ID
35375
Description
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
Mots-clés
Versions (2)
- 04/03/2019 04/03/2019 -
- 30/10/2019 30/10/2019 - Sarah Riepenhausen
Détendeur de droits
GlaxoSmithKline
Téléchargé le
4 mars 2019
DOI
Pour une demande vous connecter.
Licence
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
Description
Visit Date
Alias
- UMLS CUI-1
- C1320303
Description
Was a physical examination performed?
Alias
- UMLS CUI-1
- C0031809
Description
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Description
Clinical Assessment
Type de données
integer
Alias
- UMLS CUI [1]
- C4534461
Description
If other Clinical Assessment, please specify
Type de données
text
Alias
- UMLS CUI [1,1]
- C4534461
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Description
Check one box only
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0243095
Description
If clinically significant, please record on the adverse event page
Type de données
text
Alias
- UMLS CUI [1,1]
- C0348080
- UMLS CUI [1,2]
- C0205161
- UMLS CUI [1,3]
- C2348235
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
If Yes, complete below
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C1516048
Description
Date of assessment
Type de données
date
Alias
- UMLS CUI [1]
- C2985720
Description
Check one box only
Type de données
integer
Alias
- UMLS CUI [1]
- C1262869
Description
Systolic BP
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic BP
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Heart Rate
Type de données
integer
Unités de mesure
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Description
Respiration Rate
Type de données
integer
Unités de mesure
- breaths/min
Alias
- UMLS CUI [1]
- C0231832
Description
Temperature
Type de données
float
Alias
- UMLS CUI [1]
- C0005903
Description
Check one box only
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C1519795
Description
Weight
Type de données
float
Alias
- UMLS CUI [1]
- C0005910
Description
Check one box only
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0005910
- UMLS CUI [1,2]
- C0439148
Description
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Description
Was a 12-lead ECG performed?
Type de données
boolean
Alias
- UMLS CUI [1]
- C0430456
Description
Date of ECG
Type de données
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0011008
Description
Check one box only
Type de données
integer
Alias
- UMLS CUI [1]
- C1262869
Description
ECG Results
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C1274040
Description
Ventriculat rate
Type de données
integer
Unités de mesure
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Description
PR Interval
Type de données
integer
Unités de mesure
- msec
Alias
- UMLS CUI [1]
- C0429087
Description
QRS Duration
Type de données
integer
Unités de mesure
- msec
Alias
- UMLS CUI [1]
- C0429025
Description
QT
Type de données
integer
Unités de mesure
- msec
Alias
- UMLS CUI [1]
- C1287082
Description
QTc
Type de données
integer
Unités de mesure
- msec
Alias
- UMLS CUI [1]
- C0489625
Description
QTc Formula
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1882512
- UMLS CUI [1,2]
- C1882513
Description
ECG Findings
Alias
- UMLS CUI-1
- C0438154
Description
Hematology
Alias
- UMLS CUI-1
- C0474523
Description
If No, or if results are not available, please complete details on the comments page or the protocol deviations page.
Type de données
boolean
Alias
- UMLS CUI [1]
- C0200345
Description
Date and time of sample
Type de données
datetime
Alias
- UMLS CUI [1]
- C1302413
- UMLS CUI [2,1]
- C0040223
- UMLS CUI [2,2]
- C0200345
Description
(if different from main hospital laboratory)
Type de données
text
Alias
- UMLS CUI [1]
- C3258037
Description
Hematology
Alias
- UMLS CUI-1
- C0474523
Description
Parameter
Type de données
integer
Alias
- UMLS CUI [1]
- C0549193
Description
Result
Type de données
text
Alias
- UMLS CUI [1]
- C1274040
Description
Units
Type de données
text
Alias
- UMLS CUI [1]
- C1519795
Description
Check one box only. If any result is clinically significant, please record a diagnosis on the adverse event page.
Type de données
integer
Alias
- UMLS CUI [1]
- C0243095
Description
Not Done
Type de données
integer
Alias
- UMLS CUI [1]
- C1272696
Description
Clinical Chemistry, Coagulation and Electrolytes
Alias
- UMLS CUI-1
- C0008000
- UMLS CUI-2
- C0005778
- UMLS CUI-3
- C0013832
Description
If No, or if results are not available, please complete details on the comments page or the protocol deviations page.
Type de données
boolean
Alias
- UMLS CUI [1]
- C0200345
Description
Date and time of sample
Type de données
datetime
Alias
- UMLS CUI [1]
- C1302413
- UMLS CUI [2,1]
- C0040223
- UMLS CUI [2,2]
- C0200345
Description
(if different from main hospital laboratory)
Type de données
text
Alias
- UMLS CUI [1]
- C3258037
Description
Clinical Chemistry, Coagulation and Electrolytes
Alias
- UMLS CUI-1
- C0008000
- UMLS CUI-2
- C0005778
- UMLS CUI-3
- C0013832
Description
Parameter
Type de données
integer
Alias
- UMLS CUI [1]
- C0549193
Description
Results
Type de données
text
Alias
- UMLS CUI [1]
- C1254595
Description
Units
Type de données
text
Alias
- UMLS CUI [1]
- C1519795
Description
Check one box only. If any result is clinically significant, please record a diagnosis on the adverse event page.
