicable (X)
CL Item
Yes (Y)
SAE - Collected
Item
SAE - Collected
text
C1519255 (UMLS CUI [1,1])
C1516698 (UMLS CUI [1,2])
C1516698 (UMLS CUI [1,2])
Item
1. Specify reasons for considering this is a serious AE
integer
C3828190 (UMLS CUI [1])
Code List
1. Specify reasons for considering this is a serious AE
CL Item
FATAL (1)
CL Item
Is life-threatening (2)
CL Item
Results in disability/incapacity (3)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (4)
CL Item
Congenital abnormality/birth defect (5)
CL Item
Other (6)
2. Did the SAE abate
Item
2. Did the SAE abate
boolean
C1519255 (UMLS CUI [1,1])
C3853704 (UMLS CUI [1,2])
C3853704 (UMLS CUI [1,2])
3. If study medication was interrupted, stopped, or dose reduced: Was study medication reintroduced
Item
3. If study medication was interrupted, stopped, or dose reduced: Was study medication reintroduced
boolean
C0420247 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0376495 (UMLS CUI [2])
C0304229 (UMLS CUI [1,2])
C0376495 (UMLS CUI [2])
3. If study medication was reintroduced, did SAE recur?
Item
3. If study medication was reintroduced, did SAE recur?
boolean
C0304229 (UMLS CUI [1,1])
C0376495 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0034897 (UMLS CUI [2,2])
C0376495 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0034897 (UMLS CUI [2,2])
Item
4. If Relationship to Investigational drug was NOT RELATED or UNLIKELY choose an assessment. The SAE is probably associated with
integer
C1519255 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Code List
4. If Relationship to Investigational drug was NOT RELATED or UNLIKELY choose an assessment. The SAE is probably associated with
CL Item
Disease under study (1)
CL Item
Medical condition(s) (2)
CL Item
Lack of efficacy (3)
CL Item
Withdrawal of investigative product (4)
CL Item
Concomitant medication(s) (5)
CL Item
Activity related to study participation (6)
CL Item
Other (7)
5. Please provide details supporting the selection made in item 4
Item
5. Please provide details supporting the selection made in item 4
text
C1522508 (UMLS CUI [1])
Remarks
Item
Remarks
text
C0947611 (UMLS CUI [1])
Item
Was the randomization code broken at the investigational site
text
C0034656 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,2])
Code List
Was the randomization code broken at the investigational site
CL Item
Yes (Y)
CL Item
No (N)
CL Item
N/A (N/A)
Randomization/study medication
Item
Randomization/study medication
text
C0034656 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
Date of Death
Item
Date of Death
date
C1148348 (UMLS CUI [1])
Certified cause of Death
Item
Certified cause of Death
text
C0007465 (UMLS CUI [1])
Was a post mortem performed?
Item
Was a post mortem performed?
boolean
C0004398 (UMLS CUI [1])
If post mortem performed please summarize findings (include diagnosis)
Item
If post mortem performed please summarize findings (include diagnosis)
text
C0004398 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
C0243095 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
SAE Report signed by:
Item
SAE Report signed by:
text
C1519255 (UMLS CUI [1,1])
C0684224 (UMLS CUI [1,2])
C1519316 (UMLS CUI [1,3])
C0684224 (UMLS CUI [1,2])
C1519316 (UMLS CUI [1,3])
Demography - Date
Item
Demography - Date
date
C0011298 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
C2985720 (UMLS CUI [1,2])
Demography - Time
Item
Demography - Time
time
C0011298 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
Demography - Day
Item
Demography - Day
text
C0011298 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,2])
Demography - Hour
Item
Demography - Hour
integer
C0011298 (UMLS CUI [1,1])
C0439227 (UMLS CUI [1,2])
C0439227 (UMLS CUI [1,2])
Demography - Min
Item
Demography - Min
integer
C0011298 (UMLS CUI [1,1])
C0439232 (UMLS CUI [1,2])
C0439232 (UMLS CUI [1,2])
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
CL Item
Female (F)
CL Item
Male (M)
CL Item
