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35573

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

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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
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GlaxoSmithKline

Hochgeladen am

10. März 2019

DOI

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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
    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
    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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