ID

40945

Beschreibung

The primary focus of this first time in human (FTIH) study was to evaluate the safety and tolerability of GSK1292263 and to estimate GSK1292263 pharmacokinetic (PK) parameters and pharmacodynamic (PD) effects in healthy volunteers. Subject: FTIH, oral, safety, tolerability, pharmacokinetics, glucose, pharmacodynamics, male, female, gastric emptying Indication Studied: Type 2 Diabetes Mellitus Study ID: 111596 Clinical Study ID: 111596 Study Title: A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00783549 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1292263, Sitagliptin Trade Name: N/A Study Indication: Dyslipidaemias

Stichworte

Versionen (2)
  1. 21.04.20 21.04.20 -
  2. 07.06.20 07.06.20 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

7. Juni 2020

DOI

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Lizenz

Creative Commons BY-NC 4.0
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A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin

Englisch

Non-Serious Adverse Events - Repeating Form, Logs/Repeats 2-RF-DF

1 Formulare  
Non-Serious Adverse Events
Beschreibung

Non-Serious Adverse Events

Alias
UMLS CUI-1
C1518404
Sequence number
Beschreibung

Sequence number

Datentyp

integer

Alias
UMLS CUI [1]
C2348184
Event: Diagnosis only (if known) Otherwise Sign/Symptom
Beschreibung

Event

Datentyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0011900
UMLS CUI [2,1]
C1518404
UMLS CUI [2,2]
C3540840
Modified term
Beschreibung

Modified term

Datentyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2826798
Start date and time
Beschreibung

Start time is optional

Datentyp

datetime

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0808070
UMLS CUI [1,3]
C1301880
Outcome
Beschreibung

Provide End Date and Time in the next question if indicated

Datentyp

integer

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1518404
Outcome End Date and Time
Beschreibung

concerns the previous question End Time is optional

Datentyp

datetime

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C2826793
Frequency
Beschreibung

this item is optional

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0439603
Maximum Intensity
Beschreibung

Optional item: this item may be hidden if either the "Maximum Grade" or "Maximum Grade or Intensity" item has been used. Grade 5 is optional.

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0806909
Maximum Grade
Beschreibung

Optional item: this item may be hidden if either the "Maximum Intensity" or "Maximum Grade or Intensity" item has been used. Grade 5 is optional.

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0806909
Maximum Grade or Intensity
Beschreibung

Optional item: this item may be hidden if either the "Maximum Intensity" or "Maximum Grade" item has been used. Grade 5 is optional.

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0806909
UMLS CUI [2,1]
C1518404
UMLS CUI [2,2]
C0518690
UMLS CUI [2,3]
C0806909
Action Taken with Investigational Product(s) as a Result of the AE
Beschreibung

AE: adverse event

Datentyp

integer

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1518404
Did the subject withdraw from study as a result of this AE?
Beschreibung

AE: adverse event

Datentyp

integer

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C1518404
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beschreibung

Possibility AE caused by investigational product

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0085978
UMLS CUI [1,4]
C1705910
Duration of AE if < 24 hours
Beschreibung

AE: adverse event in hours and minutes If AE start and end time are used this item must be hidden.

Datentyp

text

Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C1518404
Time to Onset Since Last Dose
Beschreibung

in hours and minutes This item is optional

Datentyp

text

Alias
UMLS CUI [1,1]
C0449244
UMLS CUI [1,2]
C1762893
UMLS CUI [1,3]
C1518404
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Ähnliche Modelle

Non-Serious Adverse Events - Repeating Form, Logs/Repeats 2-RF-DF

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Non-Serious Adverse Events
C1518404 (UMLS CUI-1)
Sequence number
Item
Sequence number
integer
C2348184 (UMLS CUI [1])
Event
Item
Event: Diagnosis only (if known) Otherwise Sign/Symptom
text
C1518404 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C3540840 (UMLS CUI [2,2])
Modified term
Item
Modified term
text
C1518404 (UMLS CUI [1,1])
C2826798 (UMLS CUI [1,2])
Start date and time
Item
Start date and time
datetime
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Item
integer
C1705586 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Outcome
Code List
Outcome
CL Item
Recovered/Resolved (provide End Date and Time in the next question) (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae (provide End Date and Time in the next question) (4)
Outcome End Date and Time
Item
Outcome End Date and Time
datetime
C1705586 (UMLS CUI [1,1])
C2826793 (UMLS CUI [1,2])
Item
Frequency
integer
C1518404 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Frequency
Code List
Frequency
CL Item
Single episode (1)
CL Item
Intermittent (2)
Item
Maximum Intensity
integer
C1518404 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Maximum Intensity
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Item
Maximum Grade
integer
C1518404 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Maximum Grade
Code List
Maximum Grade
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
CL Item
Not applicable (6)
Item
Maximum Grade or Intensity
integer
C1518404 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C1518404 (UMLS CUI [2,1])
C0518690 (UMLS CUI [2,2])
C0806909 (UMLS CUI [2,3])
Maximum Grade or Intensity
Code List
Maximum Grade or Intensity
CL Item
Mild or Grade 1 (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Severe or Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
CL Item
Not applicable (6)
Item
Action Taken with Investigational Product(s) as a Result of the AE
integer
C1704758 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Action Taken
Code List
Action Taken with Investigational Product(s) as a Result of the AE
CL Item
Investigational product(s) 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 (6)
Item
Did the subject withdraw from study as a result of this AE?
integer
C1710677 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Withdrawal upon AE
Code List
Did the subject withdraw from study as a result of this AE?
CL Item
Yes (1)
CL Item
No (2)
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
integer
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
C1705910 (UMLS CUI [1,4])
Withdrawal upon AE
Code List
Is there a reasonable possibility that the AE may have been caused by the investigational product?
CL Item
Yes (1)
CL Item
No (2)
Duration if AE < 24 hours
Item
Duration of AE if < 24 hours
text
C0449238 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Time to Onset Since Last Dose
Item
Time to Onset Since Last Dose
text
C0449244 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
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