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Informatie:
Fout:
ID
38912
Beschrijving
Study ID: 110951 Clinical Study ID: 110951 Study Title: A two-part, randomised, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single doses of intravenously infused GSK1995057 in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01476046 See https://clinicaltrials.gov/ct2/show/NCT01476046 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: N/A, Placebo Trade Name: N/A Study Indication: Respiratory Disorders This phase I trial primarily studies the safety and tolerability of ascending single intravenous doses of the selective TNFR1 antagonist GSK1995057 in healthy volunteers, and secondly explores the drug's pharmacodynamics, pharmacokinetics, concentration in lung epithelial lining fluid as well as its effect on immune system markers. The drug is hypothesized to be useful for Acute Lung Injury. The single-centre study consists of two parts A and B with seven cohorts/ten subcohorts in total. Part A includes ascending doses of the investigational product given to subjects negative or positive for pre-existing human anti-heavy chain variable domain (HAVH) antibodies (Cohorts 1 to 3 with Subcohorts 1a, 2a and 3a negative for HAVH and 1b, 2b, 3b positive for HAVH). Part B includes only subjects negative for HAVH, with ascending doses given to Cohorts 4 to 6. Cohort 7 receives the same dose as Cohort 6, but whereas the other Cohorts are single-blinded, Cohort 7 is open-label and additionally receives a bronchoalveolar lavage (BAL). The study consists of a Screening Visit (up to 56 days before Day 1, the day of the drug administration), Visits on Day -1, 1, 2, 3, 5, 7, 14, 28 and Follow-Up Visits on Day 57 and 85. This form is to be filled in whenever a Holter ECG or Telemetry reading is abnormal.
Link
https://clinicaltrials.gov/ct2/show/NCT01476046
Trefwoorden
Versies (4)
- 25-10-19 25-10-19 -
- 12-11-19 12-11-19 - Sarah Riepenhausen
- 12-11-19 12-11-19 - Sarah Riepenhausen
- 20-09-21 20-09-21 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
12 november 2019
DOI
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Licentie
Creative Commons BY-NC 3.0
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Phase I Trial of Intravenous TNFR1 Antagonist GSK1995057 in Healthy Subjects - NCT01476046
Unscheduled Holter/Telemetry Abnormalities
- StudyEvent: ODM
Similar models
Unscheduled Holter/Telemetry Abnormalities
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Holter/Telemetry Abnormalities Administrative Data
C1704258 (UMLS CUI-1)
C1320722 (UMLS CUI-2)
C0013801 (UMLS CUI-3)
C0039451 (UMLS CUI-4)
C1320722 (UMLS CUI-2)
C0013801 (UMLS CUI-3)
C0039451 (UMLS CUI-4)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Date/Time of Assessment
Item
Date/Time of Assessment
datetime
C2985720 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,2])
Item Group
Holter/Telemetry Abnormality
C0013801 (UMLS CUI-1)
C1832603 (UMLS CUI-2)
C0039451 (UMLS CUI-3)
C1832603 (UMLS CUI-2)
C0039451 (UMLS CUI-3)
Test Number
Item
Test Number
integer
C0600091 (UMLS CUI [1,1])
C0039593 (UMLS CUI [1,2])
C0039593 (UMLS CUI [1,2])
Test Start Date/Time
Item
Start Date and Time
datetime
C3897500 (UMLS CUI [1])
Test Stop Date/Time
Item
Stop Date and Time
datetime
C3899266 (UMLS CUI [1])
CL Item
Holter (1)
CL Item
Telemetry (2)
No abnormalities
Item
No abnormalities
boolean
C0522054 (UMLS CUI [1])
Sinus bradycardia (50-59 beats/min)
Item
Sinus bradycardia (50-59 beats/min)
