ID

38963

Description

Study ID: 109035 Clinical Study ID: 109035 Study Title: A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy and Safety of GSK163090 in Subjects With Major Depressive Disorder Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00896363 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK163090 1 mg, GSK163090 Placebo, GSK163090 3 mg Trade Name: Study Indication: Depressive Disorder

Mots-clés

  1. 16.11.19 16.11.19 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

16. November 2019

DOI

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Licence

Creative Commons BY-NC 3.0

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    Efficacy and Safety of GSK163090 in Subjects with Major Depressive Disorder; NCT00896363

    Discontinuation - Emergent Signs and Symptoms

    Date of Assessment
    Description

    Date of Assessment

    Alias
    UMLS CUI-1
    C2985720
    Date of Assessment
    Description

    Assessment Date

    Type de données

    date

    Alias
    UMLS CUI [1]
    C2985720
    [during the past 7 days] have you experienced any changes in the following symptoms?
    Description

    [during the past 7 days] have you experienced any changes in the following symptoms?

    Alias
    UMLS CUI-1
    C0457454
    UMLS CUI-2
    C1457887
    Nervousness or anxiety
    Description

    Nervousness; Anxiety

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0027769
    UMLS CUI [2]
    C0003467
    Elevated mood, feeling high
    Description

    Elevated mood

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0233479
    Irritability
    Description

    Irritable Mood

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0022107
    Sudden worsening of mood
    Description

    Mood, Worsening pattern

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0026516
    UMLS CUI [1,2]
    C0332271
    Sudden outbursts of anger ("anger attacks")
    Description

    Anger, Sudden Onset

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0002957
    UMLS CUI [1,2]
    C1272517
    Sudden panic or anxiety attacks
    Description

    Panic Disorder; Panic Attacks

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0030319
    UMLS CUI [2]
    C0086769
    Bouts of crying or tearfulness
    Description

    Crying

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0010399
    Agitation
    Description

    Agitation

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0085631
    Feeling unreal or detached
    Description

    Feelings, Detached

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1527305
    UMLS CUI [1,2]
    C0687118
    Confusion or trouble concentrating
    Description

    Confusion, Reduced Concentration

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0009676
    UMLS CUI [2]
    C0424099
    Forgetfulness or problems with memory
    Description

    Forgetful

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0542476
    Mood swings
    Description

    Mood swings

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0085633
    Trouble sleeping, insomnia
    Description

    Trouble Sleeping

    Type de données

    text

    Alias
    UMLS CUI [1]
    C3641752
    Increased dreaming or nightmares
    Description

    Dreams, Increased; Nightmares, Increased

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0013117
    UMLS CUI [1,2]
    C0205217
    UMLS CUI [2,1]
    C0028084
    UMLS CUI [2,2]
    C0205217
    Sweating more than usual
    Description

    Sweating, Increased

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0038990
    UMLS CUI [1,2]
    C0205217
    Shaking, trembling
    Description

    Trembling

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0234369
    Muscle tension or stiffness
    Description

    Muscle Tension; Muscular stiffness

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0427195
    UMLS CUI [2]
    C0221170
    Muscle aches or pains
    Description

    Myalgia

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0231528
    Restless feelings in legs
    Description

    Restless Legs Syndrome

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0035258
    Muscle cramps, spasms or twitching
    Description

    Muscle Cramp; Muscle movement involuntary

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0026821
    UMLS CUI [2]
    C0221722
    Fatigue, tiredness
    Description

    Fatigue

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0015672
    Unsteady gait or incoordination
    Description

    Gait, Unsteady; Incoordination

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0231686
    UMLS CUI [2]
    C0520966
    Blurred vision
    Description

    Blurred Vision

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0344232
    Sore eyes
    Description

    Sore eye

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0578687
    Uncontrollable mouth/tongue movements
    Description

    Oral region, Movement, Uncontrolled

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0230028
    UMLS CUI [1,2]
    C0026649
    UMLS CUI [1,3]
    C0205318
    Problems with speech or speaking clearly
    Description

    Difficulty speaking

    Type de données

    text

    Alias
    UMLS CUI [1]
    C1527347
    Headache
    Description

    Headache

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0018681
    Increased saliva in mouth
    Description

    Sialorrhea

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0037036
    Dizziness, lightheadedness, or sensation of spinning (vertigo)
    Description

