ID

35574

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 (4)
  1. 04.03.19 04.03.19 -
  2. 10.03.19 10.03.19 -
  3. 10.03.19 10.03.19 -
  4. 30.10.19 30.10.19 - Sarah Riepenhausen
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

10. März 2019

DOI

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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

Englisch

Non Visit - Adverse Events; Prior and Concomitant Medications; Comments; Protocol Deviations; Data Verification

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Subject Number
Beschreibung

Subject Number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Adverse Events
Beschreibung

Adverse Events

Alias
UMLS CUI-1
C0877248
Has the Subject experienced any new Adverse Events occurring after signing the Informed Consent?
Beschreibung

If Yes, please record details below

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0205314
UMLS CUI [2]
C0021430
Adverse Events
Beschreibung

Adverse Events

Alias
UMLS CUI-1
C0877248
Seq #
Beschreibung

Seq #

Datentyp

integer

Alias
UMLS CUI [1]
C0237753
Adverse Event
Beschreibung

Please enter one event per line.

Datentyp

text

Alias
UMLS CUI [1]
C0877248
Start date and time of Adverse Event
Beschreibung

Start date and time of Adverse Event

Datentyp

datetime

Alias
UMLS CUI [1]
C2826806
End date and time of Adverse Event
Beschreibung

End date and time of Adverse Event

Datentyp

datetime

Alias
UMLS CUI [1]
C2826793
Intensity of Adverse Event
Beschreibung

Enter only one.

Datentyp

integer

Frequency of Adverse Event
Beschreibung

Frequency of Adverse Event

Datentyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0439603
Relationship to SRT501
Beschreibung

Enter only one

Datentyp

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0877248
Relationship to bortezomib
Beschreibung

Relationship to bortezomib

Datentyp

text

Alias
UMLS CUI [1,1]
C1176309
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0877248
Action Taken with SRT501
Beschreibung

Enter only one.

Datentyp

integer

Alias
UMLS CUI [1]
C2826626
Other Action taken
Beschreibung

If Other, please specify.

Datentyp

integer

Alias
UMLS CUI [1,1]
C2826626
UMLS CUI [1,2]
C0205394
Action Taken with bortezomib
Beschreibung

Enter only one.

Datentyp

integer

Alias
UMLS CUI [1,1]
C2826626
UMLS CUI [1,2]
C1176309
Outcome
Beschreibung

Enter only one.

Datentyp

integer

Alias
UMLS CUI [1]
C1705586
SAE?
Beschreibung

SAE?

Datentyp

boolean

Alias
UMLS CUI [1]
C1519255
Prior and Concomitant Medications
Beschreibung

Prior and Concomitant Medications

Alias
UMLS CUI-1
C2826257
UMLS CUI-2
C2347852
Has the Subject had any treatment (medication, device or therapy) within 28 days prior to first dose of SRT501 or during the study period?
Beschreibung

If Yes, please record details below.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2826257
UMLS CUI [1,2]
C2347852
Prior and Concomitant Medications
Beschreibung

Prior and Concomitant Medications

Alias
UMLS CUI-1
C2826257
UMLS CUI-2
C2347852
Seq #
Beschreibung

Seq #

Datentyp

integer

Alias
UMLS CUI [1]
C0237753
Medication, device or therapy
Beschreibung

e.g. PARACETAMOL

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1504335
Start date
Beschreibung

Start date

Datentyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
End date
Beschreibung

End date

Datentyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Dose
Beschreibung

e.g. 500

Datentyp

integer

Alias
UMLS CUI [1]
C3174092
Unit
Beschreibung

e.g. mg

Datentyp

text

Alias
UMLS CUI [1]
C1519795
Route
Beschreibung

e.g. PO

Datentyp

text

Alias
UMLS CUI [1]
C0013153
Frequency
Beschreibung

e.g. BD

Datentyp

text

Alias
UMLS CUI [1]
C3476109
Indication
Beschreibung

e.g. headache

Datentyp

text

Alias
UMLS CUI [1]
C3146298
If indication is an adverse event, please record sequence number(s) from the AE page
Beschreibung

e.g. 02

Datentyp

integer

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0877248
UMLS CUI [2]
C2348184
Are any comments required?
Beschreibung

Are any comments required?

