Information:
Fel:
ID
41629
Beskrivning
Study ID: 108366 Clinical Study ID: 108366 Study Title: An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Albiglutide in Healthy Adult Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01147692 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: simvastatin plus albiglutide Trade Name: simvastatin plus albiglutide Study Indication: Diabetes Mellitus, Type 2
Nyckelord
Versioner (2)
- 2020-11-16 2020-11-16 -
- 2020-11-29 2020-11-29 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
29 november 2020
DOI
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Licens
Creative Commons BY 4.0
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Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692
Study Completion; Unscheduled Visit; Hypoglycaemia; Injection Site Reaction
Similar models
Study Completion; Unscheduled Visit; Hypoglycaemia; Injection Site Reaction
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Site
Item
Site
text
C2825164 (UMLS CUI [1])
Subject
Item
Subject
text
C2348585 (UMLS CUI [1])
Status
Item
Status
text
C0449438 (UMLS CUI [1])
Doc#
Item
Doc#
integer
C1301746 (UMLS CUI [1])
Is Page Blank?
Item
Is Page Blank?
boolean
C1704732 (UMLS CUI [1,1])
C0750479 (UMLS CUI [1,2])
C0750479 (UMLS CUI [1,2])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Date of final contact
Item
Date of final contact
date
C0805839 (UMLS CUI [1])
Date of last dose
Item
Date of last dose
date
C1762893 (UMLS CUI [1])
Did subject complete the study?
Item
Did subject complete the study?
boolean
C2348577 (UMLS CUI [1])
Date of discontinuation
Item
Date of discontinuation
date
C0457454 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item
If subject did not complete the study, mark ONE reason
integer
C3827242 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
Code List
If subject did not complete the study, mark ONE reason
CL Item
Liver chemistry stopping criteria (specify AE No) (1)
CL Item
Adverse event (specify AE No) (2)
CL Item
Severe or repeated occurences of hypoglycaemia (specify AE No) (3)
CL Item
Occurence of Pancreatitits (AE No) (4)
CL Item
Consent withdrawn (5)
CL Item
Lost to Follow-Up (6)
CL Item
Protocol violation (7)
CL Item
Noncompliance with study visit schedule (8)
CL Item
Termination of study by sponsor (9)
CL Item
Pregnancy (10)
CL Item
Other (specify in comments) (11)
Specify AE No (Liver chemistry stopping criteria)
Item
Specify AE No (Liver chemistry stopping criteria)
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0023884 (UMLS CUI [2,1])
C0008000 (UMLS CUI [2,2])
C2746065 (UMLS CUI [3,1])
C0243161 (UMLS CUI [3,2])
C0237753 (UMLS CUI [1,2])
C0023884 (UMLS CUI [2,1])
C0008000 (UMLS CUI [2,2])
C2746065 (UMLS CUI [3,1])
C0243161 (UMLS CUI [3,2])
Specify AE No (Adverse event)
Item
Specify AE No (Adverse event)
integer
C0877248 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
Specify AE No (Severe or repeated occurences of hypoglycaemia)
Item
Specify AE No (Severe or repeated occurences of hypoglycaemia)
integer
C0877248 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0342316 (UMLS CUI [2])
C0237753 (UMLS CUI [1,2])
C0342316 (UMLS CUI [2])
Specify AE No (Occurence of Pancreatitis)
Item
Specify AE No (Occurence of Pancreatitis)
integer
C0877248 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0030305 (UMLS CUI [2])
C0237753 (UMLS CUI [1,2])
C0030305 (UMLS CUI [2])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
Vital Signs (Unscheduled)
C0518766 (UMLS CUI-1)
C3854240 (UMLS CUI-2)
C3854240 (UMLS CUI-2)
Item
Vital Signs - Repeat or Unscheduled?
