ID

22227

Description

A Randomized, Multicenter, Double-Blind, Non-inferiority Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Subjects With Schizophrenia Study Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT01515423 Sponsor: Janssen Research & Development, LLC Other drug name: TREVICTA®

Link

https://clinicaltrials.gov/ct2/show/NCT01515423

Keywords

  1. 5/23/17 5/23/17 -
Uploaded on

May 23, 2017

DOI

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License

Creative Commons BY 4.0

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Unscheduled Visit - CRFs Paliperidone Palmitate Schizophrenia NCT01515423

Unscheduled Visit - CRFs Paliperidone Palmitate Schizophrenia NCT01515423

Date of visit
Description

Date of visit

Alias
UMLS CUI-1
C1320303
Visit date
Description

Date of visit

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1]
C1320303
dd.mm.yyyy
ECG
Description

ECG

Alias
UMLS CUI-1
C1623258
ECG reference number
Description

ECG reference number

Data type

integer

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C3274661
Vital Signs with Weight, Waist and Temperature
Description

Vital Signs with Weight, Waist and Temperature

Alias
UMLS CUI-1
C0518766
Body Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Waist Circumference
Description

Waist Circumference

Data type

float

Measurement units
  • cm
Alias
UMLS CUI [1]
C0455829
cm
Temperature
Description

Temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0039476
°C
Supine after 5 minutes rest: Pulse
Description

Pulse at rest

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1,1]
C0232117
UMLS CUI [1,2]
C0443144
beats/min
Supine after 5 minutes rest: Systolic Blood Pressure
Description

SBP at rest

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C2039694
mmHg
Supine after 5 minutes rest: Diastolic Blood Pressure
Description

DBP at rest

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C2183311
mmHg
Standing after 2 minutes: Pulse
Description

Pulse while standing

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C2029905
beats/min
Standing after 2 minutes: Systolic Blood Pressure
Description

SBP standing

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C1303018
mmHg
Standing after 2 minutes: Diastolic Blood Pressure
Description

DBP standing

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C1303019
mmHg
Actual Position
Description

Patient position finding

Data type

integer

Alias
UMLS CUI [1]
C0449850
PK Blood Sample: Paliperidone
Description

PK Blood Sample: Paliperidone

Alias
UMLS CUI-1
C0201734
UMLS CUI-2
C0178913
UMLS CUI-3
C0753678
Specimen taken
Description

Specimen taken

Data type

boolean

Alias
UMLS CUI [1]
C1277698
Accession number
Description

Accession number

Data type

integer

Alias
UMLS CUI [1,1]
C1510755
UMLS CUI [1,2]
C2826726
Specimen comments, if any
Description

Comment, blood specimen

Data type

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0178913
Lab Sample Central Lab
Description

Lab Sample Central Lab

Alias
UMLS CUI-1
C3244292
Accession number
Description

Accession number

Data type

integer

Alias
UMLS CUI [1,1]
C1510755
UMLS CUI [1,2]
C2826726
Urine Dipstick Pregnancy Test
Description

Urine Dipstick Pregnancy Test

Alias
UMLS CUI-1
C0430056
Was the Dipstick Pregnancy Test performed?
Description

Dipstick Pregnancy Test

Data type

integer

Alias
UMLS CUI [1]
C0430056
If No, please provide a reason:
Description

Reason for no pregnancy test

Data type

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C3841220
UMLS CUI [1,3]
C0032976
Dipstick Pregnancy Test Result
Description

Pregnancy Test Result

Data type

integer

Alias
UMLS CUI [1]
C0427777
Abnormal Involuntary Movement Scale
Description

Abnormal Involuntary Movement Scale

Alias
UMLS CUI-1
C0450978
Facial and oral movements: Muscles of facial expression
Description

AIMS: Muscles of facial expression

Data type

integer

Alias
UMLS CUI [1]
C3640439
Facial and oral movements: Lips and perioral area
Description

AIMS: Lips and perioral area

Data type

integer

Alias
UMLS CUI [1]
C3640440
Facial and oral movements: Jaw
Description

AIMS: Jaw

Data type

integer

Alias
UMLS CUI [1]
C3640441
Facial and oral movements: Tongue
Description

AIMS: Tongue

Data type

integer

Alias
UMLS CUI [1]
C3640442
Extremity movements: Upper (arms, wrists, hands, fingers)
Description

AIMS: Upper arm

Data type

integer

Alias
UMLS CUI [1]
C3640443
Extremity movements: Lower (legs, knees, ankles, toes)
Description

