ID
38700
Beschreibung
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
Stichworte
Versionen (2)
- 04.03.19 04.03.19 -
- 30.10.19 30.10.19 - Sarah Riepenhausen
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
30. Oktober 2019
DOI
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Lizenz
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
Beschreibung
Visit Date
Alias
- UMLS CUI-1
- C1320303
Beschreibung
Was a physical examination performed?
Alias
- UMLS CUI-1
- C0031809
Beschreibung
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Beschreibung
Clinical Assessment
Datentyp
integer
Alias
- UMLS CUI [1]
- C4534461
Beschreibung
If other Clinical Assessment, please specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C4534461
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschreibung
Check one box only
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0243095
Beschreibung
If clinically significant, please record on the adverse event page
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0348080
- UMLS CUI [1,2]
- C0205161
- UMLS CUI [1,3]
- C2348235
Beschreibung
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschreibung
If Yes, complete below
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C1516048
Beschreibung
Date of assessment
Datentyp
date
Alias
- UMLS CUI [1]
- C2985720
Beschreibung
Check one box only
Datentyp
integer
Alias
- UMLS CUI [1]
- C1262869
Beschreibung
Systolic BP
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschreibung
Diastolic BP
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschreibung
Heart Rate
Datentyp
integer
Maßeinheiten
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beschreibung
Respiration Rate
Datentyp
integer
Maßeinheiten
- breaths/min
Alias
- UMLS CUI [1]
- C0231832
Beschreibung
Temperature
Datentyp
float
Alias
- UMLS CUI [1]
- C0005903
Beschreibung
Check one box only
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C1519795
Beschreibung
Weight
Datentyp
float
Alias
- UMLS CUI [1]
- C0005910
Beschreibung
Check one box only
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0005910
- UMLS CUI [1,2]
- C0439148
Beschreibung
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Beschreibung
Was a 12-lead ECG performed?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0430456
Beschreibung
Date of ECG
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0011008
Beschreibung
Check one box only
Datentyp
integer
Alias
- UMLS CUI [1]
- C1262869
Beschreibung
ECG Results
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C1274040
Beschreibung
Ventriculat rate
Datentyp
integer
Maßeinheiten
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beschreibung
PR Interval
Datentyp
integer
Maßeinheiten
- msec
Alias
- UMLS CUI [1]
- C0429087
Beschreibung
QRS Duration
Datentyp
integer
Maßeinheiten
- msec
Alias
- UMLS CUI [1]
- C0429025
Beschreibung
QT
Datentyp
integer
Maßeinheiten
- msec
Alias
- UMLS CUI [1]
- C1287082
Beschreibung
QTc
Datentyp
integer
Maßeinheiten
- msec
Alias
- UMLS CUI [1]
- C0489625
Beschreibung
QTc Formula
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1882512
- UMLS CUI [1,2]
- C1882513
Beschreibung
ECG Findings
Alias
- UMLS CUI-1
- C0438154
Beschreibung
Hematology
Alias
- UMLS CUI-1
- C0474523
Beschreibung
If No, or if results are not available, please complete details on the comments page or the protocol deviations page.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0200345
Beschreibung
Date and time of sample
Datentyp
datetime
Alias
- UMLS CUI [1]
- C1302413
- UMLS CUI [2,1]
- C0040223
- UMLS CUI [2,2]
- C0200345
Beschreibung
(if different from main hospital laboratory)
Datentyp
text
Alias
- UMLS CUI [1]
- C3258037
Beschreibung
Hematology
Alias
- UMLS CUI-1
- C0474523
Beschreibung
Parameter
Datentyp
integer
Alias
- UMLS CUI [1]
- C0549193
Beschreibung
Result
Datentyp
text
Alias
- UMLS CUI [1]
- C1274040
Beschreibung
Units
Datentyp
text
Alias
- UMLS CUI [1]
- C1519795
Beschreibung
Check one box only. If any result is clinically significant, please record a diagnosis on the adverse event page.
Datentyp
integer
Alias
- UMLS CUI [1]
- C0243095
Beschreibung
Not Done
Datentyp
integer
Alias
- UMLS CUI [1]
- C1272696
Beschreibung
Clinical Chemistry, Coagulation and Electrolytes
Alias
- UMLS CUI-1
- C0008000
- UMLS CUI-2
- C0005778
- UMLS CUI-3
- C0013832
Beschreibung
If No, or if results are not available, please complete details on the comments page or the protocol deviations page.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0200345
Beschreibung
Date and time of sample
Datentyp
datetime
Alias
- UMLS CUI [1]
- C1302413
- UMLS CUI [2,1]
- C0040223
- UMLS CUI [2,2]
- C0200345
Beschreibung
(if different from main hospital laboratory)
Datentyp
text
Alias
- UMLS CUI [1]
- C3258037
Beschreibung
Clinical Chemistry, Coagulation and Electrolytes
Alias
- UMLS CUI-1
- C0008000
- UMLS CUI-2
- C0005778
- UMLS CUI-3
- C0013832
Beschreibung
Parameter
Datentyp
integer
Alias
- UMLS CUI [1]
- C0549193
Beschreibung
Results
Datentyp
text
Alias
- UMLS CUI [1]
- C1254595
Beschreibung
Units
Datentyp
text
Alias
- UMLS CUI [1]
- C1519795
Beschreibung
Check one box only. If any result is clinically significant, please record a diagnosis on the adverse event page.
