0 Évaluations

ID

41629

Description

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

Mots-clés

Injektionen, subkutane

End of Study

Endokrines System

Klinische Studie [Dokumenttyp]

Simvastatin

Diabetes mellitus, Typ 2

16.11.20 16.11.20 -
29.11.20 29.11.20 -

Détendeur de droits

GlaxoSmithKline

Téléchargé le

29. November 2020

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692

model
Détails

Study Completion; Unscheduled Visit; Hypoglycaemia; Injection Site Reaction

1 Formulaires

StudyEvent: ODM
1. Study Completion; Unscheduled Visit; Hypoglycaemia; Injection Site Reaction

Name

Type

Description | Question | Decode (Coded Value)

Type de données

Alias

Administrative

Item Group

Administrative

C1320722 (UMLS CUI-1)

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])

Visit Date

Item

Visit Date

date

C1320303 (UMLS CUI [1])

Study Completion

Item Group

Study Completion

C0008976 (UMLS CUI-1)
C0444930 (UMLS CUI-2)

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])

If subject did not complete the study, mark ONE reason

Item

If subject did not complete the study, mark ONE reason

integer

C3827242 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])

If subject did not complete the study, mark ONE reason

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])

Specify AE No (Adverse event)

Item

Specify AE No (Adverse event)

integer

C0877248 (UMLS CUI [1,1])
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])

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])

Comments

Item

Comments

text

C0947611 (UMLS CUI [1])

Vital Signs (Unscheduled)

Item Group

Vital Signs (Unscheduled)

C0518766 (UMLS CUI-1)
C3854240 (UMLS CUI-2)

Vital Signs - Repeat or Unscheduled?

Item

Vital Signs - Repeat or Unscheduled?

integer

C0518766 (UMLS CUI [1])
C0205341 (UMLS CUI [2])
C3854240 (UMLS CUI [3])

Repeat or Unscheduled?

Code List

Vital Signs - Repeat or Unscheduled?

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])

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])

Vital Signs - Body Position

Item

Vital Signs - Body Position

integer

C0518766 (UMLS CUI [1,1])
C1262869 (UMLS CUI [1,2])

Body Position

Code List

Vital Signs - Body Position

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])

Physical Examination (Unscheduled Visit)

Item Group

Physical Examination (Unscheduled Visit)

C0031809 (UMLS CUI-1)
C3854240 (UMLS CUI-2)

Date of Physical Exam

Item

Date of Physical Exam

date

C2826643 (UMLS CUI [1])

Assessment

Item

Assessment

integer

C2911685 (UMLS CUI [1])

Assessment

Code List

Assessment

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)

Electrocardiogram (Unscheduled)

Item Group

Electrocardiogram (Unscheduled)

C0013798 (UMLS CUI-1)
C3854240 (UMLS CUI-2)

Electrocardiogram - Repeat or Unscheduled?

Item

Electrocardiogram - Repeat or Unscheduled?

integer

C0013798 (UMLS CUI [1])
C0205341 (UMLS CUI [2])
C3854240 (UMLS CUI [3])

Electrocardiogram - Repeat or Unscheduled?

Code List

Electrocardiogram - Repeat or Unscheduled?

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])

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])

Electrocardiogram - Heart Rate

Item

Electrocardiogram - Heart Rate

integer

C0013798 (UMLS CUI [1])
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])

Electrocardiogram - QT Interval

Item

Electrocardiogram - QT Interval

integer

C0013798 (UMLS CUI [1,1])
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])

Electrocardiogram - Q-TcF Interval

Item

Electrocardiogram - Q-TcF Interval

integer

C0429087 (UMLS CUI [1,1])
C1882513 (UMLS CUI [1,2])

Electrocardiogram - RR Interval

Item

Electrocardiogram - RR Interval

integer

C0013798 (UMLS CUI [1,1])
C0489636 (UMLS CUI [1,2])

Electrocardiogram - Normal Sinus Rhythm?

Item

Electrocardiogram - Normal Sinus Rhythm?

boolean

C1960147 (UMLS CUI [1])

Overall Interpretation of ECG

Item

Overall Interpretation of ECG

integer

C1623258 (UMLS CUI [1,1])
C0459471 (UMLS CUI [1,2])

Overall Interpretation of ECG

Code List

Overall Interpretation of ECG

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])

Central Laboratory Blood (Unscheduled)

Item Group

Central Laboratory Blood (Unscheduled)

C1880016 (UMLS CUI-1)
C3854240 (UMLS CUI-2)
C0005767 (UMLS CUI-3)

Central Laboratory Blood

Item

Central Laboratory Blood

integer

C1880016 (UMLS CUI [1])
C0005767 (UMLS CUI [2])

Central Laboratory

Code List

Central Laboratory Blood

CL Item

Haematology (1)

CL Item

Chemistry (2)

CL Item

Serology (3)

CL Item

Serum HCG (4)

CL Item

SP Chem (5)

Central Laboratory Blood - Repeat or Unscheduled?

