Non-serious adverse event; Diagnosis | Non-serious adverse event; Signs and Symptoms
Item
Non- Serious Adverse Event (Diagnosis only [if known], otherwise Sign/ Symptoms)
text
C1518404 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C0037088 (UMLS CUI [2,2])
Adverse Event Start Date Time
Item
Non- Serious Adverse Event Start Date and Time
datetime
C2826806 (UMLS CUI [1])
Item
Non- Serious Adverse Event Outcome
integer
C1705586 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Code List
Non- Serious Adverse Event Outcome
CL Item
Recovered/ Resolved (provide End Date and Time) (1)
CL Item
Recovering/ Resolving (2)
CL Item
Not recovered/ Not resolved (3)
CL Item
Recovered/ Resolved with sequelae (provide End Date and Time) (4)
Adverse Event Outcome | Adverse Event End Date Time
Item
If Non- Serious Adverse Event Outcome was Recovered/ Resolved or Recovered/ Resolved with sequelae, pleas provide End Date and Time
datetime
C1705586 (UMLS CUI [1])
C2826793 (UMLS CUI [2])
Item
Non- Serious Adverse Event Frequency
integer
C1518404 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Code List
Non- Serious Adverse Event Frequency
CL Item
Single Episode (1)
Item
Maximum Intensity of Non- Serious Adverse Event
integer
C1710066 (UMLS CUI [1])
Code List
Maximum Intensity of Non- Serious Adverse Event
CL Item
Not applicable (4)
Item
Maximum Grade of Adverse Event
integer
C1518404 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
Code List
Maximum Grade of Adverse Event
CL Item
Not applicable (6)
Item
Maximum Grade or Intensity of Non- serious Adverse Event
integer
C0877248 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C1710066 (UMLS CUI [2])
Code List
Maximum Grade or Intensity of Non- serious Adverse Event
CL Item
Mild or Grade 1 (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Severe or Grade 3 (3)
CL Item
Not applicable (6)
Item
Action taken with Investigational Product(s) as a Result of the Non- serious Adverse Event
integer
C0304229 (UMLS CUI [1,1])
C1299575 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2])
Code List
Action taken with Investigational Product(s) as a Result of the Non- serious Adverse Event
CL Item
Investigational product(s) withdrawn (1)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)
Study Withdrawn | Non- serious Adverse event
Item
Did the subject withdraw from study as a result of this Non- serious Adverse Event?
boolean
C2348571 (UMLS CUI [1])
C1518404 (UMLS CUI [2])
Experimental drug; Non-serious Adverse event; Causations
Item
Is there a reasonable possibility that the Non- serious Adverse Event may have been caused by the investigational product?
boolean
C0304229 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
Non-serious Adverse event; Duration (temporal concept)
Item
Duration of Non- serious Adverse Event if <24 hours
durationDatetime
C1518404 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Non-serious Adverse event; Time of onset; Date last dose
Item
Time to Onset of Non- serious Adverse Event Since Last Dose
time
C1518404 (UMLS CUI [1,1])
C0449244 (UMLS CUI [1,2])
C1762893 (UMLS CUI [1,3])
Item
Type of Report
integer
C0585733 (UMLS CUI [1])
CL Item
Initial report (1)
Serious Adverse Event; Experimental drug; Post
Item
Did Serious Adverse Event occur after initiation of study medication?
