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ID
38700
Beschrijving
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
Trefwoorden
Versies (2)
- 04-03-19 04-03-19 -
- 30-10-19 30-10-19 - Sarah Riepenhausen
Houder van rechten
GlaxoSmithKline
Geüploaded op
30 oktober 2019
DOI
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Licentie
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
Cycle 1 Day 21 - Physical Examination; Vital Signs; 12-Lead ECG; Hematology; Clinical Chemistry, Coagulation and Electrolytes; Urinalysis; Urinalysis microscopy results; Serum beta-hCG Pregnancy Test; PK Sampling - Plasma Samples; Study Treatment Compliance (Return); New Adverse Events and Concomitant Treatment
Similar models
Cycle 1 Day 21 - Physical Examination; Vital Signs; 12-Lead ECG; Hematology; Clinical Chemistry, Coagulation and Electrolytes; Urinalysis; Urinalysis microscopy results; Serum beta-hCG Pregnancy Test; PK Sampling - Plasma Samples; Study Treatment Compliance (Return); New Adverse Events and Concomitant Treatment
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item Group
Was a physical examination performed?
C0031809 (UMLS CUI-1)
Was a physical examination performed?
Item
Was a physical examination performed?
boolean
C0031809 (UMLS CUI [1])
Date of Physical Examination
Item
Date of Physical Examination
date
C2826643 (UMLS CUI [1])
CL Item
General Appearance (1)
CL Item
Musculoskeletal (2)
CL Item
Skin and Mucosa (3)
CL Item
Head and Neck (4)
CL Item
Lymphatic (5)
CL Item
Respiratory (6)
CL Item
Breasts (7)
CL Item
Gastrointestinal (8)
CL Item
Cardiovascular (9)
CL Item
Extremities (10)
CL Item
Neurological (11)
CL Item
Psychological (12)
CL Item
Genitourinary (13)
CL Item
Rectal (14)
CL Item
Eyes,ears,nose & throat (15)
CL Item
Other (specify) (99)
If other Clinical Assessment, please specify
Item
If other Clinical Assessment, please specify.
text
C4534461 (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
Physical Findings
integer
C0031809 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,2])
CL Item
Not Done (1)
CL Item
Unchanged (2)
CL Item
If changed, normal (3)
CL Item
If changed, abnormal (4)
Please specify Abnormal conditions
Item
Please specify Abnormal conditions
text
C0348080 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205161 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
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 a 12-lead ECG performed?
Item
Was a 12-lead ECG performed?
boolean
C0430456 (UMLS CUI [1])
Date of ECG
Item
Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
CL Item
Sitting (1)
CL Item
Standing (2)
CL Item
Supine (3)
Ventriculat rate
Item
Ventriculat rate
integer
C0018810 (UMLS CUI [1])
PR Interval
Item
PR Interval
integer
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
integer
C0429025 (UMLS CUI [1])
QT
Item
QT
integer
C1287082 (UMLS CUI [1])
QTc
Item
QTc
integer
C0489625 (UMLS CUI [1])
CL Item
Bazett (1)
CL Item
Fridericia (2)
CL Item
Normal (1)
CL Item
Abnormal; not clinically significant (2)
CL Item
Abnormal; clinically significant (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])
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])
Is the subject female of child-bearing potential?
Item
Is the subject female of child-bearing potential?
boolean
C1960468 (UMLS CUI [1])
Has a serum β-hCG pregnancy test been performed?
Item
Has a serum β-hCG pregnancy test been performed?
boolean
C0430060 (UMLS CUI [1])
Date of pregnancy test
Item
Date of pregnancy test
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
CL Item
Negative (1)
CL Item
Positive (2)
Item Group
PK Sampling - Plasma Samples
C0031327 (UMLS CUI-1)
C1277698 (UMLS CUI-2)
C1609077 (UMLS CUI-3)
C1277698 (UMLS CUI-2)
C1609077 (UMLS CUI-3)
CL Item
Not Applicable (1)
Date of Sampling
Item
Date of Sampling
date
C0011008 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,2])
Time of Sampling
Item
Time of Sampling
time
C0040223 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,2])
CL Item
Not Done (1)
Item Group
Study Treatment Compliance (Return)
C1321605 (UMLS CUI-1)
Has the subject been issued with a diary card?
Item
Has the subject returned their diary card?
boolean
C3890583 (UMLS CUI [1,1])
C0332156 (UMLS CUI [1,2])
C0332156 (UMLS CUI [1,2])
Has the subject been compliant with dosing of study drug?
Item
Has the subject received SRT501 approximately 15-30 minutes following breakfast consumption?
boolean
C1321605 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
No. of missed dates:
Item
No. of missed dates:
integer
C1705492 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Dates dose missed:
Item
Dates dose missed:
text
C0011008 (UMLS CUI [1,1])
C1705492 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C1705492 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
Item Group
New Adverse Events and Concomitant Treatment
C0877248 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C2347852 (UMLS CUI-2)
Has the subject experienced any new adverse events or worsening of an existing adverse event or condition prior to this visit?
Item
Has the subject experienced any new adverse events or worsening of an existing adverse event or condition prior to this visit?
boolean
C2347852 (UMLS CUI [1])
Has the subject started any new concomitant treatment or increased/decreased dosing/frequency of any existing concomitant medications prior to this visit?
Item
Has the subject started any new concomitant treatment or increased/decreased dosing/frequency of any existing concomitant medications prior to this visit?
boolean
C2347852 (UMLS CUI [1])
C0678766 (UMLS CUI [2,1])
C0205217 (UMLS CUI [2,2])
C0678766 (UMLS CUI [3,1])
C0205216 (UMLS CUI [3,2])
C0439603 (UMLS CUI [4,1])
C0205217 (UMLS CUI [4,2])
C0439603 (UMLS CUI [5,1])
C0205216 (UMLS CUI [5,2])
C0678766 (UMLS CUI [2,1])
C0205217 (UMLS CUI [2,2])
C0678766 (UMLS CUI [3,1])
C0205216 (UMLS CUI [3,2])
C0439603 (UMLS CUI [4,1])
C0205217 (UMLS CUI [4,2])
C0439603 (UMLS CUI [5,1])
C0205216 (UMLS CUI [5,2])