Item

Central Laboratory Blood - Repeat or Unscheduled?

integer

C0205341 (UMLS CUI [1])
C0005767 (UMLS CUI [2])
C3854240 (UMLS CUI [3])

Repeat or Unscheduled?

Code List

Central Laboratory Blood - Repeat or Unscheduled?

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])

Central Laboratory Blood - Sample Date

Item

Central Laboratory Blood - Sample Date

date

C1880016 (UMLS CUI [1])
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])

Central Laboratory Blood - Comment

Item

Central Laboratory Blood - Comment

text

C1880016 (UMLS CUI [1])
C0005767 (UMLS CUI [2])
C0947611 (UMLS CUI [3])

Central Laboratory Urine (Unscheduled)

Item Group

Central Laboratory Urine (Unscheduled)

C1880016 (UMLS CUI-1)
C3854240 (UMLS CUI-2)
C0042036 (UMLS CUI-3)

Central Laboratory Urine

Item

Central Laboratory Urine

integer

C1880016 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])

Central Laboratory Urine

Code List

Central Laboratory Urine

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])

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])

Central Laboratory Urine - Sample Date

Item

Central Laboratory Urine - Sample Date

date

C1880016 (UMLS CUI [1])
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])

Central Laboratory Urine - Comment

Item

Central Laboratory Urine - Comment

text

C1880016 (UMLS CUI [1])
C0042036 (UMLS CUI [2])
C0947611 (UMLS CUI [3])

Hypoglycaemia

Item Group

Hypoglycaemia

C0020615 (UMLS CUI-1)

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])

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])

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])

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])

Frequency

Item

Frequency

integer

C0439603 (UMLS CUI [1])

Frequency

Code List

Frequency

CL Item

Single episode (1)

CL Item

Intermittent (2)

Severity of hypoglycaemic event: (per ADA working group guidelines)

Item

Severity of hypoglycaemic event: (per ADA working group guidelines)

integer

C1710066 (UMLS CUI [1])
C0745153 (UMLS CUI [2])

Severity of hypoglycaemic event: (per ADA working group guidelines)

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)

If Severe (at least one must be checked to fit the ADA criterion of severe), check all that apply:

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])

If Severe (at least one must be checked to fit the ADA criterion of severe), check all that apply:

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])

Intervention (enter the most severe, enter details on concomitant medication page if applicable)

Item

Intervention (enter the most severe, enter details on concomitant medication page if applicable)

integer

C0184661 (UMLS CUI [1])

Intervention (enter the most severe, enter details on concomitant medication page if applicable)

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)

Action Taken with Background or Anti-Hyperglycemic Medication?

Item

Action Taken with Background or Anti-Hyperglycemic Medication?

integer

C2826626 (UMLS CUI [1])

Action Taken with Background or Anti-Hyperglycemic Medication?

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)

Injection Site Reaction

Item Group

Injection Site Reaction

C0151735 (UMLS CUI-1)

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])

Date of injection

Item

Date of injection

date

C0011008 (UMLS CUI [1,1])
C0021485 (UMLS CUI [1,2])

Date of Reaction

Item

Date of Reaction

date

C0443286 (UMLS CUI [1,1])
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])

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])

Location of injection

Item

Location of injection

integer

C2700396 (UMLS CUI [1])

Location of injection

Code List

Location of injection

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])

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])

Check all that apply regarding local reaction symptoms:

Item

Check all that apply regarding local reaction symptoms:

integer

C1457887 (UMLS CUI [1,1])
C0853813 (UMLS CUI [1,2])

Check all that apply regarding local reaction symptoms:

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])

Was treatment given for this local reaction?

Item

Was treatment given for this local reaction?

boolean

C0853813 (UMLS CUI [1])
C0087111 (UMLS CUI [2])

Serum sample obtained?

Item

Serum sample obtained?

boolean

C0229671 (UMLS CUI [1])
C0200345 (UMLS CUI [2])

Provide date sample obtained

Item

Provide date sample obtained

date

C1302413 (UMLS CUI [1])

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ID

Description

Mots-clés

Versions (2)

Détendeur de droits

Téléchargé le

DOI

Licence

Modèle Commentaires :

Groupe Item commentaires pour :

Item commentaires pour :

Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692

Study Completion; Unscheduled Visit; Hypoglycaemia; Injection Site Reaction

Description

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