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ID
33832
Beschreibung
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
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- 02.01.19 02.01.19 -
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GSK group of companies
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2. Januar 2019
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Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032
Various Adverse Events: Hypoglycemia, Injection Site Reaction, Pancreatitis, Thyroid Nodes
Ähnliche Modelle
Various Adverse Events: Hypoglycemia, Injection Site Reaction, Pancreatitis, Thyroid Nodes
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Site
Item
Site
text
Subject
Item
Subject
text
CL Item
Hypoglycemia (1)
Status
Item
Status
text
Document Number
Item
Document Number
text
any protocol defined hypoglycaemic events?
Item
Has the subject experiences any protocol defined hypoglycaemic events?
boolean
If Yes, please add Hypoglycaemic Event details on the following form.
Item
If Yes, please add Hypoglycaemic Event details on the following form.
text
AE/SAE Reference Number
Item
AE/SAE Reference Number
integer
Start date of Event
Item
Start date of Event
date
Start Time of Event
Item
Start Time of Event
time
End date of Event
Item
End date of Event
date
End time of Event
Item
End time of Event
time
Blood Glucose Test Result at Time of Event
Item
Blood Glucose Test Result at Time of Event
text
CL Item
mg/dL (1)
CL Item
mmol/L (2)
CL Item
Single episode (1)
CL Item
Intermittent (2)
CL Item
Severe (1)
CL Item
Documented Symptomatic (2)
CL Item
Asymptomatic (3)
CL Item
Probable Symptomatic (4)
CL Item
Relative (5)
CL Item
Not Applicable (6)
CL Item
Assistance provided to the subject by a non-healthcare professionals (e.g., relative or non-relative) at the location of the hypoglycemic event (1)
CL Item
Assistance provided to the subject by a healthcare professional (i.re., a nurse, physician, or emergency medical service was contacted and responded) at the location of the hypoglycemic event (2)
CL Item
Event required an unscheduled visit to the investigator (but did not require hospitalization) (3)
CL Item
Event required a visit to another healthcare professional (but did not require hospitalization) (4)
CL Item
The event required a visit to the emergency room (5)
CL Item
The subject required hospitalization (record the number of hospitalization days further) (6)
number of hospitalization days
Item
Record the number of hospitalization days
integer
CL Item
None (1)
CL Item
Minor; Administered sugary drinks or sweets (2)
CL Item
Immediate; glucose drinks or supplements (3)
CL Item
Extensive; glucose injection/infusion/glucagon (4)
Item
Action Taken with Background or Anti-Hyperglycaemic Medications section
text
Code List
Action Taken with Background or Anti-Hyperglycaemic Medications section
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Applicable (3)
AE/SAE Number
Item
AE/SAE Number
integer
Date of Injection
Item
Date of Injection
date
Date of Reaction
Item
Date of Reaction
date
Size of skin reaction - length
Item
Size of skin reaction - length
integer
Size of skin reaction - width
Item
Size of skin reaction - width
integer
CL Item
Left abdomen (1)
CL Item
Right abdomen (2)
CL Item
Other (3)
If Other, specify
Item
If Other, specify
text
timeframe of local reaction
Item
Was the local reaction within 24 hrs of dose?
boolean
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Specify Other symptoms
Item
Specify Other symptoms
text
Was treatment given for this local reaction?
Item
Was treatment given for this local reaction?
boolean
serum sample obtained?
Item
Was the serum sample obtained?
boolean
If Yes, please provide date
Item
If Yes, please provide date
date
AE/SAE Number
Item
AE/SAE Number
integer
Date of Onset
Item
Date of Onset
date
CL Item
Unknown (1)
CL Item
Yes (record the average number of units) (2)
CL Item
No (3)
Average number of units consumed daily
Item
Average number of units consumed daily
integer
Family History of Pancreatitis
Item
Is there a family history of Pancreatitis?
