ID

32903

Beschreibung

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

Stichworte

Versionen (1)
  1. 2018-11-19 2018-11-19 -
Rechteinhaber

GSK group of companies

Hochgeladen am

19 november 2018

DOI

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

Englisch

Pancreatitis Patient Data

1 Formulare  
Administrative data
Beschreibung

Administrative data

Study Name
Beschreibung

Study Name

Datentyp

text

Site
Beschreibung

Site

Datentyp

text

Subject
Beschreibung

Subject

Datentyp

text

Visit Name
Beschreibung

Visit Name

Datentyp

text

DCI Name/Shortname
Beschreibung

DCI Name/Shortname

Datentyp

text

Status
Beschreibung

Status

Datentyp

text

Doc#
Beschreibung

Doc#

Datentyp

integer

Visit #
Beschreibung

Visit #

Datentyp

float

Visit Date
Beschreibung

Visit Date

Datentyp

date

Visit Type
Beschreibung

Visit Type

Datentyp

text

If Repeat, please specify original day
Beschreibung

If Repeat, please specify original day

Datentyp

text

Pancreatitis
Beschreibung

Pancreatitis

AE/SAE Number
Beschreibung

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

Datentyp

text

Date of Onset
Beschreibung

Date of Onset

Datentyp

date

Alcohol
Beschreibung

Alcohol

Was alcohol consumed on a regular basis?
Beschreibung

Was alcohol consumed on a regular basis?

Datentyp

text

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

If Yes, record the average number of units consumed daily

Datentyp

text

Family History of Pancreatitis
Beschreibung

Family History of Pancreatitis

Is there a Family History of Pancreatitis?
Beschreibung

Is there a Family History of Pancreatitis?

Datentyp

boolean

If Yes, check below all that apply
Beschreibung

If Yes, check below all that apply

Datentyp

text

Grandmother (maternal)
Beschreibung

Grandmother (maternal)

Datentyp

text

Grandfather (maternal)
Beschreibung

Grandfather (maternal)

Datentyp

text

Grandmother(paternal)
Beschreibung

Grandmother(paternal)

Datentyp

text

Grandfather (paternal)
Beschreibung

Grandfather (paternal)

Datentyp

text

Mother
Beschreibung

Mother

Datentyp

text

Father
Beschreibung

Father

Datentyp

text

Sibling, specify
Beschreibung

Sibling, specify

Datentyp

text

Sibling
Beschreibung

Sibling

Datentyp

text

Other, specify
Beschreibung

Other, specify

Datentyp

text

Other
Beschreibung

Other

Datentyp

text

Recent Trauma/Vascular Invasive Procedures or Surgery
Beschreibung

Recent Trauma/Vascular Invasive Procedures or Surgery

Date of Recent Trauma/Invasive Procedure
Beschreibung

Date of Recent Trauma/Invasive Procedure

Datentyp

date

Record relevant details
Beschreibung

Record relevant details

Datentyp

text

Concomitant Medications
Beschreibung

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.
Beschreibung

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

Datentyp

text

Symptoms of Gatrointestinal Illness Associated with Pancreatitis
Beschreibung

Symptoms of Gatrointestinal Illness Associated with Pancreatitis

Pain in the:
Beschreibung

Check all that apply

Datentyp

integer

If Other, specify
Beschreibung

If Other, specify

Datentyp

text

Date of Onset
Beschreibung

Date of Onset

Datentyp

date

Continuing
Beschreibung

Continuing

Datentyp

boolean

Date of Resolution
Beschreibung

Date of Resolution

Datentyp

date

Other Symptoms Associated with Pancreatitis
Beschreibung

Other Symptoms Associated with Pancreatitis

Symptom:
Beschreibung

Symptom:

Datentyp

text

If Fever, record body temperature
Beschreibung

If Fever, record body temperature

Datentyp

float

Maßeinheiten
  • °C
°C
If Other, specify
Beschreibung

If Other, specify

Datentyp

text

Date of Onset
Beschreibung

Date of Onset

Datentyp

date

Continuing
Beschreibung

Continuing

Datentyp

boolean

Date of Resolution
Beschreibung

Date of Resolution

Datentyp

date

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Ähnliche Modelle

Pancreatitis Patient Data

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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