Date of visit/ assessment
Item
Date of visit/ assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Pharmaceutical Preparations Concomitant Therapy; Concomitant Medications; Study; During
Item
Were any concomitant medications taken by the subject during the study?
boolean
C0013227 (UMLS CUI [1,1])
C1707479 (UMLS CUI [1,2])
C2603343 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,4])
Non-serious Adverse Event; Study; During
Item
Did the subject experience any non- serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1,1])
C2603343 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
Serious Adverse Event; Study; During
Item
Did the subject experience any serious adverse events during the study?
boolean
C1519255 (UMLS CUI [1,1])
C2603343 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
Hematologic Tests; Blood sample taken; Repeat | Chemistry, Clinical; Specimen Collection; Repeat
Item
Were any repeat hematology or clinical chemistry samples taken?
boolean
C0018941 (UMLS CUI [1,1])
C1277698 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
C0008000 (UMLS CUI [2,1])
C0200345 (UMLS CUI [2,2])
C0205341 (UMLS CUI [2,3])
Urinalysis; Specimen Collection; Repeat
Item
Were any repeat urinalysis samples taken?
boolean
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
Electrocardiogram; Repeat
Item
Were any repeat ECGs performed?
boolean
C0013798 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
ECG abnormality; Clinically Significant Indicator
Item
Were any clinically significant ECG abnormaliites?
boolean
C1832603 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Vital signs; Repeat
Item
Were any repeat vital signs recorded?
boolean
C0518766 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Blood sample taken; Drug Kinetics; Repeat
Item
Were any repeat PK blood samples taken?
boolean
C1277698 (UMLS CUI [1,1])
C0031327 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
Holter Electrocardiography; Repeat
Item
Was any repeat Holter monitoring performed?
boolean
C0013801 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Holter Electrocardiography; Electrocardiogram abnormal; Clinically Significant Indicator
Item
Were any clinically significant Holter abnormalities?
boolean
C0013801 (UMLS CUI [1,1])
C0522055 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,3])
Pharmaceutical Preparations; Concomitant Therapy; Sequence Number
Item
Medication Sequence Number
integer
C0013227 (UMLS CUI [1,1])
C1707479 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,3])
Medication name
Item
Drug Name (Trade Name preferred)
text
C2360065 (UMLS CUI [1])
Concomitant Medication Dose Unit
Item
Concomitant Medication Unit Dose
float
C2826646 (UMLS CUI [1])
Item
Units
integer
C0439148 (UMLS CUI [1])
CL Item
Area under curve (4)
CL Item
Cubic centimeter (7)
CL Item
Gamma per kilogram per minute (9)
CL Item
100 International units/ml (12)
CL Item
International units (14)
CL Item
International units per kilogram (15)
CL Item
International units per kilogram per hour (16)
CL Item
International units per mililitre (17)
CL Item
Litre per minute (20)
CL Item
Minimum alveolar concentration (21)
CL Item
Mega becquerels (Mbq) (22)
CL Item
Microgram (MCG) (23)
CL Item
Micrograms per hour (24)
CL Item
Microgram/ kilogram (25)
CL Item
Microgram/ kilogram per minute (26)
CL Item
Micrograms per minute (27)
CL Item
Micrograms per mililitre (28)
CL Item
Milliequivalent (30)
CL Item
Milliequivalent per 24 hours (31)
CL Item
Miligram per day (33)
CL Item
Miligram per hour (34)
CL Item
Miligram/ kilogram (35)
CL Item
Miligram/ kilogram per hour (36)
CL Item
Miligram/ kilogram per minute (37)
CL Item
Miligram/ metre squared (38)
CL Item
Miligram/ mililitre (39)
CL Item
Miligrams percent (40)
CL Item
Million international units (41)
CL Item
Mililitre per hour (43)
CL Item
Mililitre per minute (44)
CL Item
Megaunits (million units) (46)
CL Item
Microgram (UG) (58)
CL Item
Units per hour (59)
CL Item
Units per kilogram pe rminute (60)
CL Item
Units per minute (61)
Item
Mediacation Frequency
integer
C3476109 (UMLS CUI [1])
Code List
Mediacation Frequency
CL Item
2 times per week (1)
CL Item
3 times per week (2)
CL Item
4 times per week (3)
CL Item
5 times per day (4)
CL Item
5 times per week (5)
CL Item
Continious infusion (8)
CL Item
Every 2 Weeks (16)
CL Item
Every 3 month (18)
CL Item
Every 3 weeks (19)
CL Item
Once a month (27)
CL Item
Every other day (28)
Item
Medication Route
integer
C0013153 (UMLS CUI [1])
Code List
Medication Route
CL Item
Gastrostomy tube (2)
CL Item
Intra- arterial (3)
CL Item
Intra- articular (4)
CL Item
Intralesional (8)
CL Item
Intramuscular (9)
CL Item
Intraperitoneal (14)
CL Item
Intrauterine (16)
CL Item
Subcutaneous (28)
Concomitant Medication Use Indication
Item
Reason for Medication
text
C2826696 (UMLS CUI [1])
Concomitant Medication Start Date | Pharmaceutical Preparations; Concomitant Therapy; Start time
Item
Start Date and Time
datetime
C2826734 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C1707479 (UMLS CUI [2,2])
C1301880 (UMLS CUI [2,3])
Pharmaceutical Preparations; Concomitant Therapy; Study; Before
Item
Concomitant medication taken prior to study?
boolean
C0013227 (UMLS CUI [1,1])
C1707479 (UMLS CUI [1,2])
C2603343 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
Concomitant Medication Ongoing
Item
Concomitant Medication Ongoing?
boolean
C2826666 (UMLS CUI [1])
Concomitant Medication End Date | Pharmaceutical Preparations; Concomitant Therapy; End Time
Item
If concomitant medication not ongoing, specify End Date and Time.
datetime
C2826744 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C1707479 (UMLS CUI [2,2])
C1522314 (UMLS CUI [2,3])