integer
C0518766 (UMLS CUI [1])
C0205341 (UMLS CUI [2])
C3854240 (UMLS CUI [3])
C0205341 (UMLS CUI [2])
C3854240 (UMLS CUI [3])
CL Item
Repeat (1)
CL Item
Unscheduled (2)
Vital Signs - If Repeat, please specify original period/day
Item
Vital Signs - If Repeat, please specify original period/day
text
C0518766 (UMLS CUI [1])
C0205341 (UMLS CUI [2])
C2347804 (UMLS CUI [3])
C0439228 (UMLS CUI [4])
C0205341 (UMLS CUI [2])
C2347804 (UMLS CUI [3])
C0439228 (UMLS CUI [4])
Vital Signs - Date
Item
Vital Signs - Date
date
C2826644 (UMLS CUI [1])
Vital Signs - Time
Item
Vital Signs - Time
time
C2826762 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
Respirations
Item
Respirations
integer
C0035203 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item
Vital Signs - Body Position
integer
C0518766 (UMLS CUI [1,1])
C1262869 (UMLS CUI [1,2])
C1262869 (UMLS CUI [1,2])
CL Item
Sitting (1)
CL Item
Standing (2)
CL Item
Supine (3)
Vital Signs - Comment
Item
Vital Signs - Comment
text
C0518766 (UMLS CUI [1])
C0947611 (UMLS CUI [2])
C0947611 (UMLS CUI [2])
Item Group
Physical Examination (Unscheduled Visit)
C0031809 (UMLS CUI-1)
C3854240 (UMLS CUI-2)
C3854240 (UMLS CUI-2)
Date of Physical Exam
Item
Date of Physical Exam
date
C2826643 (UMLS CUI [1])
CL Item
Skin including Injection Site (1)
CL Item
Head, Eyes, Ears, Nose, Throat (2)
CL Item
Thyroid (3)
CL Item
Central Nervous System (4)
CL Item
Respiratory System (5)
CL Item
Cardiovascular System (6)
CL Item
Abdomen (Liver and Spleen) (7)
CL Item
Lymph Nodes (8)
CL Item
Extremities (9)
CL Item
Other (10)
Item Group
Electrocardiogram (Unscheduled)
C0013798 (UMLS CUI-1)
C3854240 (UMLS CUI-2)
C3854240 (UMLS CUI-2)
Item
Electrocardiogram - Repeat or Unscheduled?
integer
C0013798 (UMLS CUI [1])
C0205341 (UMLS CUI [2])
C3854240 (UMLS CUI [3])
C0205341 (UMLS CUI [2])
C3854240 (UMLS CUI [3])
CL Item
Repeat (1)
CL Item
Unscheduled (2)
Electrocardiogram - If Repeat, please specify original Period/Day
Item
Electrocardiogram - If Repeat, please specify original Period/Day
text
C0013798 (UMLS CUI [1])
C0205341 (UMLS CUI [2])
C2347804 (UMLS CUI [3])
C0439228 (UMLS CUI [4])
C0205341 (UMLS CUI [2])
C2347804 (UMLS CUI [3])
C0439228 (UMLS CUI [4])
Electrocardiogram - Date
Item
Electrocardiogram - Date
date
C2826640 (UMLS CUI [1])
Electrocardiogram - Time
Item
Electrocardiogram - Time
time
C0013798 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
Electrocardiogram - Heart Rate
Item
Electrocardiogram - Heart Rate
integer
C0013798 (UMLS CUI [1])
C0018810 (UMLS CUI [2])
C0018810 (UMLS CUI [2])
Electrocardiogram - PR Interval
Item
Electrocardiogram - PR Interval
integer
C0429087 (UMLS CUI [1])
Electrocardiogram - QRS Duration
Item
Electrocardiogram - QRS Duration
integer
C0013798 (UMLS CUI [1])
C0429025 (UMLS CUI [2])
C0429025 (UMLS CUI [2])
Electrocardiogram - QT Interval
Item
Electrocardiogram - QT Interval
integer
C0013798 (UMLS CUI [1,1])
C1287082 (UMLS CUI [1,2])
C1287082 (UMLS CUI [1,2])
Electrocardiogram - Q-TcB Interval
Item
Electrocardiogram - Q-TcB Interval
integer
C0429087 (UMLS CUI [1,1])
C1882512 (UMLS CUI [1,2])
C1882512 (UMLS CUI [1,2])
Electrocardiogram - Q-TcF Interval
Item
Electrocardiogram - Q-TcF Interval
integer
C0429087 (UMLS CUI [1,1])
C1882513 (UMLS CUI [1,2])
C1882513 (UMLS CUI [1,2])
Electrocardiogram - RR Interval
Item
Electrocardiogram - RR Interval
integer
C0013798 (UMLS CUI [1,1])
C0489636 (UMLS CUI [1,2])
C0489636 (UMLS CUI [1,2])
Electrocardiogram - Normal Sinus Rhythm?