Alias
UMLS CUI-1
C0947611
UMLS CUI-2
C1514873
Are any comments required?
Beschreibung

If Yes, please record details below

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1514873
Comments
Beschreibung

Comments

Alias
UMLS CUI-1
C0947611
Seq #
Beschreibung

Seq #

Datentyp

integer

Alias
UMLS CUI [1]
C0237753
CRF Page referenced
Beschreibung

CRF Page referenced

Datentyp

text

Alias
UMLS CUI [1,1]
C1704732
UMLS CUI [1,2]
C1516308
Comment
Beschreibung

Comment

Datentyp

text

Alias
UMLS CUI [1]
C0947611
Did the subject deviate from the procedures as described in the protocol?
Beschreibung

Did the subject deviate from the procedures as described in the protocol?

Alias
UMLS CUI-1
C1705236
Did the subject deviate from the procedures as described in the protocol?
Beschreibung

If Yes, please record details below

Datentyp

boolean

Alias
UMLS CUI [1]
C1705236
Protocol Deviations
Beschreibung

Protocol Deviations

Alias
UMLS CUI-1
C1705236
Seq #
Beschreibung

Seq #

Datentyp

integer

Alias
UMLS CUI [1]
C0237753
CRF Page referenced
Beschreibung

CRF Page referenced

Datentyp

text

Alias
UMLS CUI [1,1]
C1704732
UMLS CUI [1,2]
C1516308
Code
Beschreibung

Code

Datentyp

integer

Data Verification
Beschreibung

Data Verification

Alias
UMLS CUI-1
C4086865
Investigator's Signuature
Beschreibung

Investigator statement - I confirm that to the best of my knowledge, the observations and data are recorded completely and accurately within this CRF.

Datentyp

text

Alias
UMLS CUI [1]
C4086865
UMLS CUI [2]
C2346576
Signature Date
Beschreibung

Signature Date

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Ähnliche Modelle

Non Visit - Adverse Events; Prior and Concomitant Medications; Comments; Protocol Deviations; Data Verification

