ID
44092
Beschrijving
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 Week 12 - Visit 11 or Early Withdrawal.
Link
https://clinicaltrials.gov/ct2/show/NCT00086593
Trefwoorden
Versies (2)
- 19-04-18 19-04-18 - Sarah Riepenhausen
- 20-09-21 20-09-21 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
20 september 2021
DOI
Voor een aanvraag inloggen.
Licentie
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
Week 12 - Visit 11 or Early Withdrawal
- StudyEvent: ODM
Beschrijving
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschrijving
If assessments are taken on 2 separate dates for this visit, the Visit Date is the first date the subject is seen.
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0518766
Beschrijving
Record both; record sitting heart rate and blood pressure prior to recording standing heart rate and blood pressure.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1262869
- UMLS CUI [1,2]
- C0518766
Beschrijving
Systolic Blood Pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
Diastolic Blood Pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
Heart rate
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
Weight
Datatype
float
Maateenheden
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Beschrijving
Hair and skin
Datatype
text
Alias
- UMLS CUI [1,1]
- C0018494
- UMLS CUI [1,2]
- C0558035
Beschrijving
Hair and Skin
Datatype
text
Alias
- UMLS CUI [1,1]
- C0018494
- UMLS CUI [1,2]
- C0558035
- UMLS CUI [1,3]
- C1704258
Beschrijving
Lymph nodes
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0024204
Beschrijving
Lymph nodes
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0024204
- UMLS CUI [1,3]
- C1704258
Beschrijving
Eyes
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0200149
Beschrijving
Eyes
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0200149
- UMLS CUI [1,3]
- C1704258
Beschrijving
Ears, Nose and Throat
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0278350
Beschrijving
Ears, Nose and Throat
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0278350
- UMLS CUI [1,3]
- C1704258
Beschrijving
Breasts
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0199850
Beschrijving
Breasts
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0199850
- UMLS CUI [1,3]
- C1704258
Beschrijving
Respiratory
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0436121
Beschrijving
Respiratory
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0436121
- UMLS CUI [1,3]
- C1704258
Beschrijving
Cardiovascular
Datatype
text
Alias
- UMLS CUI [1]
- C3854344
Beschrijving
Cardiovascular
Datatype
text
Alias
- UMLS CUI [1,1]
- C3854344
- UMLS CUI [1,2]
- C1704258
Beschrijving
Abdomen
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0000726
Beschrijving
Abdomen
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0000726
- UMLS CUI [1,3]
- C1704258
Beschrijving
Urogenital
Datatype
text
Alias
- UMLS CUI [1]
- C1828035
Beschrijving
Urogenital
Datatype
text
Alias
- UMLS CUI [1,1]
- C1828035
- UMLS CUI [1,2]
- C1704258
Beschrijving
Pelvic
Datatype
text
Alias
- UMLS CUI [1]
- C0200045
Beschrijving
Pelvic
Datatype
text
Alias
- UMLS CUI [1,1]
- C0200045
- UMLS CUI [1,2]
- C1704258
Beschrijving
Rectal
Datatype
text
Alias
- UMLS CUI [1]
- C0199900
Beschrijving
Rectal
Datatype
text
Alias
- UMLS CUI [1,1]
- C0199900
- UMLS CUI [1,2]
- C1704258
Beschrijving
Musculoskeletal
Datatype
text
Alias
- UMLS CUI [1]
- C0475091
Beschrijving
Musculoskeletal
Datatype
text
Alias
- UMLS CUI [1,1]
- C0475091
- UMLS CUI [1,2]
- C1704258
Beschrijving
Neurological
Datatype
text
Alias
- UMLS CUI [1]
- C0027853
Beschrijving
Neurological
Datatype
text
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C1704258
Beschrijving
Mental status
Datatype
text
Alias
- UMLS CUI [1]
- C3260990
Beschrijving
Mental Status
Datatype
text
Alias
- UMLS CUI [1,1]