    Dizziness, Lightheadedness, Vertigo

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0012833
    UMLS CUI [1,2]
    C0220870
    UMLS CUI [1,3]
    C0042571
    Nose running
    Description

    Rhinorrhea

    Type de données

    text

    Alias
    UMLS CUI [1]
    C1260880
    Shortness of breath, gasping for air
    Description

    Dyspnea

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0013404
    Chills
    Description

    Chills

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0085593
    Fever
    Description

    Fever

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0015967
    Vomiting
    Description

    Vomiting

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0042963
    Nausea
    Description

    Nausea

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0027497
    Diarrhea
    Description

    Diarrhea

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0011991
    Stomach cramps
    Description

    Stomach cramps

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0344375
    Stomach bloating
    Description

    Stomach, Abdominal bloating

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0038351
    UMLS CUI [1,2]
    C1291077
    Unusual visual sensations (lights, colors, geometric shapes, etc.)
    Description

    Visual disturbance

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0547030
    Burning, numbness, tingling sensation
    Description

    Burning sensation, Numbness or tingling

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0085624
    UMLS CUI [2]
    C3842982
    Unusual sensitivity to sound
    Description

    Sound sensitivity increased

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2938899
    Ringing or noises in the ears
    Description

    Get Ringing or Buzzing in Ears

    Type de données

    text

    Alias
    UMLS CUI [1]
    C3829985
    Unusual taste or smells
    Description

    Taste Disorders; Smell Perception

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0549590
    UMLS CUI [1,2]
    C0037361

