Subject Screening No.
Item
Subject Screening number
integer
C0220908 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Subject Number
Item
Subject no.
integer
C2348585 (UMLS CUI [1])
Date Information Collected
Item
Date Information Collected
date
C3244127 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Past or Present Conditions or Surgical Procedures
Item
Any past and/or present conditions/surgical procedures associated with the following?
text
C0262926 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
Item
Organ System
integer
C0678852 (UMLS CUI [1])
CL Item
Cardiovascular system (1)
CL Item
Respiratory system (incl. influenza, asthma) (2)
CL Item
Gastrointestinal system (incl. indigestion, heartburn, bowel disorders, nausea, vomiting, diarrhoea) (3)
CL Item
Hepatic system (5)
CL Item
Endocrine system/metabolism (6)
CL Item
Neurological system (incl. convulsions, fits, blackouts) (7)
CL Item
Lymphatic system (8)
CL Item
Haematological system (9)
CL Item
Immunological system (incl. allergies, drug hypersensitivity) (10)
CL Item
Musculoskeletal system/connective tissue (11)
CL Item
Dermatological system (12)
CL Item
Genito-urinary system (13)
CL Item
Psychiatric function (14)
Past and or Present Conditions or Surgical Procedures
Item
Are any past and/or present conditions/surgical procedures associated with the following?
boolean
C0262926 (UMLS CUI [1])
C0543467 (UMLS CUI [2])
C1444637 (UMLS CUI [3,1])
C0009488 (UMLS CUI [3,2])
C0150312 (UMLS CUI [4,1])
C0009488 (UMLS CUI [4,2])
Specification
Item
Specification
text
C2348235 (UMLS CUI [1])
Medical History of Seizure, Brain Injury of Predisposition to Seizure
Item
Does the subject have a current or past history of any seizure disorder or brain injury or any condition which predisposes to seizure?
boolean
C0262926 (UMLS CUI [1,1])
C0036572 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0270611 (UMLS CUI [2,2])
C0220898 (UMLS CUI [3,1])
C0036572 (UMLS CUI [3,2])
Medical History of Seizure, Brain Injury of Predisposition to Seizure Comment
Item
If yes, give details concerning current or past history of any seizure disorder or brain injury or any condition which predisposes to seizure
text
C0262926 (UMLS CUI [1,1])
C0036572 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0270611 (UMLS CUI [2,2])
C0220898 (UMLS CUI [3,1])
C0036572 (UMLS CUI [3,2])
C0947611 (UMLS CUI [4])
Hypersensitivity to Lamotrigine
Item
Does the subject have a history of hypersensitivity to lamotrigine?
boolean
C0020517 (UMLS CUI [1,1])
C0064636 (UMLS CUI [1,2])
Hypersensitivity to Lamotrigine Comment
Item
If yes, give details concerning the history of hypersensitivity to lamotrigine
text
C0020517 (UMLS CUI [1,1])
C0064636 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
Recent Blood Donation
Item
Has the subject donated blood in excess of 500ml within 56 days prior to the first dose of study medication?
boolean
C0005794 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Recent Blood Donation Comment
Item
If yes, give details concerning blood donations in excess of 500ml within 56 days prior to the first dose of study medication
text
C0005794 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
Recent Study Participation with Investigational Drug
Item
Participation in a trial with and investigational drug within 30 days or 5 half lives (whichever is longer) prior to dosing
boolean
C2348568 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Recent Study Participation within Investigational Drug Comment
Item
If yes, give details concerning any participation in a trial with and investigational drug within 30 days or 5 half lives (whichever is longer) prior to dosing
text
C2348568 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
Physician's Initials
Item
Physician's Initials
text
C2986440 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])