ID

32903

Beskrivning

Study ID: 107085 Clinical Study ID: GLP107085 Study Title: A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01406262 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Nyckelord

Versioner (1)
  1. 2018-11-19 2018-11-19 -
Rättsinnehavare

GSK group of companies

Uppladdad den

19 november 2018

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

  • Senaste
  • Äldsta
  • Önskad
  • Senaste
    • Senaste
    • Äldsta
    • Önskad

Inga kommentarer

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085

Engelsk

Pancreatitis Patient Data

1 Formulär  
Administrative data
Beskrivning

Administrative data

Study Name
Beskrivning

Study Name

Datatyp

text

Site
Beskrivning

Site

Datatyp

text

Subject
Beskrivning

Subject

Datatyp

text

Visit Name
Beskrivning

Visit Name

Datatyp

text

DCI Name/Shortname
Beskrivning

DCI Name/Shortname

Datatyp

text

Status
Beskrivning

Status

Datatyp

text

Doc#
Beskrivning

Doc#

Datatyp

integer

Visit #
Beskrivning

Visit #

Datatyp

float

Visit Date
Beskrivning

Visit Date

Datatyp

date

Visit Type
Beskrivning

Visit Type

Datatyp

text

If Repeat, please specify original day
Beskrivning

If Repeat, please specify original day

Datatyp

text

Pancreatitis
Beskrivning

Pancreatitis

AE/SAE Number
Beskrivning

Please fax/email a copy of the subject's discharge summary or medical record associated with this event to corresponding Investigator

Datatyp

text

Date of Onset
Beskrivning

Date of Onset

Datatyp

date

Alcohol
Beskrivning

Alcohol

Was alcohol consumed on a regular basis?
Beskrivning

Was alcohol consumed on a regular basis?

Datatyp

text

If Yes, record the average number of units consumed daily
Beskrivning

If Yes, record the average number of units consumed daily

Datatyp

text

Family History of Pancreatitis
Beskrivning

Family History of Pancreatitis

Is there a Family History of Pancreatitis?
Beskrivning

Is there a Family History of Pancreatitis?

Datatyp

boolean

If Yes, check below all that apply
Beskrivning

If Yes, check below all that apply

Datatyp

text

Grandmother (maternal)
Beskrivning

Grandmother (maternal)

Datatyp

text

Grandfather (maternal)
Beskrivning

Grandfather (maternal)

Datatyp

text

Grandmother(paternal)
Beskrivning

Grandmother(paternal)

Datatyp

text

Grandfather (paternal)
Beskrivning

Grandfather (paternal)

Datatyp

text

Mother
Beskrivning

Mother

Datatyp

text

Father
Beskrivning

Father

Datatyp

text

Sibling, specify
Beskrivning

Sibling, specify

Datatyp

text

Sibling
Beskrivning

Sibling

Datatyp

text

Other, specify
Beskrivning

Other, specify

Datatyp

text

Other
Beskrivning

Other

Datatyp

text

Recent Trauma/Vascular Invasive Procedures or Surgery
Beskrivning

Recent Trauma/Vascular Invasive Procedures or Surgery

Date of Recent Trauma/Invasive Procedure
Beskrivning

Date of Recent Trauma/Invasive Procedure

Datatyp

date

Record relevant details
Beskrivning

Record relevant details

Datatyp

text

Concomitant Medications
Beskrivning

Concomitant Medications

Please confirm and record all medications, inckuding over the counter and dietary supplements, and other exposures on the Concomitant Medications section of the CRF.
Beskrivning

Please confirm and record all medications, inckuding over the counter and dietary supplements, and other exposures on the Concomitant Medications section of the CRF.

Datatyp

text

Symptoms of Gatrointestinal Illness Associated with Pancreatitis
Beskrivning

Symptoms of Gatrointestinal Illness Associated with Pancreatitis

Pain in the:
Beskrivning

Check all that apply

Datatyp

integer

If Other, specify
Beskrivning

If Other, specify

Datatyp

text

Date of Onset
Beskrivning

Date of Onset

Datatyp

date

Continuing
Beskrivning

Continuing

Datatyp

boolean

Date of Resolution
Beskrivning

Date of Resolution

Datatyp

date

Other Symptoms Associated with Pancreatitis
Beskrivning

Other Symptoms Associated with Pancreatitis

Symptom:
Beskrivning

Symptom:

Datatyp

text

If Fever, record body temperature
Beskrivning

If Fever, record body temperature

Datatyp

float

Måttenheter
  • °C
°C
If Other, specify
Beskrivning

If Other, specify

Datatyp

text

Date of Onset
Beskrivning

Date of Onset

Datatyp

date

Continuing
Beskrivning

Continuing

Datatyp

boolean

Date of Resolution
Beskrivning

Date of Resolution

Datatyp

date

Tillbaka till toppen

Similar models

Pancreatitis Patient Data

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
Study Name
Item
Study Name
text
Site
Item
Site
text
Subject
Item
Subject
text
Visit Name
Item
Visit Name
text
DCI Name/Shortname
Item
DCI Name/Shortname
text
Status
Item
Status
text
Doc#
Item
Doc#
integer
Visit #
Item
Visit #
float
Visit Date
Item
Visit Date
date
Item
Visit Type
text
Visit Type
Code List
Visit Type
CL Item
Repeat (1)
CL Item
Unscheduled (2)
If Repeat, please specify original day
Item
If Repeat, please specify original day
text
Item Group
Pancreatitis
AE/SAE Number
Item
AE/SAE Number
text
Date of Onset
Item
Date of Onset
date
Item Group
Alcohol
Item
Was alcohol consumed on a regular basis?
text
Was alcohol consumed on a regular basis?
Code List
Was alcohol consumed on a regular basis?
CL Item
Unknown (1)
CL Item
Yes (2)
CL Item
No (3)
If Yes, record the average number of units consumed daily
Item
If Yes, record the average number of units consumed daily
text
Item Group
Family History of Pancreatitis
Is there a Family History of Pancreatitis?
Item
Is there a Family History of Pancreatitis?
boolean
If Yes, check below all that apply
Item
If Yes, check below all that apply
text
Item
Grandmother (maternal)
text
Grandmother (maternal)
Code List
Grandmother (maternal)
CL Item
Unknown (1)
CL Item
Yes (2)
CL Item
No (2)
Item
Grandfather (maternal)
text
undefined item
Code List
Grandfather (maternal)
CL Item
Unknown (1)
CL Item
Yes (2)
CL Item
No (3)
Item
Grandmother(paternal)
text
Grandmother(paternal)
Code List
Grandmother(paternal)
CL Item
Unknown (1)
CL Item
Yes (2)
CL Item
No (3)
Item
Grandfather (paternal)
text
Grandfather (paternal)
Code List
Grandfather (paternal)
CL Item
Unknown (1)
CL Item
Yes (2)
CL Item
No (3)
Item
Mother
text
Mother
Code List
Mother
CL Item
Unknown (1)
CL Item
Yes (2)
CL Item
No (3)
Item
Father
text
Father
Code List
Father
CL Item
Unknown (1)
CL Item
Yes (2)
CL Item
No (2)
Sibling, specify
Item
Sibling, specify
text
Item
Sibling
text
Siblings
Code List
Sibling
CL Item
Unknown (1)
CL Item
Yes (2)
CL Item
No (3)
Other, specify
Item
Other, specify
text
Item
Other
text
Other
Code List
Other
CL Item
Unknown (1)
CL Item
Yes (2)
CL Item
No (3)
Item Group
Recent Trauma/Vascular Invasive Procedures or Surgery
Date of Recent Trauma/Invasive Procedure
Item
Date of Recent Trauma/Invasive Procedure
date
Record relevant details
Item
Record relevant details
text
Item Group
Concomitant Medications
Please confirm and record all medications, inckuding over the counter and dietary supplements, and other exposures on the Concomitant Medications section of the CRF.
Item
Please confirm and record all medications, inckuding over the counter and dietary supplements, and other exposures on the Concomitant Medications section of the CRF.
text
Item Group
Symptoms of Gatrointestinal Illness Associated with Pancreatitis
Item
Pain in the:
integer
Pain in the:
Code List
Pain in the:
CL Item
Epigastrium (1)
CL Item
Periumbical region (2)
CL Item
Right upper quadrant (3)
CL Item
Left upper quadrant (4)
CL Item
Right lower quadrant (5)
CL Item
Left lower quadrant (6)
CL Item
Right flank (7)
CL Item
Left flank (8)
CL Item
Back (9)
CL Item
Other (10)
If Other, specify
Item
If Other, specify
text
Date of Onset
Item
Date of Onset
date
Continuing
Item
Continuing
boolean
Date of Resolution
Item
Date of Resolution
date
Item Group
Other Symptoms Associated with Pancreatitis
Item
Symptom:
text
Symptom:
Code List
Symptom:
CL Item
Nausea (1)
CL Item
Vomiting (2)
CL Item
Fever (3)
CL Item
Other (4)
If Fever, record body temperature
Item
If Fever, record body temperature
float
If Other, specify
Item
If Other, specify
text
Date of Onset
Item
Date of Onset
date
Continuing
Item
Continuing
boolean
Date of Resolution
Item
Date of Resolution
date
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial