Information:
Fel:
ID
35539
Beskrivning
Study ID: 113222 Clinical Study ID: 113222 Study Title: A Phase II, Open Label, Clinical Study to Assess the Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00920556 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name:5.0g SRT501 Trade Name: Bortezomib Study Indication: Multiple Myeloma
Nyckelord
Versioner (1)
- 2019-03-07 2019-03-07 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
7 mars 2019
DOI
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Licens
Creative Commons BY-NC 3.0
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Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma NCT00920556
SRT501 + Bortezomib Cycle __ Day 1 (Pre Dose) - Vital Signs; Hematology; Clinical Chemistry, Coagulation and Electrolytes; Urinalysis; Urinalysis microscopy results; Bortezomib Administration
Similar models
SRT501 + Bortezomib Cycle __ Day 1 (Pre Dose) - Vital Signs; Hematology; Clinical Chemistry, Coagulation and Electrolytes; Urinalysis; Urinalysis microscopy results; Bortezomib Administration
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Were vital signs assessed?
Item
Were vital signs assessed?
boolean
C0518766 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,2])
Date of assessment
Item
Date of assessment
date
C2985720 (UMLS CUI [1])
CL Item
Sitting (1)
CL Item
Standing (2)
CL Item
Supine (3)
Systolic BP
Item
Systolic BP
integer
C0871470 (UMLS CUI [1])
Diastolic BP
Item
Diastolic BP
integer
C0428883 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Respiration Rate
Item
Respiration Rate
integer
C0231832 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
CL Item
°C (1)
CL Item
°F (2)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
CL Item
kg (1)
CL Item
lb (2)
Was sampling performed?
Item
Was sampling performed?
boolean
C0200345 (UMLS CUI [1])
Date and time of sample
Item
Date and time of sample
datetime
C1302413 (UMLS CUI [1])
C0040223 (UMLS CUI [2,1])
C0200345 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,1])
C0200345 (UMLS CUI [2,2])
Laboratory name:
Item
Laboratory name:
text
C3258037 (UMLS CUI [1])
CL Item
White blood cell (WBC) count (1)
CL Item
Hemoglobin (2)
CL Item
Hematocrit (3)
CL Item
Mean corpuscular haemoglobin concentration (MCHC) (4)
CL Item
Mean corpuscular hemoglobin (MCH) (5)
CL Item
Neutrophils (6)
CL Item
Lymphocytes (7)
CL Item
Monocytes (8)
CL Item
Eosinophils (9)
CL Item
Basinophils (10)
CL Item
Platelets (11)
CL Item
Mean corpuscular volume (MCV) (12)
CL Item
Red blood cell (RBC) count (13)
CL Item
Red blood cell distribution width (RDW) (14)
Result
Item
Result
text
C1274040 (UMLS CUI [1])
Units
Item
Units
text
C1519795 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal, not clinically significant (2)
CL Item
Abnormal, clinically significant (3)
CL Item
Not Done (1)
Item Group
Clinical Chemistry, Coagulation and Electrolytes
C0008000 (UMLS CUI-1)
C0005778 (UMLS CUI-2)
C0013832 (UMLS CUI-3)
C0005778 (UMLS CUI-2)
C0013832 (UMLS CUI-3)
Was sampling performed?
Item
Was sampling performed?
boolean
C0200345 (UMLS CUI [1])
Date and time of sample
Item
Date and time of sample
datetime
C1302413 (UMLS CUI [1])
C0040223 (UMLS CUI [2,1])
C0200345 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,1])
C0200345 (UMLS CUI [2,2])
Laboratory name:
Item
Laboratory name:
text
C3258037 (UMLS CUI [1])
Item Group
Clinical Chemistry, Coagulation and Electrolytes
C0008000 (UMLS CUI-1)
C0005778 (UMLS CUI-2)
C0013832 (UMLS CUI-3)
C0005778 (UMLS CUI-2)
C0013832 (UMLS CUI-3)
CL Item
Sodium (1)
CL Item
Potassium (2)
CL Item
Chloride (3)
CL Item
Serum creatinine (4)
CL Item
Glucose (5)
CL Item
Phosphate (6)
CL Item
Creatinine kinase (7)
CL Item
ALT (8)
CL Item
AST (9)
CL Item
Total bilirubin (10)
CL Item
Alkaline phosphatase (11)
CL Item
Calcium (12)
CL Item
Bicarbonate (13)
CL Item
Albumin (14)
CL Item
Urea (15)
CL Item
PT/INR (16)
Results
Item
Results
text
C1254595 (UMLS CUI [1])
Units
Item
Units
text
C1519795 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal, not clinically significant (2)
CL Item
Abnormal, clinically significant (3)
CL Item
Not Done (1)
Item Group
Urinalysis dipstick results
C0042014 (UMLS CUI-1)
C0430370 (UMLS CUI-2)
C1274040 (UMLS CUI-3)
C0430370 (UMLS CUI-2)
C1274040 (UMLS CUI-3)
Was sampling performed?
