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Falhas:
ID
35385
Descrição
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
Palavras-chave
Versões (4)
- 04/03/2019 04/03/2019 -
- 10/03/2019 10/03/2019 -
- 10/03/2019 10/03/2019 -
- 30/10/2019 30/10/2019 - Sarah Riepenhausen
Titular dos direitos
GlaxoSmithKline
Transferido a
4 de março de 2019
DOI
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Licença
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
Non Visit - Adverse Events; Prior and Concomitant Medications; Comments; Protocol Deviations; Data Verification
Similar models
Non Visit - Adverse Events; Prior and Concomitant Medications; Comments; Protocol Deviations; Data Verification
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Subject Number
Item
Subject Number
integer
C2348585 (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])
C0205314 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
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])
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])
C0439603 (UMLS CUI [1,2])
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])
C0439849 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
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])
C0439849 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
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])
C0205394 (UMLS CUI [1,2])
CL Item
None (1)
CL Item
Concomitant Medication (2)
CL Item
Other (99)
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)
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])
C2347852 (UMLS CUI [1,2])
Item Group
Prior and Concomitant Medications
C2826257 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
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])
C1504335 (UMLS CUI [1,2])
Start date
Item
Start date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
End date
Item
End date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
Dose
Item
Dose
integer
C3174092 (UMLS CUI [1])
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)
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)
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])
C0877248 (UMLS CUI [1,2])
C2348184 (UMLS CUI [2])
Item Group
Are any comments required?
C0947611 (UMLS CUI-1)
C1514873 (UMLS CUI-2)
C1514873 (UMLS CUI-2)
Are any comments required?
Item
Are any comments required?
boolean
C0947611 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,2])
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])
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])
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])
C1516308 (UMLS CUI [1,2])
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, (9)
CL Item
grapes, mulberries and alcohol within 48 hours prior to PK sample collections. (Only applicable (10)
CL Item
for PK subjects). (11)
CL Item
Other (please specify) (10)
Investigator statement
Item
Investigator's Signuature
text
C4086865 (UMLS CUI [1])
C2346576 (UMLS CUI [2])
C2346576 (UMLS CUI [2])
Signature Date
Item
Signature Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
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