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Adverse Events
C0877248 (UMLS CUI-1)
Has the Subject experienced any new Adverse Events occurring after signing the Informed Consent?
Item
Has the Subject experienced any new Adverse Events occurring after signing the Informed Consent?
boolean
C0877248 (UMLS CUI [1,1])
C0205314 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Item Group
Adverse Events
C0877248 (UMLS CUI-1)
Seq #
Item
Seq #
integer
C0237753 (UMLS CUI [1])
Adverse Event
Item
Adverse Event
text
C0877248 (UMLS CUI [1])
Start date and time of Adverse Event
Item
Start date and time of Adverse Event
datetime
C2826806 (UMLS CUI [1])
End date and time of Adverse Event
Item
End date and time of Adverse Event
datetime
C2826793 (UMLS CUI [1])
Item
Intensity of Adverse Event
integer
Intensity of Adverse Event
Code List
Intensity of Adverse Event
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe  (3)
CL Item
Life threatening or Disabling (4)
CL Item
Death (5)
Item
Frequency of Adverse Event
integer
C0877248 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Frequency of Adverse Event
Code List
Frequency of Adverse Event
CL Item
Intermittent  (1)
CL Item
Continuous (2)
Item
Relationship to SRT501
integer
C0304229 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
Relationship to SRT501
Code List
Relationship to SRT501
CL Item
Not related  (0)
CL Item
Unlikely related  (1)
CL Item
Possibly related  (2)
CL Item
Probably related  (3)
CL Item
Definitely related (4)
Relationship to bortezomib
Item
Relationship to bortezomib
text
C1176309 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
Item
Action Taken with SRT501
integer
C2826626 (UMLS CUI [1])
Action Taken with SRT501
Code List
Action Taken with SRT501
CL Item
None  (0)
CL Item
Drug Withdrawn  (1)
CL Item
Dose reduced  (2)
CL Item
Dose increased  (3)
CL Item
Dose not changed (4)
CL Item
Unknown  (97)
CL Item
Not Applicable (98)
Item
Other Action taken
integer
C2826626 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Other Action taken
Code List
Other Action taken
CL Item
None  (1)
CL Item
Concomitant Medication  (2)
CL Item
Other (99)
Item
Action Taken with bortezomib
integer
C2826626 (UMLS CUI [1,1])
C1176309 (UMLS CUI [1,2])
Action Taken with bortezomib
Code List
Action Taken with bortezomib
CL Item
None  (0)
CL Item
Drug Withdrawn  (1)
CL Item
Dose reduced  (2)
CL Item
Dose increased  (3)
CL Item
Dose not changed  (4)
CL Item
Unknown  (97)
CL Item
Not Applicable (98)
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome
CL Item
Resolved without sequalae (1)
CL Item
Resolved with sequalae  (2)
CL Item
Not yet resolved  (3)
CL Item
Death  (4)
CL Item
Unknown (97)
SAE?
Item
SAE?
boolean
C1519255 (UMLS CUI [1])
Item Group
Prior and Concomitant Medications
C2826257 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Has the Subject had any treatment (medication, device or therapy) within 28 days prior to first dose of SRT501 or during the study period?
Item
Has the Subject had any treatment (medication, device or therapy) within 28 days prior to first dose of SRT501 or during the study period?
boolean
C2826257 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Item Group
Prior and Concomitant Medications
C2826257 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Seq #
Item
Seq #
integer
C0237753 (UMLS CUI [1])
Medication, device or therapy
Item
Medication, device or therapy
text
C0013227 (UMLS CUI [1,1])
C1504335 (UMLS CUI [1,2])
Start date
Item
Start date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
End date
Item
End date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Dose
Item
Dose
integer
C3174092 (UMLS CUI [1])
Item
Unit
text
C1519795 (UMLS CUI [1])
Unit
Code List
Unit
CL Item
AMPOULES  (AMP)
CL Item
APPLICATION  (APP)
CL Item
CAPSULES  (CAP)
CL Item
CENTIMETRES  (CM)
CL Item
CUBIC CENTIMETRES  (CC)
CL Item
DEGREES CENTIGRADE  (C)
CL Item
DEGREES FAHRENHEIT  (F)
CL Item
DROP(S)  (GT)
CL Item
GRAIN(S)  (GRN)
CL Item
GRAMS  (G)
CL Item
INCHES  (IN)
CL Item
INHALATION  (INH)
CL Item
INTERNATIONAL UNITS  (IU)
CL Item
KILOGRAMS  (KG)
CL Item
LITRES  (L)
CL Item
LOZENGES  (LOZ)
CL Item
METRES  (M)
CL Item
MILLIEQUIVALENTS  (ME)
CL Item
MILLIGRAMS  (MG)
CL Item
MILLILITRES  (ML)
CL Item
MILLIMETRES  (MM)
CL Item
MILLIMOLES  (MMOL)
CL Item
MICROGRAMS  (MCG)
CL Item
