Informações:
Falhas:
ID
29774
Descrição
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 Screen Part 2: Medical History.
Link
https://clinicaltrials.gov/ct2/show/NCT00086593
Palavras-chave
Versões (1)
- 19/04/2018 19/04/2018 - Sarah Riepenhausen
Titular dos direitos
GlaxoSmithKline
Transferido a
19 de abril de 2018
DOI
Para um pedido faça login.
Licença
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
Screen Part 2: Medical History
- StudyEvent: ODM
Similar models
Screen Part 2: Medical History
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Ear, nose and throat
Item
Past medical conditions: Ear, nose and throat
boolean
C0395797 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
Ear, nose and throat
Item
If subject has past medical conditions in Ear, nose and throat, specify conditions:
text
C0395797 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0262926 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Eyes
Item
Past medical conditions: Eyes
boolean
C0015397 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
Eyes
Item
If subject has past medical conditions of the eyes, specify:
text
C0015397 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0262926 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Respiratory
Item
Past medical conditions: Respiratory
boolean
C0035204 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
Respiratory
Item
If subject has past medical conditions of the respiratory tract, specify:
text
C0035204 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0262926 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Cardiovascular
Item
Past medical conditions: Cardiovascular
boolean
C0007222 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
Cardiovascular
Item
If subject has past medical condition of the cardiovascular system, specify:
text
C0007222 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0262926 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Gastrointestinal
Item
Past medical conditions: gastrointestinal
boolean
C0017178 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
Gastrointestinal
Item
If the subject has past medical conditions of the gastrointestinal tract, specify:
text
C0017178 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0262926 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Hepatobiliary and pancreas
Item
Past medical conditions: hepatobiliary and pancreas
boolean
C0267792 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0030286 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C0262926 (UMLS CUI [1,2])
C0030286 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
Hepatobiliary and pancreas
Item
If subject has past medical conditions of the hepatobiliary system and pancreas, specify:
text
C0267792 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0030286 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C1521902 (UMLS CUI [2,3])
C0262926 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0030286 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C1521902 (UMLS CUI [2,3])
Urinary system
Item
Past medical conditions: Urinary system
boolean
C0042075 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
Urinary system
Item
If subject has past medical conditions of the urinary system, specify:
text
C0042075 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0262926 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Reproductive system
Item
Past medical conditions: reproductive system
boolean
C0178829 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
Reproductive system
Item
If subject has past medical conditions of the reproductive system, specify:
text
C0178829 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0262926 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Neurology
Item
Past medical conditions: neurology
boolean
C0027765 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
Neurology
Item
If the subject has past medical, neurologic conditions, specify:
text
C0027765 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0262926 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Blood and lymphatic
Item
Past medical conditions: blood and lymphatic
boolean
C0851353 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
Blood and lymphatic
Item
If subject has past medical conditions of the blood and lymphatic system, specify:
text
C0851353 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0262926 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Endocrine and metabolic
Item
Past medical conditions: endocrine and metabolic
boolean
C0014130 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0025517 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C0262926 (UMLS CUI [1,2])
C0025517 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
Endocrine and metabolic
Item
If subject has past medical conditions of the endocrine and metabolic system, specify:
text
C0014130 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0025517 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C1521902 (UMLS CUI [2,3])
C0262926 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0025517 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C1521902 (UMLS CUI [2,3])
Musculoskeletal
Item
Past medical conditions: musculoskeletal
boolean
C0026857 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
Musculoskeletal
Item
If subject has past medical conditions of the musculoskeletal system, specify:
text
C0026857 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0262926 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Skin
Item
Past medical conditions: Skin
boolean
C1123023 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
Skin
Item
If subject has past medical conditions of the skin, specify:
text
C1123023 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0262926 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Psychiatry
Item
Past medical conditions: psychiatry
boolean
C0004936 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
Psychiatry
Item
If subject has past medical, psychiatric conditions, specify:
text
C0004936 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0262926 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Allergies
Item
Past medical conditions: Allergies
boolean
C0020517 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
Allergies
Item
If subject had allergies, specify:
text
C0020517 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0262926 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item Group
Current Medical Conditions (excluding the illness(es) being treted in the study).