boolean
CL Item
Unknown (1)
CL Item
Yes (2)
CL Item
No (3)
CL Item
Unknown (1)
CL Item
Yes (2)
CL Item
No (3)
CL Item
Unknown (1)
CL Item
Yes (2)
CL Item
No (3)
CL Item
Unknown (1)
CL Item
Yes (2)
CL Item
No (3)
CL Item
Unknown (1)
CL Item
Yes (2)
CL Item
No (3)
CL Item
Unknown (1)
CL Item
Yes (2)
CL Item
No (3)
CL Item
Unknown (1)
CL Item
Yes (2)
CL Item
No (3)
specify
Item
specify
text
CL Item
Unknown (1)
CL Item
Yes (2)
CL Item
No (3)
specify
Item
specify
text
CL Item
Unknown (1)
CL Item
Yes (2)
CL Item
No (3)
specify
Item
specify
text
Recent Trauma / Vascular Invasive Procedures or Surgery
Item
Recent Trauma / Vascular Invasive Procedures or Surgery
text
Date of Procedure
Item
Date of Procedure
date
Recent Trauma / Vascular Invasive Procedures or Surgery
Item
Recent Trauma / Vascular Invasive Procedures or Surgery
text
Date of Procedure
Item
Date of Procedure
date
Recent Trauma / Vascular Invasive Procedures or Surgery
Item
Recent Trauma / Vascular Invasive Procedures or Surgery
text
Date of Procedure
Item
Date of Procedure
date
Item Group
Symptoms of Gastrointestinal Illness Associated with Pancreatitis
Check below all that apply
Item
text
Date of Onset
Item
Date of Onset
date
Ongoing?
Item
Ongoing?
boolean
Date of Resolution
Item
Date of Resolution
date
Date of Onset
Item
Date of Onset
date
Ongoing?
Item
Ongoing?
boolean
Date of Resolution
Item
Date of Resolution
date
Date of Onset
Item
Date of Onset
date
Ongoing?
Item
Ongoing?
boolean
Date of Resolution
Item
Date of Resolution
date
Date of Onset
Item
Date of Onset
date
Ongoing?
Item
Ongoing?
boolean
Date of Resolution
Item
Date of Resolution
date
Date of Onset
Item
Date of Onset
date
Ongoing?
Item
Ongoing?
boolean
Date of Resolution
Item
Date of Resolution
date
Date of Onset
Item
Date of Onset
date
Ongoing?
Item
Ongoing?
boolean
Date of Resolution
Item
Date of Resolution
date
Date of Onset
Item
Date of Onset
date
Ongoing?
Item
Ongoing?
boolean
Date of Resolution
Item
Date of Resolution
date
Date of Onset
Item
Date of Onset
date
Ongoing?
Item
Ongoing?
boolean
Date of Resolution
Item
Date of Resolution
date
Date of Onset
Item
Date of Onset
date
Ongoing?
Item
Ongoing?
boolean
Date of Resolution
Item
Date of Resolution
date
Date of Onset
Item
Date of Onset
date
Ongoing?
Item
Ongoing?
boolean
Date of Resolution
Item
Date of Resolution
date
Date of Onset
Item
Date of Onset
date
Ongoing?
Item
Ongoing?
boolean
Date of Resolution
Item
Date of Resolution
date
Date of Onset
Item
Date of Onset
date
Ongoing?
Item
Ongoing?
boolean
Date of Resolution
Item
Date of Resolution
date
Temperature
Item
Temperature
float
Date of Onset
Item
Date of Onset
date
Ongoing?
Item
Ongoing?
boolean
Date of Resolution
Item
Date of Resolution
date
Record lab results in corresponding categories below
Item
Record lab results in corresponding categories below
text
Was lab test performed?
Item
Was lab test performed?
boolean
Lab Test Result
Item
Lab Test Result
text
Lab Unit
Item
Lab Unit
text
Other lab unit, specify
Item
Other lab unit, specify
text
Lab LLN
Item
Lab LLN
text
Lab ULN
Item
Lab ULN
text
Was lab test performed?
Item
Was lab test performed?
boolean
Lab Test Result
Item
Lab Test Result
text
Lab Unit
Item
Lab Unit
text
Other lab unit, specify
Item
Other lab unit, specify
text
Lab LLN
Item
Lab LLN
text
Lab ULN
Item
Lab ULN
text
Was lab test performed?
Item
Was lab test performed?
boolean
Lab Test Result
Item
Lab Test Result
text
Lab Unit
Item
Lab Unit
text
Other lab unit, specify
Item
Other lab unit, specify
text
Lab LLN
Item
Lab LLN
text
Lab ULN
Item
Lab ULN
text
Was lab test performed?
Item
Was lab test performed?
boolean
Lab Test Result
Item
Lab Test Result
text
Lab Unit
Item
Lab Unit
text
Other lab unit, specify
Item
Other lab unit, specify
text
Lab LLN
Item
Lab LLN
text
Lab ULN
Item
Lab ULN
text
Specify test
Item
Specify test
text
Lab Test Result
Item
Lab Test Result
text
Lab Unit
Item
Lab Unit
text
Other lab unit, specify
Item
Other lab unit, specify
text
Lab LLN
Item
Lab LLN
text
Lab ULN
Item
Lab ULN
text
Were additional Lab-Results Biochemistry evaluations performed?