Item
Electrocardiogram - Normal Sinus Rhythm?
boolean
C1960147 (UMLS CUI [1])
Item
Overall Interpretation of ECG
integer
C1623258 (UMLS CUI [1,1])
C0459471 (UMLS CUI [1,2])
C0459471 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal; Not Clinically Significant (2)
CL Item
Abnormal; Clinically Significant (3)
Electrocardiogram - If abnormal, please specify
Item
Electrocardiogram - If abnormal, please specify
text
C0522055 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
Item Group
Central Laboratory Blood (Unscheduled)
C1880016 (UMLS CUI-1)
C3854240 (UMLS CUI-2)
C0005767 (UMLS CUI-3)
C3854240 (UMLS CUI-2)
C0005767 (UMLS CUI-3)
Item
Central Laboratory Blood
integer
C1880016 (UMLS CUI [1])
C0005767 (UMLS CUI [2])
C0005767 (UMLS CUI [2])
CL Item
Haematology (1)
CL Item
Chemistry (2)
CL Item
Serology (3)
CL Item
Serum HCG (4)
CL Item
SP Chem (5)
Item
Central Laboratory Blood - Repeat or Unscheduled?
integer
C0205341 (UMLS CUI [1])
C0005767 (UMLS CUI [2])
C3854240 (UMLS CUI [3])
C0005767 (UMLS CUI [2])
C3854240 (UMLS CUI [3])
CL Item
Repeat (1)
CL Item
Unscheduled (2)
Central Laboratory Blood - If Repeat, please specify original period/day:
Item
Central Laboratory Blood - If Repeat, please specify original period/day:
text
C1880016 (UMLS CUI [1])
C0005767 (UMLS CUI [2])
C0205341 (UMLS CUI [3])
C2347804 (UMLS CUI [4])
C0439228 (UMLS CUI [5])
C2348235 (UMLS CUI [6])
C0005767 (UMLS CUI [2])
C0205341 (UMLS CUI [3])
C2347804 (UMLS CUI [4])
C0439228 (UMLS CUI [5])
C2348235 (UMLS CUI [6])
Central Laboratory Blood - Sample Date
Item
Central Laboratory Blood - Sample Date
date
C1880016 (UMLS CUI [1])
C0005767 (UMLS CUI [2])
C1302413 (UMLS CUI [3])
C0005767 (UMLS CUI [2])
C1302413 (UMLS CUI [3])
Central Laboratory Blood - Sample Time
Item
Central Laboratory Blood - Sample Time
time
C1880016 (UMLS CUI [1])
C0005767 (UMLS CUI [2])
C0040223 (UMLS CUI [3,1])
C0200345 (UMLS CUI [3,2])
C0005767 (UMLS CUI [2])
C0040223 (UMLS CUI [3,1])
C0200345 (UMLS CUI [3,2])
Central Laboratory Blood - Comment
Item
Central Laboratory Blood - Comment
text
C1880016 (UMLS CUI [1])
C0005767 (UMLS CUI [2])
C0947611 (UMLS CUI [3])
C0005767 (UMLS CUI [2])
C0947611 (UMLS CUI [3])
Item Group
Central Laboratory Urine (Unscheduled)
C1880016 (UMLS CUI-1)
C3854240 (UMLS CUI-2)
C0042036 (UMLS CUI-3)
C3854240 (UMLS CUI-2)
C0042036 (UMLS CUI-3)
Item
Central Laboratory Urine
integer
C1880016 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C0042036 (UMLS CUI [1,2])
CL Item
UA (1)
CL Item
UDS (2)
CL Item
Urine HCG (3)
CL Item
Urine Chem (4)
Central Laboratory Urine - Repeat or Unscheduled?