boolean
C0085610 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
Sinus bradycardia (heart rate 40-49 beats/min)
Item
Sinus bradycardia (heart rate 40-49 beats/min)
boolean
C0085610 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
Sinus bradycardia (heart rate 30-39 beats/min)
Item
Sinus bradycardia (heart rate 30-39 beats/min)
boolean
C0085610 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
Sinus bradycardia (heart rate <30 beats/min)
Item
Sinus bradycardia (heart rate <30 beats/min)
boolean
C0085610 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
Sinus pause
Item
Sinus pause
boolean
C1955864 (UMLS CUI [1])
Sinus tachycardia
Item
Sinus tachycardia (heart rate> 100 beats/min)
boolean
C0039239 (UMLS CUI [1])
Ectopic supraventricular beats
Item
Ectopic supraventricular beats
boolean
C0033036 (UMLS CUI [1])
Ectopic supraventricular rhythm
Item
Ectopic supraventricular rhythm
boolean
C2348376 (UMLS CUI [1])
Wandering atrial pacemaker
Item
Wandering atrial pacemaker
boolean
C1321523 (UMLS CUI [1])
Multifocal atrial tachycardia
Item
Multifocal atrial tachycardia (wandering atrial pacemaker with heart rate > 100 beats/min)
boolean
C0221158 (UMLS CUI [1])
Non-sustained Supraventricular tachycardia
Item
Non-sustained supraventricular tachycardia (>100 beats/min, 3-30 beats)
boolean
C0039240 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
C0205374 (UMLS CUI [1,3])
C0018810 (UMLS CUI [1,2])
C0205374 (UMLS CUI [1,3])
Sustained supraventricular tachycardia
Item
Sustained supraventricular tachycardia (>100 beats/min, >30 beats)
boolean
C0039240 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
C0443318 (UMLS CUI [1,3])
C0018810 (UMLS CUI [1,2])
C0443318 (UMLS CUI [1,3])
Atrial flutter
Item
Atrial flutter
boolean
C0004239 (UMLS CUI [1])
Atrial fibrillation
Item
Atrial fibrillation
boolean
C0004238 (UMLS CUI [1])
Junctional rhythm (<=100 beats/min, defined by narrow QRS complex)
Item
Junctional rhythm (<=100 beats/min, defined by narrow QRS complex)
boolean
C0232208 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
C1287080 (UMLS CUI [1,3])
C0018810 (UMLS CUI [1,2])
C1287080 (UMLS CUI [1,3])
Junctional tachycardia
Item
Junctional tachycardia (heart rate > 100 beats/min)
boolean
C0039235 (UMLS CUI [1])
Ventricular premature depolarisation
Item
Ventricular premature depolarisation
boolean
C0151636 (UMLS CUI [1])
Ventricular couplets
Item
Ventricular couplets
boolean
C0429001 (UMLS CUI [1])
Bigeminy
Item
Bigeminy
boolean
C0262662 (UMLS CUI [1])
Trigeminy
Item
Trigeminy
boolean
C0428999 (UMLS CUI [1])
Electrical alternans
Item
Electrical alternans
boolean
C1142551 (UMLS CUI [1])
R on T phenomenon
Item
R on T phenomenon
boolean
C0877658 (UMLS CUI [1])
Ventricular fibrillation
Item
Ventricular fibrillation
boolean
C0042510 (UMLS CUI [1])
Idioventricular rhythm (<=100 beats/min, defined by wide QRS complex)
Item
Idioventricular rhythm (<=100 beats/min, defined by wide QRS complex)
boolean
C0700363 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
C1287080 (UMLS CUI [1,3])
C0018810 (UMLS CUI [1,2])
C1287080 (UMLS CUI [1,3])
Non-sustained ventricular tachycardia
Item
Non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats)
boolean
C0750194 (UMLS CUI [1])
Sustained ventricular tachycardia
Item
Sustained ventricular tachycardia (>100 beats/min, >30 beats)
boolean
C0750197 (UMLS CUI [1])
Wide QRS tachycardia
Item
Wide QRS tachycardia (diagnosis unknown)
boolean
C0344429 (UMLS CUI [1])