boolean
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
Serious Adverse Event; Diagnosis | Serious Adverse Event; Signs and Symptoms
Item
Serious Adverse Event (Diagnosis only [if known], otherwise Signs/ Symptoms)
text
C1519255 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0037088 (UMLS CUI [2,2])
Serious Adverse Event; Start Date | Serious Adverse Event; Start time
Item
Serious Adverse Event Start Date and Time
datetime
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
Item
Serious Adverse Event Outcome
integer
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Code List
Serious Adverse Event Outcome
CL Item
Recovered/ Resolved (provide End Date and Time) (1)
CL Item
Recovering/ Resolving (2)
CL Item
Not recovered/ Not resolved (3)
CL Item
Recovered/ Resolved with sequelae (provide End Date and Time) (4)
Adverse Event Outcome | Adverse Event End Date Time
Item
If Serious Adverse Event Outcome was Recovered/ Resolved or Recovered/ Resolved with sequelae, pleas provide End Date and Time
datetime
C1705586 (UMLS CUI [1])
C2826793 (UMLS CUI [2])
Item
Maximum Intensity of Serious Adverse Event
integer
C1710066 (UMLS CUI [1])
Code List
Maximum Intensity of Serious Adverse Event
CL Item
Not applicable (4)
Item
Maximum Grade of Serious Adverse Event
integer
C1519255 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
Code List
Maximum Grade of Serious Adverse Event
CL Item
Not applicable (6)
Item
Maximum Grade or Intensity of Serious Adverse Event
integer
C1519255 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C1710066 (UMLS CUI [2])
Code List
Maximum Grade or Intensity of Serious Adverse Event
CL Item
Mild or Grade 1 (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Severe or Grade 3 (3)
CL Item
Not applicable (6)
Item
Action taken with Investigational Product(s) as a Result of the Serious Adverse Event
integer
C0304229 (UMLS CUI [1,1])
C1299575 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Code List
Action taken with Investigational Product(s) as a Result of the Serious Adverse Event
CL Item
Investigational 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)
Study Withdrawn | Serious Adverse event
Item
Did the subject withdraw from study as a result of this Serious Adverse Event?
boolean
C2348571 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
Experimental drug; Serious Adverse event; Causations
Item
Is there a reasonable possibility that the Serious Adverse Event may have been caused by the investigational product?
boolean
C0304229 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
Serious Adverse event; Duration (temporal concept)
Item
Duration of Serious Adverse Event if <24 hours
durationDatetime
C0449238 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Serious Adverse event; Time of onset; Date last dose
Item
Time to Onset of Serious Adverse Event Since Last Dose
time
C1519255 (UMLS CUI [1,1])
C0449244 (UMLS CUI [1,2])
C1762893 (UMLS CUI [1,3])
Serious Adverse Event; Study Treatment Causality
Item
Was the Serious Adverse Event caused by activities related to study participation (e. g. procedures?)
boolean
C1519255 (UMLS CUI [1,1])
C3641099 (UMLS CUI [1,2])
Serious Adverse Event
Item
Was the event serious?
boolean
C1519255 (UMLS CUI [1])
Item
Specify Seriousness of Serious Adverse Event
text
C1710056 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Code List
Specify Seriousness of Serious Adverse Event
CL Item
Results in Death (A)
CL Item
Is life- threatening (B)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (C)
CL Item
Results in disability/ incapacity (D)
CL Item
Congenital anormaly/ borth defect (E)
CL Item
Other, specify within general narrative comment (F)
Medication name
Item
Drug Name (Trade Name preferred)
text
C2360065 (UMLS CUI [1])
Concomitant Therapy; Medication dose
Item
Concomitant Medication Dose
text
C1707479 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
Item
Unit
text
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
Medication Frequency
integer
C3476109 (UMLS CUI [1])
Code List
Medication 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 (8)
CL Item
Every 3 weeks (9)
CL Item
Evey 3 month (10)
CL Item
Every other day (11)
CL Item
Once a month (13)
Item
Medication Route
integer
C0013153 (UMLS CUI [1])
Code List
Medication Route
CL Item
Gastrostomy tube (3)
CL Item
Intra- arterial (6)
CL Item
Intralesional (8)
CL Item
Intramuscular (9)
CL Item
Intraperitoneal (14)
CL Item
Intrauterine (16)
CL Item
Subcutaneous (21)
Concomitant Medication Start Date | Pharmaceutical Preparations; Concomitant Therapy; Start time
Item
Concomitant Medication Start Date and Time
datetime
C2826734 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C1707479 (UMLS CUI [2,2])
C1301880 (UMLS CUI [2,3])
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])
Concomitant Medication Use Indication
Item
Primary Indication for Concomitant Medication
text
C2826696 (UMLS CUI [1])
Item
Drug Type
text
C0457591 (UMLS CUI [1])
Disease; Specification
Item
Specific Condition Name
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Date of onset
Item
Date of Onset
date
C0574845 (UMLS CUI [1])
Item
Is disease/ risk factor continuing?
