ID

29792

Description

Study ID: 101464 Clinical Study ID: SCA101464 Study Title: A Multicenter, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive Therapy to an Atypical Antipsychotic Agent(s) in Subjects with Schizophrenia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00086593 https://clinicaltrials.gov/ct2/show/NCT00086593 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Study Indication: Lamictal XR,Lamictal,LAMICTIN This ODM form contains Concomitant Medications.

Link

https://clinicaltrials.gov/ct2/show/NCT00086593

Keywords

Versions (1)
  1. 19/04/2018 19/04/2018 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

19 de abril de 2018

DOI

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License

Creative Commons BY-NC 3.0
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Evaluation of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive to Atypical Antipsychotic Agents in Schizophrenia NCT00086593

English

Concomitant Medications

1 forms  
Concomitant Medications
Description

Concomitant Medications

Alias
UMLS CUI-1
C2347852
Were any concomitant medications taken by the subject during the study?
Description

If Yes, complete the other Items of this Itemgroup.

Data type

text

Alias
UMLS CUI [1]
C2347852
Drug Name
Description

Record over-the-counter and prescription drugs prescribed. Trade names are preferred for all medications; this is particularly encouraged for all combination medications, e.g., multivitamins and cold medications. The subject should be encouraged to disclose all medications he/she is taking, including non-prescribed medications, herbal remedies, and nutritional supplements. If the subject is female, cross-check with the DEMOGRAPHY FOR FEMALES page that any contraceptive drugs taken by the subject are recorded.

Data type

text

Alias
UMLS CUI [1]
C2360065
Dose
Description

Dose

Data type

float

Alias
UMLS CUI [1]
C3174092
Units
Description

Units

Data type

text

Alias
UMLS CUI [1]
C2826646
Frequency
Description

Frequency

Data type

text

Alias
UMLS CUI [1]
C2826654
Route
Description

Route

Data type

text

Alias
UMLS CUI [1]
C2826730
Date Started
Description

If the concomitant medication start date is prior to the study start date, affirm ‘Was medication started pre-study?’.

Data type

date

Alias
UMLS CUI [1]
C2826734
Was medication started pre-study?
Description

If a concomitant medication was started pre-study, check that the indication is recorded on the CURRENT MEDICAL CONDITIONS page.

Data type

boolean

Alias
UMLS CUI [1]
C2981448
Date stopped
Description

Record the stop date if concomitant medication is stopped prior to the end of the study. If the subject is to continue taking the concomitant medication after the study is over, affirm ‘Was medication continued post-study?’.

Data type

date

Alias
UMLS CUI [1]
C2826744
Was medication continued post-study?
Description

Ongoing Medication

Data type

boolean

Alias
UMLS CUI [1]
C2826666
Conditions treated / Indication
Description

Conditions treated / Indication

Data type

text

Alias
UMLS CUI [1]
C2826696
Prophylaxis?
Description

Prophylaxis

Data type

text

Alias
UMLS CUI [1]
C0199176
Was drug administered for an adverse event?
Description

If the concomitant medication was taken for an adverse event, check that the event is entered on the appropriate ADVERSE EVENTS page(s) and that the dates are consistent with the event.

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2347852
Was drug administered as a rescue medication?
Description

Rescue medication

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0884980
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Similar models

Concomitant Medications

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Concomitant Medications
C2347852 (UMLS CUI-1)
Item
Were any concomitant medications taken by the subject during the study?
text
C2347852 (UMLS CUI [1])
Concomitant Medications
Code List
Were any concomitant medications taken by the subject during the study?
CL Item
Yes (Y)
CL Item
No (N)
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1])
Dose
Item
Dose
float
C3174092 (UMLS CUI [1])
Units
Item
Units
text
C2826646 (UMLS CUI [1])
Frequency
Item
Frequency
text
C2826654 (UMLS CUI [1])
Route
Item
Route
text
C2826730 (UMLS CUI [1])
Date Started
Item
Date Started
date
C2826734 (UMLS CUI [1])
Pre-study start
Item
Was medication started pre-study?
boolean
C2981448 (UMLS CUI [1])
Date stopped
Item
Date stopped
date
C2826744 (UMLS CUI [1])
Ongoing Medication
Item
Was medication continued post-study?
boolean
C2826666 (UMLS CUI [1])
Conditions treated / Indication
Item
Conditions treated / Indication
text
C2826696 (UMLS CUI [1])
Item
Prophylaxis?
text
C0199176 (UMLS CUI [1])
Prophylaxis
Code List
Prophylaxis?
CL Item
yes (Y)
CL Item
no (N)
Item
Was drug administered for an adverse event?
text
C0877248 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Concomitant Medications
Code List
Was drug administered for an adverse event?
CL Item
Yes (Y)
CL Item
No (N)
Item
Was drug administered as a rescue medication?
text
C0013227 (UMLS CUI [1,1])
C0884980 (UMLS CUI [1,2])
Concomitant Medications
Code List
Was drug administered as a rescue medication?
CL Item
Yes (Y)
CL Item
No (N)
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