Informações:
Falhas:
ID
32739
Descrição
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
Palavras-chave
Versões (1)
- 14/11/2018 14/11/2018 -
Titular dos direitos
GSK group of companies
Transferido a
14 de novembro de 2018
DOI
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Licença
Creative Commons BY-NC 3.0
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The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085
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Adverse Events Form
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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
Has the Subject experienced any adverse events?
Item
Has the Subject experienced any adverse events?
boolean
If YES, please add Adverse Event details below
Item
If YES, please add Adverse Event details below
text
Adverse Event Number
Item
Adverse Event Number
text
Event
Item
Event
text
CL Item
Hypoglycemic (1)
CL Item
Thyroid (2)
CL Item
GI (3)
CL Item
Cardiovascular (4)
CL Item
Liver (5)
CL Item
Injection site reaction (6)
CL Item
Diabetic retinopathy (7)
CL Item
Other (8)
If Other, specify
Item
If Other, specify
text
Start Date
Item
Start Date
date
CL Item
Recovered/resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/not resolved (3)
CL Item
Recovered/resolved with sequelae (4)
CL Item
Fatal (5)
End Date
Item
End Date
date
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Item
Action Taken with Investigational Product(s) as a Result of the AE
text
Code List
Action Taken with Investigational Product(s) as a Result of the AE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose not changed (2)
CL Item
Not applicable (3)
Did the subject withdraw from study as a result of this AE?
Item
Did the subject withdraw from study as a result of this AE?
boolean
Is there a reasonable possibility the AE may have been caused by the investigational product?
Item
Is there a reasonable possibility the AE may have been caused by the investigational product?
boolean
Item
Was a concomitant medication/non-drug therapy taken for this AE?
text
Code List
Was a concomitant medication/non-drug therapy taken for this AE?
CL Item
Yes (please record on Concomitant Medications page) (1)
CL Item
No (2)
Was event serious?
Item
Was event serious?
boolean
Item
Specify reason(s) for considering this a SAE, check all that apply
text
Code List
Specify reason(s) for considering this a SAE, check all that apply
CL Item
Results in death (1)
CL Item
Is life-threatening (2)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (3)
CL Item
Results in disability/incapacity (4)
CL Item
Congenital anomaly/birth defect (5)
CL Item
Other (6)
If Other, specify
Item
If Other, specify
text
Date of Birth
Item
Date of Birth
date
CL Item
Male (1)
CL Item
Female (2)
Weight
Item
Weight
float
Item
If Investigational Product(s) was stopped, did the reported event(s) recur after further Investigational Product(s) were administered?
text
Code List
If Investigational Product(s) was stopped, did the reported event(s) recur after further Investigational Product(s) were administered?
CL Item
Not Applicable (1)
Item
Possible causes of SAE other than Investigational Product(s)
text
Code List
Possible causes of SAE other than Investigational Product(s)
CL Item
Disease under study (1)
CL Item
Medical condition(s) (2)
CL Item
Lack of efficacy (3)
CL Item
Withdrawal of investigational product(s) (4)
CL Item
Concomitant medication(s) (5)
CL Item
Activity related to study participation (e.g. procedures) (6)
CL Item
Other (7)
If Other, specify
Item
If Other, specify
text
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
Item
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
text
Date of Onset
Item
Date of Onset
date
Condition present at time of the SAE?
Item
Condition present at time of the SAE?
boolean
If No, record date of last occurence
Item
If No, record date of last occurence
date
Provide any family or social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE
Item
Provide any family or social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE
text
Item Group
Section 8 - Relevant Concomitant Medications
Drug Name
Item
Drug Name
text
Dose
Item
Dose
integer
Unit
Item
Unit
text
Frequency
Item
Frequency
text
Route
Item
Route
text
Taken prior to study
Item
Taken prior to study
boolean
Start Date
Item
Start Date
date
Stop Date
Item
Stop Date
date
Ongoing medication?
Item
Ongoing medication?
boolean
Reason for medication
Item
Reason for medication
text
Details of Investigational Product
Item
Details of Investigational Product
text
Provide details of any other tests/procedures which were carried out to diagnose of confirm the SAE
Item
Provide details of any other tests/procedures which were carried out to diagnose of confirm the SAE
text
Provide a brief narrative description of the SAE and details of treatment given
Item
Provide a brief narrative description of the SAE and details of treatment given
text