Item
Central Laboratory Urine - Repeat or Unscheduled?
text
C0205341 (UMLS CUI [1])
C0042036 (UMLS CUI [2])
C3854240 (UMLS CUI [3])
C0042036 (UMLS CUI [2])
C3854240 (UMLS CUI [3])
Central Laboratory Urine - If Repeat, please specify original period/day:
Item
Central Laboratory Urine - If Repeat, please specify original period/day:
text
C1880016 (UMLS CUI [1])
C0042036 (UMLS CUI [2])
C0205341 (UMLS CUI [3])
C2347804 (UMLS CUI [4])
C0439228 (UMLS CUI [5])
C2348235 (UMLS CUI [6])
C0042036 (UMLS CUI [2])
C0205341 (UMLS CUI [3])
C2347804 (UMLS CUI [4])
C0439228 (UMLS CUI [5])
C2348235 (UMLS CUI [6])
Central Laboratory Urine - Sample Date
Item
Central Laboratory Urine - Sample Date
date
C1880016 (UMLS CUI [1])
C0042036 (UMLS CUI [2])
C1302413 (UMLS CUI [3])
C0042036 (UMLS CUI [2])
C1302413 (UMLS CUI [3])
Central Laboratory Urine - Sample Time
Item
Central Laboratory Urine - Sample Time
time
C1880016 (UMLS CUI [1])
C0042036 (UMLS CUI [2])
C0040223 (UMLS CUI [3,1])
C0200345 (UMLS CUI [3,2])
C0042036 (UMLS CUI [2])
C0040223 (UMLS CUI [3,1])
C0200345 (UMLS CUI [3,2])
Central Laboratory Urine - Comment
Item
Central Laboratory Urine - Comment
text
C1880016 (UMLS CUI [1])
C0042036 (UMLS CUI [2])
C0947611 (UMLS CUI [3])
C0042036 (UMLS CUI [2])
C0947611 (UMLS CUI [3])
Has the subject experienced any protocol defined hypoglycaemic events?
Item
Has the subject experienced any protocol defined hypoglycaemic events?
boolean
C0745153 (UMLS CUI [1])
C2348563 (UMLS CUI [2])
C2348563 (UMLS CUI [2])
AE/SAE Reference Event Number
Item
AE/SAE Reference Event Number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C0237753 (UMLS CUI [2,2])
C0237753 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C0237753 (UMLS CUI [2,2])
Start date of Event
Item
Start date of Event
date
C2697888 (UMLS CUI [1])
Start time of Event
Item
Start time of Event
time
C2697889 (UMLS CUI [1])
End date of Event
Item
End date of Event
date
C2697886 (UMLS CUI [1])
End time of Event
Item
End time of Event
time
C2826658 (UMLS CUI [1])
Blood Glucose Test Result at Time of Event (mg/dL)
Item
Blood Glucose Test Result at Time of Event (mg/dL)
integer
C0457578 (UMLS CUI [1])
C0040223 (UMLS CUI [2])
C2697889 (UMLS CUI [3])
C0040223 (UMLS CUI [2])
C2697889 (UMLS CUI [3])
Blood Glucose Test Result at Time of Event (mmol/L)
Item
Blood Glucose Test Result at Time of Event (mmol/L)
integer
C0457578 (UMLS CUI [1])
C0040223 (UMLS CUI [2])
C2697889 (UMLS CUI [3])
C0040223 (UMLS CUI [2])
C2697889 (UMLS CUI [3])
CL Item
Single episode (1)
CL Item
Intermittent (2)
Item
Severity of hypoglycaemic event: (per ADA working group guidelines)
integer
C1710066 (UMLS CUI [1])
C0745153 (UMLS CUI [2])
C0745153 (UMLS CUI [2])
Code List
Severity of hypoglycaemic event: (per ADA working group guidelines)
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)
Item
If Severe (at least one must be checked to fit the ADA criterion of severe), check all that apply:
integer
C0205082 (UMLS CUI [1])
Code List
If Severe (at least one must be checked to fit the ADA criterion of severe), check all that apply:
CL Item
Assistance provided to the subject by a non-healthcare professional (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.e., 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 (6)
Required days of hospitalization
Item
Required days of hospitalization
integer
C0019993 (UMLS CUI [1])
C0439228 (UMLS CUI [2])
C0439228 (UMLS CUI [2])
Item
Intervention (enter the most severe, enter details on concomitant medication page if applicable)
integer
C0184661 (UMLS CUI [1])
Code List
Intervention (enter the most severe, enter details on concomitant medication page if applicable)
CL Item
None (1)
CL Item
Minor; Adminstered sugary drinks or sweets (2)
CL Item
Immediate; glucose drinks or suppliments (3)
CL Item
Extensive; glucose injection/ infusion/ glucagon (4)
Item
Action Taken with Background or Anti-Hyperglycemic Medication?