Monomorphic non-sustained ventricular tachycardia
Item
Monomorphic non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats)
boolean
C0344431 (UMLS CUI [1,1])
C0750194 (UMLS CUI [1,2])
C0750194 (UMLS CUI [1,2])
Monomorphic sustained ventricular tachycardia
Item
Monomorphic sustained ventricular tachycardia (>100 beats/min, >30 beats)
boolean
C0344431 (UMLS CUI [1,1])
C0750197 (UMLS CUI [1,2])
C0750197 (UMLS CUI [1,2])
Polymorphic non-sustained ventricular tachycardia
Item
Polymorphic non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats)
boolean
C0344432 (UMLS CUI [1,1])
C0750194 (UMLS CUI [1,2])
C0750194 (UMLS CUI [1,2])
Polymorphic sustained ventricular tachycardia
Item
Polymorphic sustained ventricular tachycardia (>100 beats/min, >30 beats)
boolean
C0344432 (UMLS CUI [1,1])
C0750197 (UMLS CUI [1,2])
C0750197 (UMLS CUI [1,2])
Torsades de Pointes
Item
Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT)
boolean
C0040479 (UMLS CUI [1])
Artificial Pacemaker
Item
Pacemaker
boolean
C0030163 (UMLS CUI [1])
First degree AV block
Item
First degree AV block (PR interval> 200msec)
boolean
C0085614 (UMLS CUI [1])
Short PR interval
Item
Short PR interval
boolean
C0520878 (UMLS CUI [1])
Second degree AV block (Mobitz type 1)
Item
Second degree AV block (Mobitz type 1)
boolean
C0264907 (UMLS CUI [1])
Second degree AV block (Mobitz type 2)
Item
Second degree AV block (Mobitz type 2)
boolean
C0155700 (UMLS CUI [1])
2: 1 AV block
Item
2: 1 AV block
boolean
C2346542 (UMLS CUI [1])
Third degree AV block
Item
Third degree AV block
boolean
C0151517 (UMLS CUI [1])
Left axis deviation
Item
Left axis deviation (QRS axis more negative than -30 degrees)
boolean
C0232297 (UMLS CUI [1])
Right axis deviation
Item
Right axis deviation (QRS axis more positive than +110 degrees)
boolean
C0232296 (UMLS CUI [1])
Incomplete right bundle branch block
Item
Incomplete right bundle branch block
boolean
C0262525 (UMLS CUI [1])
Incomplete left bundle branch block
Item
Incomplete left bundle branch block
boolean
C0281878 (UMLS CUI [1])
Right bundle branch block
Item
Right bundle branch block
boolean
C0085615 (UMLS CUI [1])
Left anterior hemiblock
Item
Left anterior hemiblock
boolean
C0264912 (UMLS CUI [1])
Left posterior hemiblock
Item
Left posterior hemiblock
boolean
C0264913 (UMLS CUI [1])
Left bundle branch block
Item
Left bundle branch block
boolean
C0023211 (UMLS CUI [1])
Bifascicular block
Item
Bifascicular block
boolean
C0264914 (UMLS CUI [1])
Non-specific intraventricular conduction delay
Item
Non-specific intraventricular conduction delay (QRS >= 120 msec)
boolean
C3697597 (UMLS CUI [1])
Accessory pathway in Wolff-Parkinson White/Lown-Ganong-Levine Syndrome
Item
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)
boolean
C1963785 (UMLS CUI [1,1])
C0043202 (UMLS CUI [1,2])
C1963785 (UMLS CUI [2,1])
C0024054 (UMLS CUI [2,2])
C0043202 (UMLS CUI [1,2])
C1963785 (UMLS CUI [2,1])
C0024054 (UMLS CUI [2,2])
QTc prolongation by QTc time
Item
QTc prolongation >=500msec
boolean
C0855333 (UMLS CUI [1])
C0489625 (UMLS CUI [2])
C0489625 (UMLS CUI [2])
AV dissociation
Item
AV dissociation
boolean
C0004331 (UMLS CUI [1])
Myocardial infarction, old
Item
Myocardial infarction, old
boolean
C0155668 (UMLS CUI [1])
Myocardial infarction, Non Q-wave
Item
Myocardial infarction, Non Q-wave
boolean
C0542269 (UMLS CUI [1])
Non-specific ST-T changes
Item
Non-specific ST-T changes
boolean
C1112720 (UMLS CUI [1])
J point elevation
Item
J point elevation
boolean
C2346597 (UMLS CUI [1])
ST elevation
