ID

34725

Description

Study ID: 107434 Clinical Study ID: NAP107434 Study Title: A randomised, double-blind, double-dummy, placebo controlled, three-way cross-over study to investigate the effect of single oral doses of 100 mg GW273225 (4030W92) and 325 mg LAMICTAL on resting motor threshold in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Study Link: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW273225 Trade Name: lamictal Study Indication: Bipolar Disorder This form contains information about any concomitant medication the subject used during the study. It should be filled out at screening (, transcribed to the main form) and updated every visit. Screening Visit: 28 days prior to first dosing. Treatment Period: The day before dosing, until 48h after dosing. Follow-Up: 14-21 days after last dose

Keywords

Versions (4)
  1. 12/1/18 12/1/18 -
  2. 12/9/18 12/9/18 -
  3. 1/21/19 1/21/19 -
  4. 1/25/19 1/25/19 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

January 25, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Effect of Lamictal on Resting Motor Threshold Study-ID 107434

English

Concomitant Medication

1 forms  
  1. StudyEvent: ODM
    1. Concomitant Medication
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Screening number
Description

Subject Screening No.

Data type

integer

Alias
UMLS CUI [1,1]
C0220908
UMLS CUI [1,2]
C0600091
Subject no.
Description

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Date Information Collected
Description

Date Information Collected

Data type

date

Alias
UMLS CUI [1,1]
C3244127
UMLS CUI [1,2]
C0011008
Study Visit
Description

Study Visit

Data type

text

Alias
UMLS CUI [1]
C0545082
Concomitant Medication
Description

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Has the subject taken received prescribed or non-prescribed medication (including vitamins, herbal remedies and antacids) within 7 days prior to the screening day, which in the opinion of the principal/co-investigator, may interfere with the study procedures or comprise safety.
Description

If yes, record details below. Paracetamol for mild analgesia may be permitted This item only applies to the screening visit.

Data type

text

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C3166216
UMLS CUI [2,1]
C0332185
UMLS CUI [2,2]
C0013231
UMLS CUI [3,1]
C0332257
UMLS CUI [3,2]
C0042890
UMLS CUI [4,1]
C0332257
UMLS CUI [4,2]
C1360419
UMLS CUI [5,1]
C0332257
UMLS CUI [5,2]
C0003138
Did the subject take any Concomitant Medication?
Description

Only applicable for the source document.

Data type

boolean

Alias
UMLS CUI [1]
C2347852
Staff Initials
Description

Only applicable for the source document.

Data type

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C1552089
Concomitant Medication Details
Description

Concomitant Medication Details

Alias
UMLS CUI-1
C2347852
Start Date
Description

Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C2347852
Start Time
Description

If known

Data type

datetime

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C2347852
Medication
Description

Generic/Brand

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2347852
Dose
Description

Dose

Data type

text

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C2347852
Units
Description

Units

Data type

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C2347852
Route
Description

Route

Data type

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C2347852
Frequency
Description

Frequency

Data type

text

Alias
UMLS CUI [1,1]
C3476109
UMLS CUI [1,2]
C2347852
Indication
Description

Indication

Data type

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C2347852
Medication Ongoing
Description

Medication Ongoing

Data type

boolean

Alias
UMLS CUI [1]
C2826666
Conclusion
Description

Conclusion

Alias
UMLS CUI-1
C1707478
Physician's Initials
Description

Only applicable for the screening document.

Data type

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C0031831
Transcribed from source data by (enter staff initials)
Description

Only applicable for the source document.

Data type

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C1552089
UMLS CUI [1,3]
C4554264
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Similar models

Concomitant Medication

1 forms
  1. StudyEvent: ODM
    1. Concomitant Medication
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
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])
Item
Study Visit
text
C0545082 (UMLS CUI [1])
Study Visit
Code List
Study Visit
CL Item
Screening (Screening)
CL Item
Source Document (Source Document)
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
Item
Has the subject taken received prescribed or non-prescribed medication (including vitamins, herbal remedies and antacids) within 7 days prior to the screening day, which in the opinion of the principal/co-investigator, may interfere with the study procedures or comprise safety.
text
C0332185 (UMLS CUI [1,1])
C3166216 (UMLS CUI [1,2])
C0332185 (UMLS CUI [2,1])
C0013231 (UMLS CUI [2,2])
C0332257 (UMLS CUI [3,1])
C0042890 (UMLS CUI [3,2])
C0332257 (UMLS CUI [4,1])
C1360419 (UMLS CUI [4,2])
C0332257 (UMLS CUI [5,1])
C0003138 (UMLS CUI [5,2])
Prescribed or Non-Prescribed Medication, including Vitamins, Herbal Remedies and Antacids
Code List
Has the subject taken received prescribed or non-prescribed medication (including vitamins, herbal remedies and antacids) within 7 days prior to the screening day, which in the opinion of the principal/co-investigator, may interfere with the study procedures or comprise safety.
CL Item
No (No)
CL Item
Yes (Yes)
CL Item
N/A (N/A)
Concomiant Medication
Item
Did the subject take any Concomitant Medication?
boolean
C2347852 (UMLS CUI [1])
Staff Initials
Item
Staff Initials
text
C2986440 (UMLS CUI [1,1])
C1552089 (UMLS CUI [1,2])
Item Group
Concomitant Medication Details
C2347852 (UMLS CUI-1)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Start Time
Item
Start Time
datetime
C1301880 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Medication
Item
Medication
text
C0013227 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Dose
Item
Dose
text
C3174092 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Units
Item
Units
text
C1519795 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Route
Item
Route
text
C0013153 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Frequency
Item
Frequency
text
C3476109 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Indication
Item
Indication
text
C3146298 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Medication Ongoing
Item
Medication Ongoing
boolean
C2826666 (UMLS CUI [1])
Item Group
Conclusion
C1707478 (UMLS CUI-1)
Physician's Initials
Item
Physician's Initials
text
C2986440 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])
Transcription, Staff Initials
Item
Transcribed from source data by (enter staff initials)
text
C2986440 (UMLS CUI [1,1])
C1552089 (UMLS CUI [1,2])
C4554264 (UMLS CUI [1,3])
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