ID

38963

Beschreibung

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

Stichworte

Versionen (1)
  1. 16.11.19 16.11.19 -
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GlaxoSmithKline

Hochgeladen am

16. November 2019

DOI

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Creative Commons BY-NC 3.0
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Efficacy and Safety of GSK163090 in Subjects with Major Depressive Disorder; NCT00896363

Englisch

Discontinuation - Emergent Signs and Symptoms

1 Formulare  
Date of Assessment
Beschreibung

Date of Assessment

Alias
UMLS CUI-1
C2985720
Date of Assessment
Beschreibung

Assessment Date

Datentyp

date

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

[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
Beschreibung

Nervousness; Anxiety

Datentyp

text

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

Elevated mood

Datentyp

text

Alias
UMLS CUI [1]
C0233479
Irritability
Beschreibung

Irritable Mood

Datentyp

text

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

Mood, Worsening pattern

Datentyp

text

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

Anger, Sudden Onset

Datentyp

text

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

Panic Disorder; Panic Attacks

Datentyp

text

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

Crying

Datentyp

text

Alias
UMLS CUI [1]
C0010399
Agitation
Beschreibung

Agitation

Datentyp

text

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

Feelings, Detached

Datentyp

text

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

Confusion, Reduced Concentration

Datentyp

text

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

Forgetful

Datentyp

text

Alias
UMLS CUI [1]
C0542476
Mood swings
Beschreibung

Mood swings

Datentyp

text

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

Trouble Sleeping

Datentyp

text

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

Dreams, Increased; Nightmares, Increased

Datentyp

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
Beschreibung

Sweating, Increased

Datentyp

text

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

Trembling

Datentyp

text

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

Muscle Tension; Muscular stiffness

Datentyp

text

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

Myalgia

Datentyp

text

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

Restless Legs Syndrome

Datentyp

text

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

Muscle Cramp; Muscle movement involuntary

Datentyp

text

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

Fatigue

Datentyp

text

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

Gait, Unsteady; Incoordination

Datentyp

text

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

Blurred Vision

Datentyp

text

Alias
UMLS CUI [1]
C0344232
Sore eyes
Beschreibung

Sore eye

Datentyp

text

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

Oral region, Movement, Uncontrolled

Datentyp

text

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

Difficulty speaking

Datentyp

text

Alias
UMLS CUI [1]
C1527347
Headache
Beschreibung

Headache

Datentyp

text

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

Sialorrhea

Datentyp

text

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

Dizziness, Lightheadedness, Vertigo

Datentyp

text

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

Rhinorrhea

Datentyp

text

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

Dyspnea

Datentyp

text

Alias
UMLS CUI [1]
C0013404
Chills
Beschreibung

Chills

Datentyp

text

Alias
UMLS CUI [1]
C0085593
Fever
Beschreibung

Fever

Datentyp

text

Alias
UMLS CUI [1]
C0015967
Vomiting
Beschreibung

Vomiting

Datentyp

text

Alias
UMLS CUI [1]
C0042963
Nausea
Beschreibung

Nausea

Datentyp

text

Alias
UMLS CUI [1]
C0027497
Diarrhea
Beschreibung

Diarrhea

Datentyp

text

Alias
UMLS CUI [1]
C0011991
Stomach cramps
Beschreibung

Stomach cramps

Datentyp

text

Alias
UMLS CUI [1]
C0344375
Stomach bloating
Beschreibung

Stomach, Abdominal bloating

Datentyp

text

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

Visual disturbance

Datentyp

text

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

Burning sensation, Numbness or tingling

Datentyp

text

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

Sound sensitivity increased

Datentyp

text

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

Get Ringing or Buzzing in Ears

Datentyp

text

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

Taste Disorders; Smell Perception

Datentyp

text

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

Discontinuation - Emergent Signs and Symptoms

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Nervousness; Anxiety
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])
Elevated mood
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])
Irritable Mood
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])
Mood, Worsening pattern
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])
Anger, Sudden Onset
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])
Panic Disorder; Panic Attacks
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])
Crying
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])
Agitation
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])
Feelings, Detached
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])
Confusion, Reduced Concentration
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])
Forgetful
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])
Mood swings
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])
Trouble Sleeping
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])
Dreams, Increased; Nightmares, Increased
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])
Dreams, Increased; Nightmares, Increased
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])
Trembling
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])
Muscle Tension; Muscular stiffness
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])
Myalgia
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])
Restless Legs Syndrome
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])
Muscle Cramp; Muscle movement involuntary
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])
Fatigue
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])
Gait, Unsteady; Incoordination
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])
undefined item
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])
Sore eye
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])
Oral region, Movement, Uncontrolled
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])
Difficulty speaking
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])
Headache
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])
Sialorrhea
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])
Dizziness, Lightheadedness, Vertigo
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])
Rhinorrhea
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])
Dyspnea
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])
Chulls
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])
Fever
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])
Vomiting
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])
Nausea
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])
Diarrhea
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])
Stomach cramps
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])
Stomach, Abdominal bloating
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])
Visual disturbance
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])
Burning sensation, Numbness or tingling
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])
Sound sensitivity increased
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])
Get Ringing or Buzzing in Ears
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])
Taste Disorders; Smell Perception
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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