Item
ST elevation
boolean
C0520886 (UMLS CUI [1])
ST segment abnormality
Item
ST segment abnormality
boolean
C2348120 (UMLS CUI [1])
ST depression
Item
ST depression
boolean
C0520887 (UMLS CUI [1])
U waves
Item
U waves
boolean
C0232333 (UMLS CUI [1])
T wave inversion
Item
T wave inversion
boolean
C0520888 (UMLS CUI [1])
T wave peaked
Item
T wave peaked
boolean
C0239242 (UMLS CUI [1])
T waves biphasic
Item
T waves biphasic
boolean
C2348639 (UMLS CUI [1])
T waves flat
Item
T waves flat
boolean
C2215959 (UMLS CUI [1])
Notched T-waves
Item
Notched T-waves
boolean
C2347367 (UMLS CUI [1])
Low QRS voltage
Item
Low QRS voltage
boolean
C2349945 (UMLS CUI [1])
T wave abnormality
Item
T wave abnormality
boolean
C0438167 (UMLS CUI [1])
Other abnormal rhythm
Item
Other abnormal rhythm
boolean
C0205394 (UMLS CUI [1,1])
C0199556 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
C0199556 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
Comment abnormal rhythm
Item
If other abnormal rhythm, please specify
text
C0947611 (UMLS CUI [1,1])
C0199556 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
C0199556 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
Other morphology
Item
Other morphology
boolean
C0205394 (UMLS CUI [1,1])
C0332437 (UMLS CUI [1,2])
C0332437 (UMLS CUI [1,2])
Comment other morphology
Item
If other morphology, please specify
text
C0332437 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Other conduction abnormality
Item
Other conduction abnormality
boolean
C0340494 (UMLS CUI [1])
Comment other conduction abnormality
Item
If other conduction abnormality, please specify
text
C0340494 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
Other myocardial infarction
Item
Other myocardial infarction
boolean
C0205394 (UMLS CUI [1,1])
C0027051 (UMLS CUI [1,2])
C0027051 (UMLS CUI [1,2])
Comment other myocardial infarction
Item
If other myocardial infarction, please specify
text
C0205394 (UMLS CUI [1,1])
C0027051 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C0027051 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Other depolarisation/repolarisation abnormality
Item
Other depolarisation/repolarisation abnormality
boolean
C0205394 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C2746082 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2,1])
C0948857 (UMLS CUI [2,2])
C0205161 (UMLS CUI [1,2])
C2746082 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2,1])
C0948857 (UMLS CUI [2,2])
Comment other depolarisation/repolarisation
Item
If other depolarisation/repolarisation, please specify
text
C0205394 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C2746082 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
C0205394 (UMLS CUI [2,1])
C0948857 (UMLS CUI [2,2])
C0947611 (UMLS CUI [2,3])
C0205161 (UMLS CUI [1,2])
C2746082 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
C0205394 (UMLS CUI [2,1])
C0948857 (UMLS CUI [2,2])
C0947611 (UMLS CUI [2,3])
Other abnormality/Cardiologist comments
Item
Other abnormality/Cardiologist comments
boolean
C0522055 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0175906 (UMLS CUI [2,1])
C0947611 (UMLS CUI [2,2])
C0205394 (UMLS CUI [1,2])
C0175906 (UMLS CUI [2,1])
C0947611 (UMLS CUI [2,2])
Other abnormality/Cardiologist comments
Item
Other abnormality/Cardiologist comments
text
C0522055 (UMLS CUI [1,1])
C3845569 (UMLS CUI [1,2])
C0175906 (UMLS CUI [2,1])
C0947611 (UMLS CUI [2,2])
C3845569 (UMLS CUI [1,2])
C0175906 (UMLS CUI [2,1])
C0947611 (UMLS CUI [2,2])