- C3260990
- UMLS CUI [1,2]
- C1704258
Beschrijving
Psychiatric Evaluation
Alias
- UMLS CUI-1
- C0846574
Beschrijving
Positive and Negative Syndrome Scale (PANSS)
Datatype
integer
Alias
- UMLS CUI [1]
- C0451383
Beschrijving
Positive and Negative Syndrome Scale (PANSS) - Positive Scale
Datatype
integer
Alias
- UMLS CUI [1]
- C0451383
Beschrijving
Positive and Negative Syndrome Scale (PANSS) - Negative Scale
Datatype
integer
Alias
- UMLS CUI [1]
- C0451383
Beschrijving
Positive and Negative Syndrome Scale (PANSS) - General Psychopathology
Datatype
integer
Alias
- UMLS CUI [1]
- C0451383
Beschrijving
5 Subdomains: Affective Flattening or Blunting Alogia Avolition - Apathy Anhedonia - Asociality Attention
Datatype
integer
Alias
- UMLS CUI [1,1]
- C4511599
- UMLS CUI [1,2]
- C0681889
- UMLS CUI [1,3]
- C0036341
Beschrijving
Calgary Depression Scale for Schizophrenia (CDSS)
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0679604
- UMLS CUI [1,2]
- C0036341
Beschrijving
Clinicians Global Impressions - Severity (CGI-S)
Datatype
integer
Alias
- UMLS CUI [1]
- C3639887
Beschrijving
Clinicians Global Impressions - Improvement (CGI-I)
Datatype
integer
Alias
- UMLS CUI [1]
- C3639888
Beschrijving
Brief Assessment of Cognition for Schizophrenia (BACS)
Datatype
integer
Alias
- UMLS CUI [1]
- C4055347
Beschrijving
Simpson Angus Scale
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0681889
- UMLS CUI [1,2]
- C0041755
- UMLS CUI [1,3]
- C0015371
Beschrijving
The Barnes Akathisia Scale
Datatype
integer
Alias
- UMLS CUI [1]
- C3541345
Beschrijving
Abnormal Involuntary Movement Scale (AIMS)
Datatype
integer
Alias
- UMLS CUI [1]
- C0450978
Beschrijving
Pharmacokinetic Sampling
Beschrijving
Sample No.: BLD006
Datatype
date
Alias
- UMLS CUI [1,1]
- C0178913
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0201734
Beschrijving
Sampling Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0005834
- UMLS CUI [1,3]
- C0201734
Beschrijving
Sample No.: BLD006
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0201734
Beschrijving
Atypical Antipsychotic Dosing
Alias
- UMLS CUI-1
- C0040615
- UMLS CUI-2
- C0205182
- UMLS CUI-3
- C0178602
Beschrijving
Drug Name
Datatype
text
Alias
- UMLS CUI [1,1]
- C2360065
- UMLS CUI [1,2]
- C1276996
Beschrijving
Taking
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1290952
- UMLS CUI [1,2]
- C1276996
Beschrijving
Date dose taken
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C1276996
Beschrijving
Time dose taken
Datatype
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C1276996
Beschrijving
Quality of Life Assessment
Alias
- UMLS CUI-1
- C0034380
Beschrijving
Investigational Product Dosing
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0678766
Similar models
Week 12 - Visit 11 or Early Withdrawal
- StudyEvent: ODM
C0518766 (UMLS CUI [1,2])
C0558035 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0024204 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0200149 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0278350 (UMLS CUI [1,2])
C0278350 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0199850 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0436121 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,2])
C0000726 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
C0681889 (UMLS CUI [1,2])
C0036341 (UMLS CUI [1,3])
C0036341 (UMLS CUI [1,2])
C0041755 (UMLS CUI [1,2])
C0015371 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0201734 (UMLS CUI [1,3])
C0005834 (UMLS CUI [1,2])
C0201734 (UMLS CUI [1,3])
C0201734 (UMLS CUI [1,2])
C0205182 (UMLS CUI-2)
C0178602 (UMLS CUI-3)
C1276996 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,2])
C1276996 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,2])
C1276996 (UMLS CUI [1,3])
C0678766 (UMLS CUI-2)
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])