African American/African Heritage (11)
CL Item
American Indian or Alaskan Native (12)
CL Item
Asian - Central/South Asian Heritage (13)
CL Item
Asian - East Asian Heritage (14)
CL Item
Asian - Japanese Heritage (15)
CL Item
Asian - South East Asian Heritage (16)
CL Item
Native Hawaiian or Other Pacific Islander (17)
CL Item
White - Arabic/North African Heritage (18)
CL Item
White - White/Caucasian/European Heritage (19)
CL Item
Mixed race (99)
CL Item
Asian (01)
CL Item
European african (02)
CL Item
Hispanic (03)
CL Item
Turkish/Cypriot (04)
CL Item
Patient (P)
CL Item
Volunteer (V)
CL Item
ACS (A)
CL Item
CV History (V)
CL Item
Healthy Elderly (E)
CL Item
FEP-R (G)
CL Item
FEP (F)
CL Item
Stimulant Dependent (S)
CL Item
OCD (O)
CL Item
Renal Impaired (R)
CL Item
Migraineur (M)
CL Item
Normal (N)
CL Item
Type II Diabetes (D)
CL Item
Osteoartgritis (Y)
CL Item
COPD (C)
CL Item
Asthmatic (X)
Height Weight - Physical Date
Item
Height Weight - Physical Date
date
C0005890 (UMLS CUI [1,1])
C0005910 (UMLS CUI [1,2])
C2826643 (UMLS CUI [1,3])
C0005910 (UMLS CUI [1,2])
C2826643 (UMLS CUI [1,3])
Height Weight - Time
Item
Height Weight - Time
time
C0005890 (UMLS CUI [1,1])
C0005910 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0005910 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Height Weight - Day
Item
Height Weight - Day
text
C0005890 (UMLS CUI [1,1])
C0005910 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
C0005910 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
Height Weight - Hour
Item
Height Weight - Hour
integer
C0005890 (UMLS CUI [1,1])
C0005910 (UMLS CUI [1,2])
C0439227 (UMLS CUI [1,3])
C0005910 (UMLS CUI [1,2])
C0439227 (UMLS CUI [1,3])
Height Weight - Min
Item
Height Weight - Min
integer
C0005890 (UMLS CUI [1,1])
C0005910 (UMLS CUI [1,2])
C0439232 (UMLS CUI [1,3])
C0005910 (UMLS CUI [1,2])
C0439232 (UMLS CUI [1,3])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
ECG Date
Item
ECG Date
date
C2826640 (UMLS CUI [1])
ECG Time
Item
ECG Time
time
C0040223 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
C0013798 (UMLS CUI [1,2])
ECG Day
Item
ECG Day
text
C1623258 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,2])
ECG Hour
Item
ECG Hour
integer
C1623258 (UMLS CUI [1,1])
C0439227 (UMLS CUI [1,2])
C0439227 (UMLS CUI [1,2])
ECG Min
Item
ECG Min
integer
C1623258 (UMLS CUI [1,1])
C0439232 (UMLS CUI [1,2])
C0439232 (UMLS CUI [1,2])
CL Item
No (N)
CL Item
Unknown (U)
CL Item
Not applicable (X)
CL Item
Yes (Y)
Ventricular Rate
Item
Ventricular Rate
integer
C2189285 (UMLS CUI [1])
PR Interval
Item
PR Interval
integer
C0429087 (UMLS CUI [1])
QRS Interval
Item
QRS Interval
integer
C0520880 (UMLS CUI [1])
QT Interval
Item
QT Interval
integer
C1287082 (UMLS CUI [1])
QTc Interval
Item
QTc Interval
integer
C0489625 (UMLS CUI [1])
ECG Interpretation
Item
ECG Interpretation
text
C1623258 (UMLS CUI [1,1])
C0459471 (UMLS CUI [1,2])
C0459471 (UMLS CUI [1,2])
CL Item
Sinus Bradycardia (A1)
CL Item
Sustained ventricular tachycardia (A10)
CL Item
Non-sustained ventricular tachycardia (A11)
CL Item
Ventricular couplets (A12)
CL Item
Bigeminy (A13)
CL Item
Electrical alternans (A14)
CL Item
Torsade de Pointes (A15)
CL Item
Pacemaker (A16)
CL Item
Wandering atrial pacemaker (A17)
CL Item
Ventricullar Fibrillation (A18)
CL Item
Idioventricular rhythm - heart rate < 100 beats/min (A19)
CL Item
Sinus Tachycardia (A2)
CL Item
Ectopic supraventricular rhythm (A20)
CL Item
Sinus bradycardia (heart rate 40-50 beats/min) (A21)
CL Item
Sinus bradycardia (heart rate 30-39 beats/min) (A23)
CL Item
Junctional tachycardia (heart rate > 100 beats/min) (A24)
CL Item
Junctional rhythm (A25)
CL Item
Multifocal atrial tachycardia (wandering atrial pacemaker w/rate > 100 beats/min) (A26)
CL Item
Ventricular tachycardia (A27)
CL Item
Trigemini (A28)
CL Item
R on T phenomenon (A29)
CL Item
Sinus pause (A3)
CL Item
Monomorphic ventricular tachycardia (A30)
CL Item