Type de données
integer
Alias
- UMLS CUI [1]
- C0243095
Description
Not Done
Type de données
integer
Alias
- UMLS CUI [1]
- C1272696
Description
Urinalysis dipstick results
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C0430370
- UMLS CUI-3
- C1274040
Description
If No, or if results are not available, please complete details on the comments page or the protocol deviations page.
Type de données
boolean
Alias
- UMLS CUI [1]
- C0200345
Description
Date of sample
Type de données
date
Alias
- UMLS CUI [1]
- C1302413
Description
Time of sample
Type de données
time
Alias
- UMLS CUI [1]
- C4064021
Description
(if different from main hospital laboratory)
Type de données
text
Alias
- UMLS CUI [1]
- C3258037
Description
pH
Type de données
integer
Alias
- UMLS CUI [1]
- C0042044
Description
If other pH, please specify
Type de données
text
Alias
- UMLS CUI [1,1]
- C0042044
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Description
Glucose
Type de données
integer
Alias
- UMLS CUI [1]
- C0004076
Description
If other Glucose, please specify
Type de données
text
Alias
- UMLS CUI [1,1]
- C0004076
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Description
Blood
Type de données
integer
Alias
- UMLS CUI [1]
- C0018965
Description
If other Blood, please specify
Type de données
text
Alias
- UMLS CUI [1,1]
- C0018965
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Description
Protein
Type de données
integer
Alias
- UMLS CUI [1]
- C0262923
Description
If other Protein, please specify.
Type de données
text
Alias
- UMLS CUI [1,1]
- C0262923
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Description
Leucocytes
Type de données
integer
Alias
- UMLS CUI [1]
- C1256582
Description
If other Leucocytes, please specify.
Type de données
text
Alias
- UMLS CUI [1,1]
- C1256582
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Description
Urinalysis microscopy results
Alias
- UMLS CUI-1
- C0430397
- UMLS CUI-2
- C1274040
Description
Check one box only. If No, or if results are not available, please complete details on the comments page or the protocol deviations page.
Type de données
integer
Alias
- UMLS CUI [1]
- C0200345
Description
Date of sample
Type de données
date
Alias
- UMLS CUI [1]
- C1302413
Description
Time of sample
Type de données
time
Alias
- UMLS CUI [1]
- C4064021
Description
If different from main hospital laboratory
Type de données
text
Alias
- UMLS CUI [1]
- C3258037
Description
Urinalysis microscopy results
Alias
- UMLS CUI-1
- C0430397
- UMLS CUI-2
- C1274040
Description
Parameter
Type de données
integer
Alias
- UMLS CUI [1]
- C0549193
Description
Result
Type de données
text
Alias
- UMLS CUI [1]
- C1274040
Description
Units
Type de données
text
Alias
- UMLS CUI [1]
- C1519795
Description
Not Done
Type de données
integer
Alias
- UMLS CUI [1]
- C1272696
Description
Clinically significant?
Type de données
boolean
Alias
- UMLS CUI [1]
- C2826293
Description
Serum beta-hCG Pregnancy Test
Alias
- UMLS CUI-1
- C0430060
Description
If Yes, complete below
Type de données
boolean
Alias
- UMLS CUI [1]
- C1960468
Description
If a serum β-hCG pregnancy test has been performed please give details.
Type de données
boolean
Alias
- UMLS CUI [1]
- C0430060
Description
Date of pregnancy test
Type de données
date
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C0011008
Description
Check one box only
Type de données
integer
Alias
- UMLS CUI [1]
- C0427777
Description
PK Sampling - Plasma Samples
Alias
- UMLS CUI-1
- C0031327
- UMLS CUI-2
- C1277698
- UMLS CUI-3
- C1609077
Description
Check if Not Applicable
Type de données
integer
Alias
- UMLS CUI [1]
- C1272460
Description
Date of Sampling
Type de données
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0870078
Description
Time of Sampling
Type de données
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0870078
Description
Check if Not Done
Type de données
integer
Alias
- UMLS CUI [1]
- C1272696
Description
Study Treatment Compliance (Return)
Alias
- UMLS CUI-1
- C1321605
Description
If No, please complete the comments page or the protocol deviations page.
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C3890583
- UMLS CUI [1,2]
- C0332156
Description
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.
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1321605
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C0178602
Description
No. of missed dates:
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1705492
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0237753
Description
Dates dose missed:
Type de données
text
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1705492
- UMLS CUI [1,3]
- C0178602
Description
New Adverse Events and Concomitant Treatment
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C2347852
Description
If Yes, please record details on Adverse Events page.
Type de données
boolean
Alias
- UMLS CUI [1]
- C2347852
Description
If Yes, please record details on Concomitant Treatment page.
Type de données
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
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
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])