Item
Was sampling performed?
boolean
C0200345 (UMLS CUI [1])
Date of sample
Item
Date of sample
date
C1302413 (UMLS CUI [1])
Time of sample
Item
Time of sample
time
C4064021 (UMLS CUI [1])
Laboratory name:
Item
Laboratory name:
text
C3258037 (UMLS CUI [1])
CL Item
5.0 (1)
CL Item
6.0 (2)
CL Item
6.5 (3)
CL Item
7.0 (4)
CL Item
7.5 (5)
CL Item
8.0 (6)
CL Item
8.5 (7)
CL Item
Other, please specify (8)
CL Item
Not Done (9)
If other pH, please specify
Item
If other pH, please specify
text
C0042044 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
CL Item
Negative (0)
CL Item
Trace (1)
CL Item
+ 14 (2)
CL Item
++ 28 (3)
CL Item
+++ 55 (4)
CL Item
++++ >=111 (5)
CL Item
Other, please specify (6)
CL Item
Not Done (7)
If other Glucose, please specify
Item
If other Glucose, please specify
text
C0004076 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
CL Item
Negative (0)
CL Item
Non-haemolysed Trace (1)
CL Item
Haemolysed Trace (2)
CL Item
+ Small (3)
CL Item
++ Moderate (4)
CL Item
+++ Large (5)
CL Item
Other Blood, please specify (6)
CL Item
Not Done (7)
If other Blood, please specify
Item
If other Blood, please specify
text
C0018965 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
CL Item
Negative (0)
CL Item
Trace (1)
CL Item
+ 0.30 (2)
CL Item
++ 1 (3)
CL Item
+++ 3 (4)
CL Item
++++ >=20 (5)
CL Item
Other, please specify (6)
CL Item
Not Done (7)
If other Protein, please specify.
Item
If other Protein, please specify.
text
C0262923 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
CL Item
Negative (0)
CL Item
Trace (1)
CL Item
+ Small (2)
CL Item
++ Moderate (3)
CL Item
+++Large (4)
CL Item
Other, please specify (5)
CL Item
Not Done (6)
If other Leucocytes, please specify.
Item
If other Leucocytes, please specify.
text
C1256582 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Urinalysis microscopy results
C0430397 (UMLS CUI-1)
C1274040 (UMLS CUI-2)
C1274040 (UMLS CUI-2)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Applicable (3)
Date of sample
Item
Date of sample
date
C1302413 (UMLS CUI [1])
Time of sample
Item
Time of sample
time
C4064021 (UMLS CUI [1])
Laboratory name:
Item
Laboratory name:
text
C3258037 (UMLS CUI [1])
Item Group
Urinalysis microscopy results
C0430397 (UMLS CUI-1)
C1274040 (UMLS CUI-2)
C1274040 (UMLS CUI-2)
CL Item
RBC (1)
CL Item
WBC (2)
CL Item
Casts (3)
CL Item
Epithelial cells (4)
Result
Item
Result
text
C1274040 (UMLS CUI [1])
Units
Item
Units
text
C1519795 (UMLS CUI [1])
CL Item
Not Done (1)
Clinically significant?
Item
Clinically significant?
boolean
C2826293 (UMLS CUI [1])
Item Group
Bortezomib Administration
C1176309 (UMLS CUI-1)
C1533734 (UMLS CUI-2)
C1533734 (UMLS CUI-2)
Was bortezomib administered at this visit?
Item
Was bortezomib administered at this visit?
boolean
C1176309 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
C1533734 (UMLS CUI [1,2])
Date administered
Item
Date administered
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Lot #
Item
Lot #
integer
C1115660 (UMLS CUI [1])
Time Administered
Item
Time Administered
time
C1533734 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
Dose Level
Item
Dose Level
integer
C0178602 (UMLS CUI [1])
BSA
Item
BSA
integer
C0005902 (UMLS CUI [1])
Dose Admin
Item
Dose Admin
integer
C3174092 (UMLS CUI [1])