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])
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
Code List
Intensity of Adverse Event
CL Item
Life threatening or Disabling (4)
Item
Frequency of Adverse Event
integer
C0877248 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Code List
Frequency of Adverse Event
Item
Relationship to SRT501
integer
C0304229 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
Code List
Relationship to SRT501
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])
Code List
Action Taken with SRT501
CL Item
Drug Withdrawn (1)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Not Applicable (98)
Item
Other Action taken
integer
C2826626 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Code List
Other Action taken
CL Item
Concomitant Medication (2)
Item
Action Taken with bortezomib
integer
C2826626 (UMLS CUI [1,1])
C1176309 (UMLS CUI [1,2])
Code List
Action Taken with bortezomib
CL Item
Drug Withdrawn (1)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Not Applicable (98)
Item
Outcome
integer
C1705586 (UMLS CUI [1])
CL Item
Resolved without sequalae (1)
CL Item
Resolved with sequalae (2)
CL Item
Not yet resolved (3)
SAE?
Item
SAE?
boolean
C1519255 (UMLS CUI [1])
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])
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])
CL Item
APPLICATION (APP)
CL Item
CUBIC CENTIMETRES (CC)
CL Item
DEGREES CENTIGRADE (C)
CL Item
DEGREES FAHRENHEIT (F)
CL Item
INTERNATIONAL UNITS (IU)
CL Item
MILLIEQUIVALENTS (ME)
CL Item
MILLIMOLES (MMOL)
CL Item
MICROGRAMS/KILOGRAM (MCG/KG)
CL Item
SUPPOSITORIES (SUP)
CL Item
TABLESPOONS (TBSP)
Item
Route
text
C0013153 (UMLS CUI [1])
CL Item
DUODENAL TUBE (DUT)
CL Item
INTRA-ARTERIAL (IAR)
CL Item
INTRA-ARTICULAR INJECTION (IA)
CL Item
INTRALESIONAL (IL)
CL Item
INTRAMUSCULAR (IM)
CL Item
INTRAVENOUS DIRECT (IVD)
CL Item
INTRAVENOUS INDWELLING (IVI)
CL Item
INTRAVENOUS PUSH (IVP)
CL Item
NASOGASTRIC (NGA)
CL Item
SUBCUTANEOUS (SC)
Item
Frequency
text
C3476109 (UMLS CUI [1])
CL Item
CONTINUOUS (CONT)
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
ONCE/SINGLE DOSE (X1)
CL Item
ONCE PER DAY (QD)
CL Item
ONCE PER WEEK (QWK)
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)
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])
Are any comments required?
Item
Are any comments required?
boolean
C0947611 (UMLS CUI [1,1])
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])
Comment
Item
Comment
text
C0947611 (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])
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)
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])