MICROGRAMS/KILOGRAM  (MCG/KG)
CL Item
MICROLITRES  (UL)
CL Item
NANOGRAMS  (NG)
CL Item
NOT KNOWN  (NK)
CL Item
OTHER  (OTH)
CL Item
PERCENTAGE  (%)
CL Item
PESSARIES  (PES)
CL Item
POUNDS  (LB)
CL Item
PUFFS  (PFF)
CL Item
SACHETS  (SAC)
CL Item
SPRAY  (SPR)
CL Item
SUPPOSITORIES  (SUP)
CL Item
TABLESPOONS  (TBSP)
CL Item
TABLETS  (TAB)
CL Item
TEASPOONS  (TSP)
CL Item
VIALS (VI)
Item
Route
text
C0013153 (UMLS CUI [1])
Route
Code List
Route
CL Item
AURAL  (AU)
CL Item
DUODENAL TUBE  (DUT)
CL Item
EPIDURAL  (EPD)
CL Item
INHALED  (IH)
CL Item
INTRA-ARTERIAL  (IAR)
CL Item
INTRA-ARTICULAR INJECTION  (IA)
CL Item
INTRADERMAL  (ID)
CL Item
INTRALESIONAL  (IL)
CL Item
INTRAMUSCULAR  (IM)
CL Item
INTRATHECAL  (IT)
CL Item
INTRAVENOUS  (IV)
CL Item
INTRAVENOUS DIRECT  (IVD)
CL Item
INTRAVENOUS INDWELLING  (IVI)
CL Item
INTRAVENOUS PUSH  (IVP)
CL Item
NASAL  (NA)
CL Item
NASOGASTRIC  (NGA)
CL Item
NOT KNOWN  (NK)
CL Item
OPHTHALMIC  (OPT)
CL Item
ORAL  (PO)
CL Item
OTHER  (OTH)
CL Item
RECTAL  (PR)
CL Item
SUBCUTANEOUS  (SC)
CL Item
SUBLINGUAL  (SL)
CL Item
TRANSDERMAL  (TD)
CL Item
TOPICAL  (TOP)
CL Item
VAGINAL (VA)
Item
Frequency
text
C3476109 (UMLS CUI [1])
Frequency
Code List
Frequency
CL Item
AS NEEDED  (PRN)
CL Item
CONTINUOUS  (CONT)
CL Item
EVERY HOUR  (Q1H)
CL Item
EVERY NIGHT/NOCTE  (ON)
CL Item
EVERY OTHER DAY  (QOD)
CL Item
EVERY 2 HOURS  (Q2H)
CL Item
EVERY 3 HOURS  (Q3H)
CL Item
EVERY 4 HOURS  (Q4H)
CL Item
EVERY 6 HOURS  (Q6H)
CL Item
EVERY 8 HOURS  (Q8H)
CL Item
EVERY 12 HOURS  (Q12H)
CL Item
EVERY OTHER WEEK  (Q14D)
CL Item
EVERY 28 DAYS  (Q28D)
CL Item
IN THE MORNING/MANE  (OM)
CL Item
MONTHLY  (MON)
CL Item
NOT KNOWN  (NK)
CL Item
ONCE/SINGLE DOSE  (X1)
CL Item
ONCE PER DAY  (QD)
CL Item
ONCE PER WEEK  (QWK)
CL Item
OTHER  (OTH)
CL Item
TWICE PER WEEK  (BWK)
CL Item
TWICE PER DAY  (BD)
CL Item
THREE TIMES PER DAY  (TDS)
CL Item
FOUR TIMES PER DAY  (QDS)
CL Item
WITH MEALS (WM)
Indication
Item
Indication
text
C3146298 (UMLS CUI [1])
If indication is an adverse event, please record sequence number(s) from the AE page
Item
If indication is an adverse event, please record sequence number(s) from the AE page
integer
C3146298 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C2348184 (UMLS CUI [2])
Item Group
Are any comments required?
C0947611 (UMLS CUI-1)
C1514873 (UMLS CUI-2)
Are any comments required?
Item
Are any comments required?
boolean
C0947611 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
Item Group
Comments
C0947611 (UMLS CUI-1)
Seq #
Item
Seq #
integer
C0237753 (UMLS CUI [1])
CRF Page referenced
Item
CRF Page referenced
text
C1704732 (UMLS CUI [1,1])
C1516308 (UMLS CUI [1,2])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Did the subject deviate from the procedures as described in the protocol?
C1705236 (UMLS CUI-1)
Did the subject deviate from the procedures as described in the protocol?
Item
Did the subject deviate from the procedures as described in the protocol?
boolean
C1705236 (UMLS CUI [1])
Item Group
Protocol Deviations
C1705236 (UMLS CUI-1)
Seq #
Item
Seq #
integer
C0237753 (UMLS CUI [1])
CRF Page referenced
Item
CRF Page referenced
text
C1704732 (UMLS CUI [1,1])
C1516308 (UMLS CUI [1,2])
Item
Code
integer
Code
Code List
Code
CL Item
Unmet Inclusion Criteria/Exclusion Criteria (please specify the IC/EC number)  (1)
CL Item
Consent signed after study procedures started  (2)
CL Item
Visit not done (please specify visit)  (3)
CL Item
Visit out of window (please specify visit)  (4)
CL Item
Procedure out of allowable or permissible time label (please specify procedure)  (5)
CL Item
Dosing not performed according to the protocol  (6)
CL Item
Sampling not performed according to the protocol  (7)
CL Item
Meal not consumed according to the protocol  (8)
CL Item
Subject ingested large quantities of resveratrol containing food and drink such as peanuts, grapes, mulberries and alcohol within 48 hours prior to PK sample collections. (Only applicable for PK subjects). (9)
CL Item
Other (please specify) (10)
CL Item
Other (please specify) (10)
Item Group
Data Verification
C4086865 (UMLS CUI-1)
Investigator statement
Item
Investigator's Signuature
text
C4086865 (UMLS CUI [1])
C2346576 (UMLS CUI [2])
Signature Date
Item
Signature Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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