Polymorphic ventricular tachycardia (sustained and non sustained) (A31)
CL Item
Ectopic supraventricular beats (A4)
CL Item
Junctional rhythm (<=100/min) (A5)
CL Item
Supraventricular tachycardia (.100/min) (A6)
CL Item
Atrial flutter (A7)
CL Item
Atrial fibrillation (A8)
CL Item
Ectopic ventricular beats (A9)
CL Item
Other abnormal rhythm (A99)
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
Left ventricular hypertrophy (B6)
CL Item
Other morphology (B99)
CL Item
First degree AV block (PR interval>200 msec) (C1)
CL Item
Non-specific intraventicular conduction delay (QRS >=120 msec) (C10)
CL Item
Accessory pathway (Wolff-Parkinson-White, Lown-Ganong-Levine) (C11)
CL Item
QT/QTc prolongation >= 500msec (C12)
CL Item
Incomplete left brundle branch block (C13)
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
2:1 AV block (C16)
CL Item
Biphascicular block (C17)
CL Item
AV dissociation (C18)
CL Item
Prolonged QT interval (C19)
CL Item
Second degree AV block (Mobitz type 1) (C2)
CL Item
Second degree AV block (Mobitz type 2) (C3)
CL Item
Third degree AV block (C4)
CL Item
Left Axis deviation (QRS more negative than -30degrees) (C5)
CL Item
Left Axis deviation (QRS more positive than +110degrees) (C6)
CL Item
Incomplete right bundle branch block (C7)
CL Item
Right bundle branch block (C8)
CL Item
Left bundle branch block (C9)
CL Item
Other conduction (C99)
CL Item
Myocardial infarction, old (D1)
CL Item
U waves (D10)
CL Item
T wave inversion (D11)
CL Item
T wave peaked (D12)
CL Item
Low QRS voltage (D13)
CL Item
Increased voltage consistent with left ventricular hypertrophy (D14)
CL Item
T waves flat (D15)
CL Item
T waves biphasic (D16)
CL Item
T wave flattening inversion (D17)
CL Item
Notched T waves (D18)
CL Item
J point elevation (D19)
CL Item
Myocardial infarction, anterior (D2)
CL Item
Myocardial infarction, non Q-wave (D20)
CL Item
ST-elevation - percarditis (D21)
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
Non-specific ST-T changes (D7)
CL Item
ST elevation (D8)
CL Item
ST depression (D9)
CL Item
ST segment abnormality (D96)
CL Item
T wave abnormality (D97)
CL Item
Other myocardial infarction (D98)
CL Item
Other depolarisation/repolarisation (D99)
CL Item
Other (E99)
ECG Holter Day
Item
ECG Holter Day
text
C0013801 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,2])
ECG Holter Hour
Item
ECG Holter Hour
integer
C0013801 (UMLS CUI [1,1])
C0439227 (UMLS CUI [1,2])
C0439227 (UMLS CUI [1,2])
ECG Holter Min
Item
ECG Holter Min
integer
C0013801 (UMLS CUI [1,1])
C0439232 (UMLS CUI [1,2])
C0439232 (UMLS CUI [1,2])
ECG Recording Start Date
Item
ECG Recording Start Date
date
C0013801 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
ECG Holter Start time
Item
ECG Holter Start time
time
C0013801 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
ECG Recording Stop Date
Item
ECG Recording Stop Date
date
C0013801 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
ECG Holter Stop Time
Item
ECG Holter Stop Time
time
C0013801 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
Item
ECG Holter - Type of Monitoring
integer
C0013801 (UMLS CUI [1,1])
C1283169 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
C1283169 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
CL Item
12 Lead (1)
CL Item
Lead II (2)
CL Item
Holter (unspecified) (3)
CL Item
Holter (24 Hour) (4)
CL Item
Holter (48 Hour) (5)
CL Item
Holter (72 Hour) (6)
CL Item
Holter (12 Hour) (7)
CL Item
No (N)
CL Item
Unknown (U)
CL Item
Not applicable (X)
CL Item
Yes (Y)
Item
ECG Holter - Analysis Details
text
C0013801 (UMLS CUI [1,1])
C0936012 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
C0936012 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
CL Item
ST Segment Elevation (2)
CL Item
ST Segment Depression (3)
CL Item
T Wave Flattening (4)
CL Item
T Wave Inversion (6)
CL Item
Normal (N)
CL Item
Other (O)
CL Item
Prolonged QT Interval (P)
CL Item
Clinically significant Abnormality (S)