Information:
Fel:
ID
33556
Beskrivning
Study ID: 107032 Clinical Study ID: GLP107032 Study Title: An open-label study to evaluate the pharmacokinetics of an oral contraceptive containing Norethindrone and Ethinyl Estradiol when co-administered with GSK716155 in healthy adult female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01077505 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)
- 2018-12-12 2018-12-12 -
Rättsinnehavare
GSK group of companies
Uppladdad den
12 december 2018
DOI
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Licens
Creative Commons BY-NC 3.0
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Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032
Visit 10: Adverse Events/Severe Adverse Event Form
- StudyEvent: ODM
Similar models
Visit 10: Adverse Events/Severe Adverse Event Form
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Site
Item
Site
text
Subject
Item
Subject
text
CL Item
Adverse Events (1)
Status
Item
Status
text
Doc №
Item
Doc №
integer
blank page?
Item
Is Page Blank?
boolean
Adverse Event Number
Item
Adverse Event Number
integer
Diagnosis or Sign/Symptom
Item
Diagnosis or Sign/Symptom
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)
Start date
Item
Start date
date
End date
Item
End 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)
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Investigational product(s) withdrawn (1)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)
Withdrawal
Item
Did the subject withdraw from study as a result of this AE?
boolean
Relationship to Investigational Prosuct(s)
Item
Is there a reasonable possibility the AE may ave been caused by the investigational product?
boolean
Concomitant medication
Item
Was a concomitant medication/non-drug therapy taken for this AE?
boolean
seriousness
Item
Was event serious?
boolean
Adverse Event Number
Item
Adverse Event Number
integer
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
Adverse Event Number
Item
Adverse Event Number
integer
Date of birth
Item
Date of birth
date
CL Item
Male (M)
CL Item
Female (F)
Weight
Item
Weight
float
Item Group
Section 4 - Adverse event after Investigational product withdrawal
Adverse Event Number
Item
Adverse Event Number
integer
If investigational Product(s) was stopped, did the reported event(s) recur after further investigational product(s) were administered?
Item
If investigational Product(s) was stopped, did the reported event(s) recur after further investigational product(s) were administered?
boolean
Adverse Event Number
Item
Adverse Event Number
integer
CL Item
Disease under study (1)
CL Item
Medical condition (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
Relevant Medical Condition
Item
Relevant Medical Condition
text
Diagnosis
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 occurrence
Item
If No, record date of last occurrence
date
Adverse Event Number
Item
Adverse Event Number
integer
Provide any family or social history relevant to the SAE
Item
Provide any family or social history relevant to the SAE
text
Other relevant risk factors
Item
Other relevant risk factors
text
Item Group
Section 8 - Relevant Concomitant Medications
Adverse Event Number
Item
Adverse Event Number
integer
Drug Name (Trade name preferred)
Item
Drug Name (Trade name preferred)
text
Dose
Item
Dose
text
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
Item Group
Section 9 - Details of Investigational Product
Adverse Event Number
Item
Adverse Event Number
integer
Record any necessary details of investigatonal product
Item
Record any necessary details of investigatonal product
text
Adverse Event Number
Item
Adverse Event Number
integer
details of relevant assessment
Item
Provide details of any other test/procedures which were carried out to diagnose or confirm the SAE
text
details of relevant assessment
Item
Further details of relevant assessment
text
details of relevant assessment
Item
Further details of relevant assessment
text
brief narrative description
Item
Provide a brief narrative description of the SAE and details of treating given
text
brief narrative description
Item
Further narrative remarks
text
brief narrative description
Item
Further narrative remarks
text