ID

32903

Description

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

Keywords

Versions (1)
  1. 11/19/18 11/19/18 -
Copyright Holder

GSK group of companies

Uploaded on

November 19, 2018

DOI

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License

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

English

Pancreatitis Patient Data

1 forms  
Administrative data
Description

Administrative data

Study Name
Description

Study Name

Data type

text

Site
Description

Site

Data type

text

Subject
Description

Subject

Data type

text

Visit Name
Description

Visit Name

Data type

text

DCI Name/Shortname
Description

DCI Name/Shortname

Data type

text

Status
Description

Status

Data type

text

Doc#
Description

Doc#

Data type

integer

Visit #
Description

Visit #

Data type

float

Visit Date
Description

Visit Date

Data type

date

Visit Type
Description

Visit Type

Data type

text

If Repeat, please specify original day
Description

If Repeat, please specify original day

Data type

text

Pancreatitis
Description

Pancreatitis

AE/SAE Number
Description

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

Data type

text

Date of Onset
Description

Date of Onset

Data type

date

Alcohol
Description

Alcohol

Was alcohol consumed on a regular basis?
Description

Was alcohol consumed on a regular basis?

Data type

text

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

If Yes, record the average number of units consumed daily

Data type

text

Family History of Pancreatitis
Description

Family History of Pancreatitis

Is there a Family History of Pancreatitis?
Description

Is there a Family History of Pancreatitis?

Data type

boolean

If Yes, check below all that apply
Description

If Yes, check below all that apply

Data type

text

Grandmother (maternal)
Description

Grandmother (maternal)

Data type

text

Grandfather (maternal)
Description

Grandfather (maternal)

Data type

text

Grandmother(paternal)
Description

Grandmother(paternal)

Data type

text

Grandfather (paternal)
Description

Grandfather (paternal)

Data type

text

Mother
Description

Mother

Data type

text

Father
Description

Father

Data type

text

Sibling, specify
Description

Sibling, specify

Data type

text

Sibling
Description

Sibling

Data type

text

Other, specify
Description

Other, specify

Data type

text

Other
Description

Other

Data type

text

Recent Trauma/Vascular Invasive Procedures or Surgery
Description

Recent Trauma/Vascular Invasive Procedures or Surgery

Date of Recent Trauma/Invasive Procedure
Description

Date of Recent Trauma/Invasive Procedure

Data type

date

Record relevant details
Description

Record relevant details

Data type

text

Concomitant Medications
Description

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.
Description

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

Data type

text

Symptoms of Gatrointestinal Illness Associated with Pancreatitis
Description

Symptoms of Gatrointestinal Illness Associated with Pancreatitis

Pain in the:
Description

Check all that apply

Data type

integer

If Other, specify
Description

If Other, specify

Data type

text

Date of Onset
Description

Date of Onset

Data type

date

Continuing
Description

Continuing

Data type

boolean

Date of Resolution
Description

Date of Resolution

Data type

date

Other Symptoms Associated with Pancreatitis
Description

Other Symptoms Associated with Pancreatitis

Symptom:
Description

Symptom:

Data type

text

If Fever, record body temperature
Description

If Fever, record body temperature

Data type

float

Measurement units
  • °C
°C
If Other, specify
Description

If Other, specify

Data type

text

Date of Onset
Description

Date of Onset

Data type

date

Continuing
Description

Continuing

Data type

boolean

Date of Resolution
Description

Date of Resolution

Data type

date

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Similar models

Pancreatitis Patient Data

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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