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
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
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
Beschrijving
Visit Date
Alias
- UMLS CUI-1
- C1320303
Beschrijving
Was a physical examination performed?
Alias
- UMLS CUI-1
- C0031809
Beschrijving
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Beschrijving
Clinical Assessment
Datatype
integer
Alias
- UMLS CUI [1]
- C4534461
Beschrijving
If other Clinical Assessment, please specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C4534461
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschrijving
Check one box only
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0243095
Beschrijving
If clinically significant, please record on the adverse event page
Datatype
text
Alias
- UMLS CUI [1,1]
- C0348080
- UMLS CUI [1,2]
- C0205161
- UMLS CUI [1,3]
- C2348235
Beschrijving
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschrijving
If Yes, complete below
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C1516048
Beschrijving
Date of assessment
Datatype
date
Alias
- UMLS CUI [1]
- C2985720
Beschrijving
Check one box only
Datatype
integer
Alias
- UMLS CUI [1]
- C1262869
Beschrijving
Systolic BP
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
Diastolic BP
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
Heart Rate
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
Respiration Rate
Datatype
integer
Maateenheden
- breaths/min
Alias
- UMLS CUI [1]
- C0231832
Beschrijving
Temperature
Datatype
float
Alias
- UMLS CUI [1]
- C0005903
Beschrijving
Check one box only
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C1519795
Beschrijving
Weight
Datatype
float
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Check one box only
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0005910
- UMLS CUI [1,2]
- C0439148
Beschrijving
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Beschrijving
Was a 12-lead ECG performed?
Datatype
boolean
Alias
- UMLS CUI [1]
- C0430456
Beschrijving
Date of ECG
Datatype
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0011008
Beschrijving
Check one box only
Datatype
integer
Alias
- UMLS CUI [1]
- C1262869
Beschrijving
ECG Results
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C1274040
Beschrijving
Ventriculat rate
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
PR Interval
Datatype
integer
Maateenheden
- msec
Alias
- UMLS CUI [1]
- C0429087
Beschrijving
QRS Duration
Datatype
integer
Maateenheden
- msec
Alias
- UMLS CUI [1]
- C0429025
Beschrijving
QT
Datatype
integer
Maateenheden
- msec
Alias
- UMLS CUI [1]
- C1287082
Beschrijving
QTc
Datatype
integer
Maateenheden
- msec
Alias
- UMLS CUI [1]
- C0489625
Beschrijving
QTc Formula
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1882512
- UMLS CUI [1,2]
- C1882513
Beschrijving
ECG Findings
Alias
- UMLS CUI-1
- C0438154
Beschrijving
Hematology
Alias
- UMLS CUI-1
- C0474523
Beschrijving
If No, or if results are not available, please complete details on the comments page or the protocol deviations page.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0200345
Beschrijving
Date and time of sample
Datatype
datetime
Alias
- UMLS CUI [1]
- C1302413
- UMLS CUI [2,1]
- C0040223
- UMLS CUI [2,2]
- C0200345
Beschrijving
(if different from main hospital laboratory)
Datatype
text
Alias
- UMLS CUI [1]
- C3258037
Beschrijving
Hematology
Alias
- UMLS CUI-1
- C0474523
Beschrijving
Parameter
Datatype
integer
Alias
- UMLS CUI [1]
- C0549193
Beschrijving
Result
Datatype
text
Alias
- UMLS CUI [1]
- C1274040
Beschrijving
Units
Datatype
text
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Check one box only. If any result is clinically significant, please record a diagnosis on the adverse event page.
Datatype
integer
Alias
- UMLS CUI [1]
- C0243095
Beschrijving
Not Done
Datatype
integer
Alias
- UMLS CUI [1]
- C1272696
Beschrijving
Clinical Chemistry, Coagulation and Electrolytes
Alias
- UMLS CUI-1
- C0008000
- UMLS CUI-2
- C0005778
- UMLS CUI-3
- C0013832
Beschrijving
If No, or if results are not available, please complete details on the comments page or the protocol deviations page.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0200345
Beschrijving
Date and time of sample
Datatype
datetime
Alias
- UMLS CUI [1]
- C1302413
- UMLS CUI [2,1]
- C0040223
- UMLS CUI [2,2]
- C0200345
Beschrijving
(if different from main hospital laboratory)
Datatype
text
Alias
- UMLS CUI [1]
- C3258037
Beschrijving
Clinical Chemistry, Coagulation and Electrolytes
Alias
- UMLS CUI-1
- C0008000
- UMLS CUI-2
- C0005778
- UMLS CUI-3
- C0013832
Beschrijving
Parameter
Datatype
integer
Alias
- UMLS CUI [1]
- C0549193
Beschrijving
Results
Datatype
text
Alias
- UMLS CUI [1]
- C1254595
Beschrijving
Units
Datatype
text
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Check one box only. If any result is clinically significant, please record a diagnosis on the adverse event page.