    Similar models

    Discontinuation - Emergent Signs and Symptoms

    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Date of Assessment
    C2985720 (UMLS CUI-1)
    Assessment Date
    Item
    Date of Assessment
    date
    C2985720 (UMLS CUI [1])
    Item Group
    [during the past 7 days] have you experienced any changes in the following symptoms?
    C0457454 (UMLS CUI-1)
    C1457887 (UMLS CUI-2)
    Item
    Nervousness or anxiety
    text
    C0027769 (UMLS CUI [1])
    C0003467 (UMLS CUI [2])
    Code List
    Nervousness or anxiety
    CL Item
    New symptom (1)
    CL Item
    Old symptom but worse (2)
    CL Item
    Old symptom but improved (3)
    CL Item
    Old symptom but unchanged or symptom not present (4)
    Item
    Elevated mood, feeling high
    text
    C0233479 (UMLS CUI [1])
    Code List
    Elevated mood, feeling high
    CL Item
    New symptom (1)
    CL Item
    Old symptom but worse (2)
    CL Item
    Old symptom but improved (3)
    CL Item
    Old symptom but unchanged or symptom not present (4)
    Item
    Irritability
    text
    C0022107 (UMLS CUI [1])
    Code List
    Irritability
    CL Item
    New symptom (1)
    CL Item
    Old symptom but worse (2)
    CL Item
    Old symptom but improved (3)
    CL Item
    Old symptom but unchanged or symptom not present (4)
    Item
    Sudden worsening of mood
    text
    C0026516 (UMLS CUI [1,1])
    C0332271 (UMLS CUI [1,2])
    Code List
    Sudden worsening of mood
    CL Item
    New symptom (1)
    CL Item
    Old symptom but worse (2)
    CL Item
    Old symptom but improved (3)
    CL Item
    Old symptom but unchanged or symptom not present (4)
    Item
    Sudden outbursts of anger ("anger attacks")
    text
    C0002957 (UMLS CUI [1,1])
    C1272517 (UMLS CUI [1,2])
    Code List
    Sudden outbursts of anger ("anger attacks")
    CL Item
    New symptom (1)
    CL Item
    Old symptom but worse (2)
    CL Item
    Old symptom but improved (3)
    CL Item
    Old symptom but unchanged or symptom not present (4)
    Item
    Sudden panic or anxiety attacks
    text
    C0030319 (UMLS CUI [1])
    C0086769 (UMLS CUI [2])
    Code List
    Sudden panic or anxiety attacks
    CL Item
    New symptom (1)
    CL Item
    Old symptom but worse (2)
    CL Item
    Old symptom but improved (3)
    CL Item
    Old symptom but unchanged or symptom not present (4)
    Item
    Bouts of crying or tearfulness
    text
    C0010399 (UMLS CUI [1])
    Code List
    Bouts of crying or tearfulness
    CL Item
    New symptom (1)
    CL Item
    Old symptom but worse (2)
    CL Item
    Old symptom but improved (3)
    CL Item
    Old symptom but unchanged or symptom not present (4)
    Item
    Agitation
    text
    C0085631 (UMLS CUI [1])
    Code List
    Agitation
    CL Item
    New symptom (1)
    CL Item
    Old symptom but worse (2)
    CL Item
    Old symptom but improved (3)
    CL Item
    Old symptom but unchanged or symptom not present (4)
    Item
    Feeling unreal or detached
    text
    C1527305 (UMLS CUI [1,1])
    C0687118 (UMLS CUI [1,2])
    Code List
    Feeling unreal or detached
    CL Item
    New symptom (1)
    CL Item
    Old symptom but worse (2)
    CL Item
    Old symptom but improved (3)
    CL Item
    Old symptom but unchanged or symptom not present (4)
    Item
    Confusion or trouble concentrating
    text
    C0009676 (UMLS CUI [1])
    C0424099 (UMLS CUI [2])
    Code List
    Confusion or trouble concentrating
    CL Item
    New symptom (1)
    CL Item
    Old symptom but worse (2)
    CL Item
    Old symptom but improved (3)
    CL Item
    Old symptom but unchanged or symptom not present (4)
    Item
    Forgetfulness or problems with memory
    text
    C0542476 (UMLS CUI [1])
    Code List
    Forgetfulness or problems with memory
    CL Item
    New symptom (1)
    CL Item
    Old symptom but worse (2)
    CL Item
    Old symptom but improved (3)
    CL Item
    Old symptom but unchanged or symptom not present (4)
    Item
    Mood swings
    text
    C0085633 (UMLS CUI [1])
    Code List
    Mood swings
    CL Item
    New symptom (1)
    CL Item
    Old symptom but worse (2)
    CL Item
    Old symptom but improved (3)
    CL Item
    Old symptom but unchanged or symptom not present (4)
    Item
    Trouble sleeping, insomnia
    text
    C3641752 (UMLS CUI [1])
    Code List
    Trouble sleeping, insomnia
    CL Item
    New symptom (1)
    CL Item
    Old symptom but worse (2)
    CL Item
    Old symptom but improved (3)
    CL Item
    Old symptom but unchanged or symptom not present (4)
    Item
    Increased dreaming or nightmares
    text
    C0013117 (UMLS CUI [1,1])
    C0205217 (UMLS CUI [1,2])
    C0028084 (UMLS CUI [2,1])