C3899485 (UMLS CUI-1)
Ear, nose and throat
Item
Current medical conditions: Ear, nose and throat
boolean
C0395797 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,2])
Ear, nose and throat
Item
If subject has current medical conditions of the ear, nose and throat, specify:
text
C0395797 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0521116 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Eyes
Item
Current medical conditions: Eyes
boolean
C0015397 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,2])
Eyes
Item
If subject has current medical conditions of the eyes, specify:
text
C0015397 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0521116 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Respiratory
Item
Current medical conditions: Respiratory
boolean
C0035204 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,2])
Respiratory
Item
If subject has current medical conditions of the respiratory tract, specify:
text
C0035204 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0521116 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Cardiovascular
Item
Current medical conditions: Cardiovascular
boolean
C0007222 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,2])
Cardiovascular
Item
If subject has current medical conditions of the cardiovascular system, specify:
text
C0007222 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0521116 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Gastrointestinal
Item
Current medical conditions: Gastrointestinal
boolean
C0017178 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,2])
Gastrointestinal
Item
If subject has current medical conditions of the gastrointestinal tract, specify:
text
C0017178 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0521116 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Hepatobiliary and pancreas
Item
Current medical conditions: Hepatobiliary and pancreas
boolean
C0267792 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C0030286 (UMLS CUI [2,1])
C0521116 (UMLS CUI [2,2])
C0521116 (UMLS CUI [1,2])
C0030286 (UMLS CUI [2,1])
C0521116 (UMLS CUI [2,2])
Hepatobiliary and pancreas
Item
If subject has current medical conditions of the hepatobiliary system and pancreas, specify:
text
C0267792 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0030286 (UMLS CUI [2,1])
C0521116 (UMLS CUI [2,2])
C1521902 (UMLS CUI [2,3])
C0521116 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0030286 (UMLS CUI [2,1])
C0521116 (UMLS CUI [2,2])
C1521902 (UMLS CUI [2,3])
Urinary System
Item
Current medical conditions: Urinary System
boolean
C0042075 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,2])
Urinary System
Item
If subject has current medical conditions of the urinary system, specify:
text
C0042075 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0521116 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Reproductive System
Item
Current medical conditions: Reproductive System
boolean
C0178829 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,2])
Reproductive System
Item
If subject has current medical conditions of the reproductive system, specify:
text
C0178829 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0521116 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Neurology
Item
Current medical conditions: Neurology
boolean
C0027765 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,2])
Neurology
Item
If subject has current neurological conditions, specify:
text
C0027765 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0521116 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Blood and lymphatic
Item
Current medical conditions: Blood and lymphatic
boolean
C0851353 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,2])
Blood and lymphatic
Item
If subject has current medical conditions of the blood and lymphatic system, specify:
text
C0851353 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0521116 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Endocrine and Metabolic
Item
Current medical conditions: Endocrine and Metabolic
boolean
C0014130 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C0025517 (UMLS CUI [2,1])
C0521116 (UMLS CUI [2,2])
C0521116 (UMLS CUI [1,2])
C0025517 (UMLS CUI [2,1])
C0521116 (UMLS CUI [2,2])
Endocrine and Metabolic
Item
If subject has current medical conditions of the endocrine and metabolic sytems, specify:
text
C0014130 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0025517 (UMLS CUI [2,1])
C0521116 (UMLS CUI [2,2])
C1521902 (UMLS CUI [2,3])
C0521116 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0025517 (UMLS CUI [2,1])
C0521116 (UMLS CUI [2,2])
C1521902 (UMLS CUI [2,3])
Musculoskeletal
Item
Current medical conditions: Musculoskeletal
boolean
C0026857 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,2])
Musculoskeletal
Item
If subject has current medical conditions of the musculoskeletal system, specify:
text
C0026857 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0521116 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Skin
Item
Current medical conditions: Skin
boolean
C1123023 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,3])
Skin
Item
If subject has current medical conditions of the skin, specify:
text
C1123023 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
C0012634 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
Psychiatry
Item
Current medical conditions: Psychiatry
boolean
C0004936 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,2])
Psychiatry
Item
If subject has current psychiatric conditions, specify:
text
C0004936 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0521116 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Allergies
Item
Current medical conditions: Allergies
boolean
C0020517 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,2])
Allergies
Item
If subject has current allergies, specify:
text
C0020517 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0521116 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])