ID

32903

Descripción

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

Palabras clave

Versiones (1)
  1. 19/11/18 19/11/18 -
Titular de derechos de autor

GSK group of companies

Subido en

19 de noviembre de 2018

DOI

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Licencia

Creative Commons BY-NC 3.0
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The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085

Inglés

Pancreatitis Patient Data

1 formularios  
Administrative data
Descripción

Administrative data

Study Name
Descripción

Study Name

Tipo de datos

text

Site
Descripción

Site

Tipo de datos

text

Subject
Descripción

Subject

Tipo de datos

text

Visit Name
Descripción

Visit Name

Tipo de datos

text

DCI Name/Shortname
Descripción

DCI Name/Shortname

Tipo de datos

text

Status
Descripción

Status

Tipo de datos

text

Doc#
Descripción

Doc#

Tipo de datos

integer

Visit #
Descripción

Visit #

Tipo de datos

float

Visit Date
Descripción

Visit Date

Tipo de datos

date

Visit Type
Descripción

Visit Type

Tipo de datos

text

If Repeat, please specify original day
Descripción

If Repeat, please specify original day

Tipo de datos

text

Pancreatitis
Descripción

Pancreatitis

AE/SAE Number
Descripción

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

Tipo de datos

text

Date of Onset
Descripción

Date of Onset

Tipo de datos

date

Alcohol
Descripción

Alcohol

Was alcohol consumed on a regular basis?
Descripción

Was alcohol consumed on a regular basis?

Tipo de datos

text

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

If Yes, record the average number of units consumed daily

Tipo de datos

text

Family History of Pancreatitis
Descripción

Family History of Pancreatitis

Is there a Family History of Pancreatitis?
Descripción

Is there a Family History of Pancreatitis?

Tipo de datos

boolean

If Yes, check below all that apply
Descripción

If Yes, check below all that apply

Tipo de datos

text

Grandmother (maternal)
Descripción

Grandmother (maternal)

Tipo de datos

text

Grandfather (maternal)
Descripción

Grandfather (maternal)

Tipo de datos

text

Grandmother(paternal)
Descripción

Grandmother(paternal)

Tipo de datos

text

Grandfather (paternal)
Descripción

Grandfather (paternal)

Tipo de datos

text

Mother
Descripción

Mother

Tipo de datos

text

Father
Descripción

Father

Tipo de datos

text

Sibling, specify
Descripción

Sibling, specify

Tipo de datos

text

Sibling
Descripción

Sibling

Tipo de datos

text

Other, specify
Descripción

Other, specify

Tipo de datos

text

Other
Descripción

Other

Tipo de datos

text

Recent Trauma/Vascular Invasive Procedures or Surgery
Descripción

Recent Trauma/Vascular Invasive Procedures or Surgery

Date of Recent Trauma/Invasive Procedure
Descripción

Date of Recent Trauma/Invasive Procedure

Tipo de datos

date

Record relevant details
Descripción

Record relevant details

Tipo de datos

text

Concomitant Medications
Descripción

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.
Descripción

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

Tipo de datos

text

Symptoms of Gatrointestinal Illness Associated with Pancreatitis
Descripción

Symptoms of Gatrointestinal Illness Associated with Pancreatitis

Pain in the:
Descripción

Check all that apply

Tipo de datos

integer

If Other, specify
Descripción

If Other, specify

Tipo de datos

text

Date of Onset
Descripción

Date of Onset

Tipo de datos

date

Continuing
Descripción

Continuing

Tipo de datos

boolean

Date of Resolution
Descripción

Date of Resolution

Tipo de datos

date

Other Symptoms Associated with Pancreatitis
Descripción

Other Symptoms Associated with Pancreatitis

Symptom:
Descripción

Symptom:

Tipo de datos

text

If Fever, record body temperature
Descripción

If Fever, record body temperature

Tipo de datos

float

Unidades de medida
  • °C
°C
If Other, specify
Descripción

If Other, specify

Tipo de datos

text

Date of Onset
Descripción

Date of Onset

Tipo de datos

date

Continuing
Descripción

Continuing

Tipo de datos

boolean

Date of Resolution
Descripción

Date of Resolution

Tipo de datos

date

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Similar models

Pancreatitis Patient Data

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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
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