Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Centre Number
Item
Centre Number
integer
C0019994 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Randomisation Number
Item
Randomisation Number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
serious adverse event
Item
Did the subject experience a serious adverse event during the study?
boolean
C1519255 (UMLS CUI [1])
Serious Adverse Event
Item
Serious Adverse Event Diagnosis Only (if known) Otherwise Sign/Symptom
text
C1519255 (UMLS CUI [1])
Serious Adverse Event Start Date
Item
Serious Adverse Event Start Date
date
C1519255 (UMLS CUI [1,1])
C2697888 (UMLS CUI [1,2])
Start Time Serious Adverse Event
Item
Start Time Serious Adverse Event
time
C1519255 (UMLS CUI [1,1])
C2697889 (UMLS CUI [1,2])
Serious Adverse Event End Date
Item
Serious Adverse Event End Date
date
C1519255 (UMLS CUI [1,1])
C2697886 (UMLS CUI [1,2])
Serious Adverse Event End Time
Item
Serious Adverse Event End Time
time
C1519255 (UMLS CUI [1,1])
C2826658 (UMLS CUI [1,2])
Item
Outcome
integer
C1624730 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae (4)
CL Item
Fatal, record Date of Death (5)
Date of Death
Item
Date of Death
date
C1148348 (UMLS CUI [1])
autopsy
Item
If fatal, was a post-mortem/autopsy performed
boolean
C0004398 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Maximum Intensity
integer
C0518690 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Code List
Maximum Intensity
CL Item
Not applicable (4)
Item
Action Taken with Respect to Investigational Drug
integer
C1547656 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Code List
Action Taken with Respect to Investigational Drug
CL Item
lnvestigational product(s) withdrawn (1)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (6)
Relationship investigational product
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Did the subject withdraw from study as a result of this AE?
Item
Did the subject withdraw from study as a result of this AE?
boolean
C1710677 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Seriousness, Specify the reason for considering this an SAE
integer
C1710056 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Code List
Seriousness, Specify the reason for considering this an SAE
CL Item
Results in death (1)
CL Item
Is life-threatening (2)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (3)
CL Item
Results in disability/incapacity (4)
CL Item
Congenital anomaly/birth defect (5)
CL Item
Other, specify within general narrative comment (6)
Item
Possible Cause of SAE Other Than Investigational Product(s):
integer
C3641099 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Code List
Possible Cause of SAE Other Than Investigational Product(s):
CL Item
Disease under study (1)
CL Item
Medical condition(s) (2)
CL Item
Lack of efficacy (3)
CL Item
Withdrawal of investigational product(s) (4)
CL Item
Concomitant medication (5)
CL Item
Activity related to study participation (6)
CL Item
Other, specify (7)
SAE Causation
Item
If other ossible Cause of SAE, specify
text
C3641099 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
adverse event recur
Item
If deliberate or inadvertent administration of further dose(s) of investigational product(s) to the subject occurred, did the reported adverse event recur?
boolean
C0304229 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0034897 (UMLS CUI [1,3])
Serious Adverse Event Recurrence
Item
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
boolean
C1519255 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Details of relevant Assessments
Item
Details of RELEVANT Assessments (provide details of any other tests/procedures which were carried out to diagnose or confirm the SAE e.g., laboratory data with units and normal range)
text
C0430022 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
General narrative comments
Item
General narrative comments
text
C1519255 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Investigator’s signature
Item
Investigator’s signature
text
C2346576 (UMLS CUI [1])
Specific Condition name
Item
Specific Condition name
text
C0012634 (UMLS CUI [1])
Date of onset
Item
Date of onset
date
C0012634 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Condition Present at Time of the SAE
Item
Condition Present at Time of the SAE?
boolean
C0012634 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
date of last occurrence
Item
No, specify date of last occurrence
date
C2745955 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Drug name
Item
Drug name
text
C2360065 (UMLS CUI [1])
Total Daily Dose
Item
Total Daily Dose
float
C2348070 (UMLS CUI [1])
Item
Unit
integer
C0013227 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
CL Item
Actuation ACTU (1)
CL Item
Application AP (3)
CL Item
Cubic centimeter cc (6)
CL Item
International units (9)
CL Item
International units per kilogram (10)
CL Item
Internatcional units per millilitre IUML (11)
CL Item
Litre per minute LM (13)
CL Item
Megaunits (million units) MEGU (15)
CL Item
Microgram (MCG) (16)
CL Item
Microgram (UG) (17)
CL Item
Microgram /kilogram (18)
CL Item
Microgram/kilogram per minute MCG/KG/MIN (19)
CL Item
Micrograms per minute MCG/MIN (20)
CL Item
Milliequivalent (22)
CL Item
Milliequivalent per 24 hours MEQ24 (23)
CL Item
Milligrams percent MGPER (25)
CL Item
Milligram per hour MGH (26)
CL Item
Milligram/kilogram (27)
CL Item
Milligram/kilogram per hour MGKH (28)
CL Item
Milligram/kilogram per minute MGKM (29)
CL Item
Milligram/metre squared (30)
CL Item
Milligram/millilitre MGML (31)
CL Item
Millilitre per hour MLH (33)
CL Item
Millilitre per minute MLM (34)
CL Item
Million international units (36)
CL Item
Minimum alveolar concentration MAC (37)
CL Item
Suppository SUP (44)
CL Item
Tablespoon TBS (45)
CL Item
Teaspoon TSP (47)
Item
Frequency
integer
C3476109 (UMLS CUI [1])
CL Item
2 times per week 2W (1)
CL Item
3 times per week 3W (2)
CL Item
4times per week 4W (3)
CL Item
5 times per day 50 (4)
CL Item
5 times per week SW (5)
CL Item
Continuous Infusion co (8)
CL Item
Every 2 weeks FO (9)
CL Item
Every 3 weeks Q3WK (10)
CL Item
Every 3 months Q3M (11)
CL Item
Every other day AD (12)
CL Item
At Bedtime IN (13)
CL Item
Once a month MO (14)
CL Item
Once a week WE (15)
CL Item
Once daily 1D (16)
CL Item
Once only 15 (17)
Item
Route
integer
C0013153 (UMLS CUI [1])
CL Item
Both eyes 047 (1)
CL Item
Gastrostomy tube GT (3)
CL Item
Inhalation 055 (4)
CL Item
Injection INJ (5)
CL Item
Intra-arterial 013 (6)
CL Item
Intra-buru IBU (7)
CL Item
Intralesional 026 (8)
CL Item
IM Intramuscular 030 (9)
CL Item
Intranasal 045 (10)
CL Item
Intraocular 031 (11)
CL Item
Intraosteal 10S (12)
CL Item
Intraperitoneal 033 (13)
CL Item
lntrathecal 037 (14)
CL Item
Intrauterine 015 (15)
CL Item
IV Intravenous 042 (16)
CL Item
Subcutaneous 058 (20)
CL Item
Sublingua1 060 (21)
CL Item
Transdermal 062 (23)
Taken Prior to Study?
Item
Taken Prior to Study?
boolean
C2826667 (UMLS CUI [1])
start date of medication
Item
Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
End Date of medication
Item
End Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Medication Ongoing
Item
Medication Ongoing?
boolean
C2826666 (UMLS CUI [1])
Reason for Medication
Item
Reason for Medication
text
C2347852 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Investigational Product Period and Formulation
Item
Investigational Product Period and Formulation
text
C0304229 (UMLS CUI [1])
Date of Dose
Item
Date of Dose
date
C0304229 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of Dose
Item
Time of Dose
time
C0304229 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])