    C0205217 (UMLS CUI [2,2])
    Code List
    Increased dreaming or nightmares
    CL Item
    New symptom (1)
    CL Item
    Old symptom but worse (2)
    CL Item
    Old symptom but improved (3)
    CL Item
    Old symptom but unchanged or symptom not present (4)
    Item
    Sweating more than usual
    text
    C0038990 (UMLS CUI [1,1])
    C0205217 (UMLS CUI [1,2])
    Code List
    Sweating more than usual
    CL Item
    New symptom (1)
    CL Item
    Old symptom but worse (2)
    CL Item
    Old symptom but improved (3)
    CL Item
    Old symptom but unchanged or symptom not present (4)
    Item
    Shaking, trembling
    text
    C0234369 (UMLS CUI [1])
    Code List
    Shaking, trembling
    CL Item
    New symptom (1)
    CL Item
    Old symptom but worse (2)
    CL Item
    Old symptom but improved (3)
    CL Item
    Old symptom but unchanged or symptom not present (4)
    Item
    Muscle tension or stiffness
    text
    C0427195 (UMLS CUI [1])
    C0221170 (UMLS CUI [2])
    Code List
    Muscle tension or stiffness
    CL Item
    New symptom (1)
    CL Item
    Old symptom but worse (2)
    CL Item
    Old symptom but improved (3)
    CL Item
    Old symptom but unchanged or symptom not present (4)
    Item
    Muscle aches or pains
    text
    C0231528 (UMLS CUI [1])
    Code List
    Muscle aches or pains
    CL Item
    New symptom (1)
    CL Item
    Old symptom but worse (2)
    CL Item
    Old symptom but improved (3)
    CL Item
    Old symptom but unchanged or symptom not present (4)
    Item
    Restless feelings in legs
    text
    C0035258 (UMLS CUI [1])
    Code List
    Restless feelings in legs
    CL Item
    New symptom (1)
    CL Item
    Old symptom but worse (2)
    CL Item
    Old symptom but improved (3)
    CL Item
    Old symptom but unchanged or symptom not present (4)
    Item
    Muscle cramps, spasms or twitching
    text
    C0026821 (UMLS CUI [1])
    C0221722 (UMLS CUI [2])
    Code List
    Muscle cramps, spasms or twitching
    CL Item
    New symptom (1)
    CL Item
    Old symptom but worse (2)
    CL Item
    Old symptom but improved (3)
    CL Item
    Old symptom but unchanged or symptom not present (4)
    Item
    Fatigue, tiredness
    text
    C0015672 (UMLS CUI [1])
    Code List
    Fatigue, tiredness
    CL Item
    New symptom (1)
    CL Item
    Old symptom but worse (2)
    CL Item
    Old symptom but improved (3)
    CL Item
    Old symptom but unchanged or symptom not present (4)
    Item
    Unsteady gait or incoordination
    text
    C0231686 (UMLS CUI [1])
    C0520966 (UMLS CUI [2])
    Code List
    Unsteady gait or incoordination
    CL Item
    New symptom (1)
    CL Item
    Old symptom but worse (2)
    CL Item
    Old symptom but improved (3)
    CL Item
    Old symptom but unchanged or symptom not present (4)
    Item
    Blurred vision
    text
    C0344232 (UMLS CUI [1])
    Code List
    Blurred vision
    CL Item
    New symptom (1)
    CL Item
    Old symptom but worse (2)
    CL Item
    Old symptom but improved (3)
    CL Item
    Old symptom but unchanged or symptom not present (4)
    Item
    Sore eyes
    text
    C0578687 (UMLS CUI [1])
    Code List
    Sore eyes
    CL Item
    New symptom (1)
    CL Item
    Old symptom but worse (2)
    CL Item
    Old symptom but improved (3)
    CL Item
    Old symptom but unchanged or symptom not present (4)
    Item
    Uncontrollable mouth/tongue movements
    text
    C0230028 (UMLS CUI [1,1])
    C0026649 (UMLS CUI [1,2])
    C0205318 (UMLS CUI [1,3])
    Code List
    Uncontrollable mouth/tongue movements
    CL Item
    New symptom (1)
    CL Item
    Old symptom but worse (2)
    CL Item
    Old symptom but improved (3)
    CL Item
    Old symptom but unchanged or symptom not present (4)
    Item
    Problems with speech or speaking clearly
    text
    C1527347 (UMLS CUI [1])
    Code List
    Problems with speech or speaking clearly
    CL Item
    New symptom (1)
    CL Item
    Old symptom but worse (2)
    CL Item
    Old symptom but improved (3)
    CL Item
    Old symptom but unchanged or symptom not present (4)
    Item
    Headache
    text
    C0018681 (UMLS CUI [1])
    Code List
    Headache
    CL Item
    New symptom (1)
    CL Item
    Old symptom but worse (2)
    CL Item
    Old symptom but improved (3)
    CL Item
    Old symptom but unchanged or symptom not present (4)
    Item
    Increased saliva in mouth
    text
    C0037036 (UMLS CUI [1])
    Code List
    Increased saliva in mouth
    CL Item
    New symptom (1)
    CL Item
    Old symptom but worse (2)
    CL Item
    Old symptom but improved (3)
    CL Item
    Old symptom but unchanged or symptom not present (4)
    Item