Datatype
integer
Alias
- UMLS CUI [1]
- C0243095
Beschrijving
Not Done
Datatype
integer
Alias
- UMLS CUI [1]
- C1272696
Beschrijving
Urinalysis dipstick results
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C0430370
- UMLS CUI-3
- C1274040
Beschrijving
If No, or if results are not available, please complete details on the comments page or the protocol deviations page.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0200345
Beschrijving
Date of sample
Datatype
date
Alias
- UMLS CUI [1]
- C1302413
Beschrijving
Time of sample
Datatype
time
Alias
- UMLS CUI [1]
- C4064021
Beschrijving
(if different from main hospital laboratory)
Datatype
text
Alias
- UMLS CUI [1]
- C3258037
Beschrijving
pH
Datatype
integer
Alias
- UMLS CUI [1]
- C0042044
Beschrijving
If other pH, please specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0042044
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschrijving
Glucose
Datatype
integer
Alias
- UMLS CUI [1]
- C0004076
Beschrijving
If other Glucose, please specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0004076
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschrijving
Blood
Datatype
integer
Alias
- UMLS CUI [1]
- C0018965
Beschrijving
If other Blood, please specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0018965
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschrijving
Protein
Datatype
integer
Alias
- UMLS CUI [1]
- C0262923
Beschrijving
If other Protein, please specify.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262923
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschrijving
Leucocytes
Datatype
integer
Alias
- UMLS CUI [1]
- C1256582
Beschrijving
If other Leucocytes, please specify.
Datatype
text
Alias
- UMLS CUI [1,1]
- C1256582
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschrijving
Urinalysis microscopy results
Alias
- UMLS CUI-1
- C0430397
- UMLS CUI-2
- C1274040
Beschrijving
Check one box only. If No, or if results are not available, please complete details on the comments page or the protocol deviations page.
Datatype
integer
Alias
- UMLS CUI [1]
- C0200345
Beschrijving
Date of sample
Datatype
date
Alias
- UMLS CUI [1]
- C1302413
Beschrijving
Time of sample
Datatype
time
Alias
- UMLS CUI [1]
- C4064021
Beschrijving
If different from main hospital laboratory
Datatype
text
Alias
- UMLS CUI [1]
- C3258037
Beschrijving
Urinalysis microscopy results
Alias
- UMLS CUI-1
- C0430397
- UMLS CUI-2
- C1274040
Beschrijving
Parameter
Datatype
integer
Alias
- UMLS CUI [1]
- C0549193
Beschrijving
Result
Datatype
text
Alias
- UMLS CUI [1]
- C1274040
Beschrijving
Units
Datatype
text
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Not Done
Datatype
integer
Alias
- UMLS CUI [1]
- C1272696
Beschrijving
Clinically significant?
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826293
Beschrijving
Serum beta-hCG Pregnancy Test
Alias
- UMLS CUI-1
- C0430060
Beschrijving
If Yes, complete below
Datatype
boolean
Alias
- UMLS CUI [1]
- C1960468
Beschrijving
If a serum β-hCG pregnancy test has been performed please give details.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0430060
Beschrijving
Date of pregnancy test
Datatype
date
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C0011008
Beschrijving
Check one box only
Datatype
integer
Alias
- UMLS CUI [1]
- C0427777
Beschrijving
PK Sampling - Plasma Samples
Alias
- UMLS CUI-1
- C0031327
- UMLS CUI-2
- C1277698
- UMLS CUI-3
- C1609077
Beschrijving
Check if Not Applicable
Datatype
integer
Alias
- UMLS CUI [1]
- C1272460
Beschrijving
Date of Sampling
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0870078
Beschrijving
Time of Sampling
Datatype
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0870078
Beschrijving
Check if Not Done
Datatype
integer
Alias
- UMLS CUI [1]
- C1272696
Beschrijving
Study Treatment Compliance (Return)
Alias
- UMLS CUI-1
- C1321605
Beschrijving
If No, please complete the comments page or the protocol deviations page.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C3890583
- UMLS CUI [1,2]
- C0332156
Beschrijving
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.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1321605
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C0178602
Beschrijving
No. of missed dates:
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1705492
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0237753
Beschrijving
Dates dose missed:
Datatype
text
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1705492
- UMLS CUI [1,3]
- C0178602
Beschrijving
New Adverse Events and Concomitant Treatment
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C2347852
Beschrijving
If Yes, please record details on Adverse Events page.
Datatype
boolean
Alias
- UMLS CUI [1]
- C2347852
Beschrijving
If Yes, please record details on Concomitant Treatment page.
Datatype
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])