ID

34725

Beschrijving

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

Trefwoorden

Versies (4)
  1. 01-12-18 01-12-18 -
  2. 09-12-18 09-12-18 -
  3. 21-01-19 21-01-19 -
  4. 25-01-19 25-01-19 - Sarah Riepenhausen
Houder van rechten

GlaxoSmithKline

Geüploaded op

25 januari 2019

DOI

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Licentie

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

Engels

Concomitant Medication

1 Formulieren  
  1. StudyEvent: ODM
    1. Concomitant Medication
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Screening number
Beschrijving

Subject Screening No.

Datatype

integer

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

Subject Number

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Date Information Collected
Beschrijving

Date Information Collected

Datatype

date

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

Study Visit

Datatype

text

Alias
UMLS CUI [1]
C0545082
Concomitant Medication
Beschrijving

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.
Beschrijving

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

Datatype

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?
Beschrijving

Only applicable for the source document.

Datatype

boolean

Alias
UMLS CUI [1]
C2347852
Staff Initials
Beschrijving

Only applicable for the source document.

Datatype

text

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

Concomitant Medication Details

Alias
UMLS CUI-1
C2347852
Start Date
Beschrijving

Start Date

Datatype

date

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

If known

Datatype

datetime

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

Generic/Brand

Datatype

text

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

Dose

Datatype

text

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

Units

Datatype

text

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

Route

Datatype

text

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

Frequency

Datatype

text

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

Indication

Datatype

text

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

Medication Ongoing

Datatype

boolean

Alias
UMLS CUI [1]
C2826666
Conclusion
Beschrijving

Conclusion

Alias
UMLS CUI-1
C1707478
Physician's Initials
Beschrijving

Only applicable for the screening document.

Datatype

text

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

Only applicable for the source document.

Datatype

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 Formulieren
  1. StudyEvent: ODM
    1. Concomitant Medication
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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