    Dizziness, lightheadedness, or sensation of spinning (vertigo)
    text
    C0012833 (UMLS CUI [1,1])
    C0220870 (UMLS CUI [1,2])
    C0042571 (UMLS CUI [1,3])
    Code List
    Dizziness, lightheadedness, or sensation of spinning (vertigo)
    CL Item
    New symptom (1)
    CL Item
    Old symptom but worse (2)
    CL Item
    Old symptom but improved (3)
    CL Item
    Old symptom but unchanged or symptom not present (4)
    Item
    Nose running
    text
    C1260880 (UMLS CUI [1])
    Code List
    Nose running
    CL Item
    New symptom (1)
    CL Item
    Old symptom but worse (2)
    CL Item
    Old symptom but improved (3)
    CL Item
    Old symptom but unchanged or symptom not present (4)
    Item
    Shortness of breath, gasping for air
    text
    C0013404 (UMLS CUI [1])
    Code List
    Shortness of breath, gasping for air
    CL Item
    New symptom (1)
    CL Item
    Old symptom but worse (2)
    CL Item
    Old symptom but improved (3)
    CL Item
    Old symptom but unchanged or symptom not present (4)
    Item
    Chills
    text
    C0085593 (UMLS CUI [1])
    Code List
    Chills
    CL Item
    New symptom (1)
    CL Item
    Old symptom but worse (2)
    CL Item
    Old symptom but improved (3)
    CL Item
    Old symptom but unchanged or symptom not present (4)
    Item
    Fever
    text
    C0015967 (UMLS CUI [1])
    Code List
    Fever
    CL Item
    New symptom (1)
    CL Item
    Old symptom but worse (2)
    CL Item
    Old symptom but improved (3)
    CL Item
    Old symptom but unchanged or symptom not present (4)
    Item
    Vomiting
    text
    C0042963 (UMLS CUI [1])
    Code List
    Vomiting
    CL Item
    New symptom (1)
    CL Item
    Old symptom but worse (2)
    CL Item
    Old symptom but improved (3)
    CL Item
    Old symptom but unchanged or symptom not present (4)
    Item
    Nausea
    text
    C0027497 (UMLS CUI [1])
    Code List
    Nausea
    CL Item
    New symptom (1)
    CL Item
    Old symptom but worse (2)
    CL Item
    Old symptom but improved (3)
    CL Item
    Old symptom but unchanged or symptom not present (4)
    Item
    Diarrhea
    text
    C0011991 (UMLS CUI [1])
    Code List
    Diarrhea
    CL Item
    New symptom (1)
    CL Item
    Old symptom but worse (2)
    CL Item
    Old symptom but improved (3)
    CL Item
    Old symptom but unchanged or symptom not present (4)
    Item
    Stomach cramps
    text
    C0344375 (UMLS CUI [1])
    Code List
    Stomach cramps
    CL Item
    New symptom (1)
    CL Item
    Old symptom but worse (2)
    CL Item
    Old symptom but improved (3)
    CL Item
    Old symptom but unchanged or symptom not present (4)
    Item
    Stomach bloating
    text
    C0038351 (UMLS CUI [1,1])
    C1291077 (UMLS CUI [1,2])
    Code List
    Stomach bloating
    CL Item
    New symptom (1)
    CL Item
    Old symptom but worse (2)
    CL Item
    Old symptom but improved (3)
    CL Item
    Old symptom but unchanged or symptom not present (4)
    Item
    Unusual visual sensations (lights, colors, geometric shapes, etc.)
    text
    C0547030 (UMLS CUI [1])
    Code List
    Unusual visual sensations (lights, colors, geometric shapes, etc.)
    CL Item
    New symptom (1)
    CL Item
    Old symptom but worse (2)
    CL Item
    Old symptom but improved (3)
    CL Item
    Old symptom but unchanged or symptom not present (4)
    Item
    Burning, numbness, tingling sensation
    text
    C0085624 (UMLS CUI [1])
    C3842982 (UMLS CUI [2])
    Code List
    Burning, numbness, tingling sensation
    CL Item
    New symptom (1)
    CL Item
    Old symptom but worse (2)
    CL Item
    Old symptom but improved (3)
    CL Item
    Old symptom but unchanged or symptom not present (4)
    Item
    Unusual sensitivity to sound
    text
    C2938899 (UMLS CUI [1])
    Code List
    Unusual sensitivity to sound
    CL Item
    New symptom (1)
    CL Item
    Old symptom but worse (2)
    CL Item
    Old symptom but improved (3)
    CL Item
    Old symptom but unchanged or symptom not present (4)
    Item
    Ringing or noises in the ears
    text
    C3829985 (UMLS CUI [1])
    Code List
    Ringing or noises in the ears
    CL Item
    New symptom (1)
    CL Item
    Old symptom but worse (2)
    CL Item
    Old symptom but improved (3)
    CL Item
    Old symptom but unchanged or symptom not present (4)
    Item
    Unusual taste or smells
    text
    C0549590 (UMLS CUI [1,1])
    C0037361 (UMLS CUI [1,2])
    Code List
    Unusual taste or smells
    CL Item
    New symptom (1)
    CL Item
    Old symptom but worse (2)
    CL Item
    Old symptom but improved (3)
    CL Item
    Old symptom but unchanged or symptom not present (4)

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