integer
C2826626 (UMLS CUI [1])
Code List
Action Taken with Background or Anti-Hyperglycemic Medication?
CL Item
Yes (If yes, please update Anti-Hyperglycemic Medications page) (1)
CL Item
No (2)
CL Item
Not Applicable (3)
AE/SAE Number
Item
AE/SAE Number
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0237753 (UMLS CUI [2,2])
C0237753 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0237753 (UMLS CUI [2,2])
Date of injection
Item
Date of injection
date
C0011008 (UMLS CUI [1,1])
C0021485 (UMLS CUI [1,2])
C0021485 (UMLS CUI [1,2])
Date of Reaction
Item
Date of Reaction
date
C0443286 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Size of skin reaction 1. diameter
Item
Size of skin reaction 1. diameter
integer
C0221743 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C1301886 (UMLS CUI [2])
C0456389 (UMLS CUI [1,2])
C1301886 (UMLS CUI [2])
Size of skin reaction 2. diameter
Item
Size of skin reaction 2. diameter
integer
C0221743 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C1301886 (UMLS CUI [2])
C0456389 (UMLS CUI [1,2])
C1301886 (UMLS CUI [2])
CL Item
Left abdomen (1)
CL Item
Right abdomen (2)
CL Item
Other, specify (3)
Specify other location of injection
Item
Specify other location of injection
text
C2700396 (UMLS CUI [1])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
Was this local reaction within 24 hrs of dose?
Item
Was this local reaction within 24 hrs of dose?
boolean
C0853813 (UMLS CUI [1])
C0178602 (UMLS CUI [2])
C0178602 (UMLS CUI [2])
Item
Check all that apply regarding local reaction symptoms:
integer
C1457887 (UMLS CUI [1,1])
C0853813 (UMLS CUI [1,2])
C0853813 (UMLS CUI [1,2])
Code List
Check all that apply regarding local reaction symptoms:
CL Item
Redness/ Erythema Mild (1)
CL Item
Redness/ Erythema Moderate (2)
CL Item
Redness/ Erythema Severe (3)
CL Item
Itching/ Prutitus Mild (4)
CL Item
Itching/ Prutitus Moderate (5)
CL Item
Itching/ Prutitus Severe (6)
CL Item
Raised Mild (7)
CL Item
Raised Moderate (8)
CL Item
Raised Severe (9)
CL Item
Warmth Mild (10)
CL Item
Warmth Moderate (11)
CL Item
Warmth Severe (12)
CL Item
Other symptoms Mild (13)
CL Item
Other symptoms Moderate (14)
CL Item
Other symptoms Severe (15)
Specify other symptoms
Item
Specify other symptoms
text
C1457887 (UMLS CUI [1])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
Was treatment given for this local reaction?
Item
Was treatment given for this local reaction?
boolean
C0853813 (UMLS CUI [1])
C0087111 (UMLS CUI [2])
C0087111 (UMLS CUI [2])
Serum sample obtained?
Item
Serum sample obtained?
boolean
C0229671 (UMLS CUI [1])
C0200345 (UMLS CUI [2])
C0200345 (UMLS CUI [2])
Provide date sample obtained
Item
Provide date sample obtained
date
C1302413 (UMLS CUI [1])
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