Datentyp
integer
Alias
- UMLS CUI [1]
- C0243095
Beschreibung
Not Done
Datentyp
integer
Alias
- UMLS CUI [1]
- C1272696
Beschreibung
Urinalysis dipstick results
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C0430370
- UMLS CUI-3
- C1274040
Beschreibung
If No, or if results are not available, please complete details on the comments page or the protocol deviations page.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0200345
Beschreibung
Date of sample
Datentyp
date
Alias
- UMLS CUI [1]
- C1302413
Beschreibung
Time of sample
Datentyp
time
Alias
- UMLS CUI [1]
- C4064021
Beschreibung
(if different from main hospital laboratory)
Datentyp
text
Alias
- UMLS CUI [1]
- C3258037
Beschreibung
pH
Datentyp
integer
Alias
- UMLS CUI [1]
- C0042044
Beschreibung
If other pH, please specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0042044
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschreibung
Glucose
Datentyp
integer
Alias
- UMLS CUI [1]
- C0004076
Beschreibung
If other Glucose, please specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0004076
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschreibung
Blood
Datentyp
integer
Alias
- UMLS CUI [1]
- C0018965
Beschreibung
If other Blood, please specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0018965
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschreibung
Protein
Datentyp
integer
Alias
- UMLS CUI [1]
- C0262923
Beschreibung
If other Protein, please specify.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0262923
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschreibung
Leucocytes
Datentyp
integer
Alias
- UMLS CUI [1]
- C1256582
Beschreibung
If other Leucocytes, please specify.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1256582
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschreibung
Urinalysis microscopy results
Alias
- UMLS CUI-1
- C0430397
- UMLS CUI-2
- C1274040
Beschreibung
Check one box only. If No, or if results are not available, please complete details on the comments page or the protocol deviations page.
Datentyp
integer
Alias
- UMLS CUI [1]
- C0200345
Beschreibung
Date of sample
Datentyp
date
Alias
- UMLS CUI [1]
- C1302413
Beschreibung
Time of sample
Datentyp
time
Alias
- UMLS CUI [1]
- C4064021
Beschreibung
If different from main hospital laboratory
Datentyp
text
Alias
- UMLS CUI [1]
- C3258037
Beschreibung
Urinalysis microscopy results
Alias
- UMLS CUI-1
- C0430397
- UMLS CUI-2
- C1274040
Beschreibung
Parameter
Datentyp
integer
Alias
- UMLS CUI [1]
- C0549193
Beschreibung
Result
Datentyp
text
Alias
- UMLS CUI [1]
- C1274040
Beschreibung
Units
Datentyp
text
Alias
- UMLS CUI [1]
- C1519795
Beschreibung
Not Done
Datentyp
integer
Alias
- UMLS CUI [1]
- C1272696
Beschreibung
Clinically significant?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2826293
Beschreibung
Serum beta-hCG Pregnancy Test
Alias
- UMLS CUI-1
- C0430060
Beschreibung
If Yes, complete below
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1960468
Beschreibung
If a serum β-hCG pregnancy test has been performed please give details.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0430060
Beschreibung
Date of pregnancy test
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C0011008
Beschreibung
Check one box only
Datentyp
integer
Alias
- UMLS CUI [1]
- C0427777
Beschreibung
PK Sampling - Plasma Samples
Alias
- UMLS CUI-1
- C0031327
- UMLS CUI-2
- C1277698
- UMLS CUI-3
- C1609077
Beschreibung
Check if Not Applicable
Datentyp
integer
Alias
- UMLS CUI [1]
- C1272460
Beschreibung
Date of Sampling
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0870078
Beschreibung
Time of Sampling
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0870078
Beschreibung
Check if Not Done
Datentyp
integer
Alias
- UMLS CUI [1]
- C1272696
Beschreibung
Study Treatment Compliance (Return)
Alias
- UMLS CUI-1
- C1321605
Beschreibung
If No, please complete the comments page or the protocol deviations page.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C3890583
- UMLS CUI [1,2]
- C0332156
Beschreibung
If No, please provide the number of missed doses and the dates that the doses were missed. If No, please complete the comments page or the protocol deviations page.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1321605
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C0178602
Beschreibung
No. of missed dates:
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1705492
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0237753
Beschreibung
Dates dose missed:
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1705492
- UMLS CUI [1,3]
- C0178602
Beschreibung
New Adverse Events and Concomitant Treatment
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C2347852
Beschreibung
If Yes, please record details on Adverse Events page.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2347852
Beschreibung
If Yes, please record details on Concomitant Treatment page.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2347852
- UMLS CUI [2,1]
- C0678766
- UMLS CUI [2,2]
- C0205217
- UMLS CUI [3,1]
- C0678766
- UMLS CUI [3,2]
- C0205216
- UMLS CUI [4,1]
- C0439603
- UMLS CUI [4,2]
- C0205217
- UMLS CUI [5,1]
- C0439603
- UMLS CUI [5,2]
- C0205216
Ähnliche Modelle
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
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0243095 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C1516048 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [2,1])
C0200345 (UMLS CUI [2,2])
C0005778 (UMLS CUI-2)
C0013832 (UMLS CUI-3)
C0040223 (UMLS CUI [2,1])
C0200345 (UMLS CUI [2,2])
C0005778 (UMLS CUI-2)
C0013832 (UMLS CUI-3)
C0430370 (UMLS CUI-2)
C1274040 (UMLS CUI-3)
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C1274040 (UMLS CUI-2)
C1274040 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
C1277698 (UMLS CUI-2)
C1609077 (UMLS CUI-3)
C0870078 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,2])
C0332156 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C1705492 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C2347852 (UMLS CUI-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])