text
C0012634 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0035648 (UMLS CUI [2,1])
C0549178 (UMLS CUI [2,2])
Code List
Is disease/ risk factor continuing?
Disease; Occurrence; Date in time | risk factors; Occurrence; Date in time
Item
If disease/ risk factors are not continuing, specify date of last occurence.
date
C0012634 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0035648 (UMLS CUI [2,1])
C2745955 (UMLS CUI [2,2])
C0011008 (UMLS CUI [2,3])
Medical History | risk factors
Item
Relevant Medical History/ Risk Factors not noted above
text
C0262926 (UMLS CUI [1])
C0035648 (UMLS CUI [2])
Item
Diagnostic Test Name
integer
C0430022 (UMLS CUI [1,1])
C2826273 (UMLS CUI [1,2])
Code List
Diagnostic Test Name
CL Item
Activated partial thromboplastin time (1)
CL Item
Alkaline phosphatase (3)
CL Item
Bilirubin direct (8)
CL Item
Bilirubin total (9)
CL Item
Blood myoglobin (10)
CL Item
Blood pressure (12)
CL Item
Blood urea nitrogen (13)
CL Item
Body temperature (14)
CL Item
CD4 lymphoctes (16)
CL Item
CD8 lymphocytes (17)
CL Item
Cholesterol total (19)
CL Item
C- reactive protein (20)
CL Item
Creatine phosphokinase (22)
CL Item
Creatine phosphokinase MB (23)
CL Item
Creatinine clearance (25)
CL Item
Diastolic blood pressure (26)
CL Item
Erythrocyte sedimentation rate (28)
CL Item
Fasting blood glucose (29)
CL Item
Gamme- glutamyltransferase (31)
CL Item
Glutamic- oxaloacetic transferase (32)
CL Item
Glumatic- pyruvate transaminase (33)
CL Item
HBV- DNA decreased (35)
CL Item
HBV- DNA increased (36)
CL Item
High density lipoprotein (40)
CL Item
HIV viral load (41)
CL Item
Lactic dehydrogenase (43)
CL Item
Low density lipoprotein (45)
CL Item
Mean cell hemoglobin concentration (48)
CL Item
Mean corpuscular volume (49)
CL Item
Oxygen saturation (52)
CL Item
Platelet count (56)
CL Item
Protein total (60)
CL Item
Prothrombin time (61)
CL Item
Red blood cell count (62)
CL Item
Respiratory rate (63)
CL Item
Reticulocyte count (64)
CL Item
Serum glucose (65)
CL Item
Serum uric acid (66)
CL Item
Systolic blood pressure (68)
CL Item
Thrombin time (69)
CL Item
Total lung capacity (70)
CL Item
Triglycerides (71)
CL Item
Urine myoglobin (75)
CL Item
Vital capacity (77)
CL Item
White blood cell count (78)
Test Date
Item
Test Date
date
C2826247 (UMLS CUI [1])
Test Result
Item
Test Result
text
C0456984 (UMLS CUI [1])
diagnostic procedure; Result
Item
Relevant diagnostic results not noted above
text
C0430022 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Item
If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) werde administered?
text
C0304229 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0034897 (UMLS CUI [1,3])
Code List
If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) werde administered?
CL Item
Unknown at this time (U)
CL Item
Not applicable (X)
Comment
Item
General Narrative Comments
text
C0947611 (UMLS CUI [1])