Item
Were additional Lab-Results Biochemistry evaluations performed?
boolean
Was Abdominal Ultrasound performed?
Item
Was Abdominal Ultrasound performed?
boolean
Date of abdominal ultrasound
Item
Date of abdominal ultrasound
date
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Unknown (1)
CL Item
Yes (2)
CL Item
No (3)
Was an additional Abdominal Ultrasound performed?
Item
Was an additional Abdominal Ultrasound performed?
boolean
Was an abdominal CT Scan performed?
Item
Was an abdominal CT Scan performed?
boolean
If Yes, Date of Abdominal CT
Item
If Yes, Date of Abdominal CT
date
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
If Abnormal, what are the diagnostic findings?
text
Code List
If Abnormal, what are the diagnostic findings?
CL Item
Unknown (1)
CL Item
Cholelithiasis (2)
CL Item
Pancreatic fluid collection (3)
CL Item
Pseudocysts (4)
CL Item
Edema of the small bowel mesentery (5)
CL Item
Pancreatic necrosis (6)
CL Item
Focal edema of the pancreas (7)
CL Item
Other (8)
Specify other
Item
Specify other
text
Was an additional Abdominal CT Scan performed?
Item
Was an additional Abdominal CT Scan performed?
boolean
Was MRI performed?
Item
Was MRI performed?
boolean
Date of MRI
Item
Date of MRI
date
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
If Abnormal, what was the diagnostic finding?
integer
Code List
If Abnormal, what was the diagnostic finding?
CL Item
Unknown (1)
CL Item
Cholelithiasis (2)
CL Item
Pancreatic fluid collection (3)
CL Item
Pseudocysts (4)
CL Item
Edema of the small bowel mesentery (5)
CL Item
Pancreatic necrosis (6)
CL Item
Focal edema of the pancreas (7)
CL Item
Diffuse edema of the pancreas (8)
CL Item
Other (9)
Was additional MRI performed?
Item
Was additional MRI performed?
boolean
Date of evaluation at which new nodule appeared
Item
Date of evaluation at which new nodule appeared
date
AE/SAE Reference Number
Item
AE/SAE Reference Number
integer
CL Item
Solitary nodule (1)
CL Item
Multinodular (2)
CL Item
Right upper lobe (1)
CL Item
Left upper lobe (2)
CL Item
Right lower lobe (3)
CL Item
Left lower lobe (4)
CL Item
Isthmus (5)
length
Item
length
float
width
Item
width
float
Was an action taken?
Item
Was an action taken?
boolean
CL Item
Ultrasound (1)
CL Item
RIU (2)
CL Item
Technetium scan (3)
CL Item
Physical exam (4)
CL Item
Fine needle aspirate (5)
CL Item
Surgery (6)
CL Item
Thyroid function tests (7)
Item
If Diagnostic Method was Fine Needle aspirate, please provide pathology results
text
Code List
If Diagnostic Method was Fine Needle aspirate, please provide pathology results
CL Item
Non-diagnostic (1)
CL Item
Benign (2)
CL Item
Malignant, thyroid cancer (3)
Item
If Malignant, thyroid cancer, check all that apply
text
Code List
If Malignant, thyroid cancer, check all that apply
CL Item
Papillary (1)
CL Item
Follicular (2)
CL Item
Metastatic (3)
CL Item
Medullary (4)
CL Item
Aplastic (5)
Was an action taken due to fine needle aspirate pathology result?
Item
Was an action taken due to fine needle aspirate pathology result?
boolean
If Yes, please provide details:
Item
If Yes, please provide details:
text
Record the details below
Item
Record the details below
boolean
Result
Item
Result
text
Unit
Item
Unit
text
LLN
Item
LLN
text
ULN
Item
ULN
text
Result
Item
Result
text
Unit
Item
Unit
text
LLN
Item
LLN
text
ULN
Item
ULN
text
Result
Item
Result
text
Unit
Item
Unit
text
LLN
Item
LLN
text
ULN
Item
ULN
text
Result
Item
Result
text
Unit
Item
Unit
text
LLN
Item
LLN
text
ULN
Item
ULN
text
Result
Item
Result
text
Unit
Item
Unit
text
LLN
Item
LLN
text
ULN
Item
ULN
text