AIMS: Lower extremities

Data type

integer

Alias
UMLS CUI [1]
C3640444
Trunk movements: Neck, shoulders, hip
Description

AIMS: Neck, shoulders, hip

Data type

integer

Alias
UMLS CUI [1]
C3640445
Global Judgements: Severity of abnormal movements
Description

AIMS: Severity of abnormal movements

Data type

integer

Alias
UMLS CUI [1]
C3640446
Global Judgements: Incapacitation due to abnormal movements
Description

AIMS: Incapacitation due to abnormal movements

Data type

integer

Alias
UMLS CUI [1]
C3640447
Global Judgements: Subject´s awareness of abnormal movements
Description

AIMS: Subject´s awareness of abnormal movements

Data type

integer

Alias
UMLS CUI [1]
C3640448
Dental Status: Current problems with teeth and/or dentures
Description

AIMS: Current problems with teeth and/or dentures

Data type

integer

Alias
UMLS CUI [1]
C3640449
Dental Status: Does the subject usually wear dentures?
Description

AIMS: Does the subject usually wear dentures?

Data type

boolean

Alias
UMLS CUI [1]
C3640450
Barnes Akathisia Rating Scale
Description

Barnes Akathisia Rating Scale

Alias
UMLS CUI-1
C3541345
Objective
Description

BARS: Objective

Data type

integer

Alias
UMLS CUI [1]
C3640451
Subjective: Awareness of restlessness
Description

BARS: Awareness of restlessness

Data type

integer

Alias
UMLS CUI [1]
C3640452
Subjective: Reported distress related to restlessness
Description

BARS: Reported distress related to restlessness

Data type

integer

Alias
UMLS CUI [1]
C3640453
Global clinical rating of akathisia
Description

BARS: Global clinical rating of akathisia

Data type

integer

Alias
UMLS CUI [1]
C3640454
Simpson Angus Rating Scale
Description

Simpson Angus Rating Scale

Alias
UMLS CUI-1
C0030569
UMLS CUI-2
C0450973
1 Gait
Description

Gait

Data type

integer

Alias
UMLS CUI [1,1]
C0016928
UMLS CUI [1,2]
C0450973
2 Arm Dropping
Description

Arm dropping

Data type

integer

Alias
UMLS CUI [1,1]
C0231650
UMLS CUI [1,2]
C0450973
3 Shoulder shaking
Description

Shoulder shaking

Data type

integer

Alias
UMLS CUI [1,1]
C0037004
UMLS CUI [1,2]
C1883023
UMLS CUI [1,3]
C0450973
4 Elbow rigidity
Description

Elbow rigidity

Data type

integer

Alias
UMLS CUI [1,1]
C0013769
UMLS CUI [1,2]
C0858572
UMLS CUI [1,3]
C0450973
5 Wrist rigidity
Description

Wrist rigidity

Data type

integer

Alias
UMLS CUI [1,1]
C0043262
UMLS CUI [1,2]
C0858572
UMLS CUI [1,3]
C0450973
6 Leg pendulousness
Description

Leg pendulousness

Data type

integer

Alias
UMLS CUI [1,1]
C1140621
UMLS CUI [1,2]
C4068836
UMLS CUI [1,3]
C0450973
7 Head dropping
Description

Head dropping

Data type

integer

Alias
UMLS CUI [1,1]
C0018670
UMLS CUI [1,2]
C1705648
UMLS CUI [1,3]
C0450973
8 Glabella tap
Description

Glabella tap

Data type

integer

Alias
UMLS CUI [1,1]
C0576550
UMLS CUI [1,2]
C0450973
9 Tremor
Description

Tremor

Data type

integer

Alias
UMLS CUI [1,1]
C0040822
UMLS CUI [1,2]
C0450973
10 Salivation
Description

Salivation

Data type

integer

Alias
UMLS CUI [1,1]
C0036104
UMLS CUI [1,2]
C0450973
Columbia - Suicide Severity Rating Scale (C-SSRS) Since Last Visit Version
Description

Columbia - Suicide Severity Rating Scale (C-SSRS) Since Last Visit Version

Alias
UMLS CUI-1
C3641328
Suicidal Ideation: Wish to be dead
Description

SSRS: Wish to be dead

Data type

boolean

Alias
UMLS CUI [1]
C3641578
Suicidal Ideation: If ´Yes´, describe:
Description

SSRS: Description of wish to be dead

Data type

text

Alias
UMLS CUI [1]
C3641579
Suicidal Ideation: Non-specific active suicidal thoughts
Description

SSRS: Non-specific active suicidal thoughts

Data type

boolean

Alias
UMLS CUI [1]
C3641580
Suicidal Ideation: If ´Yes´, describe:
Description

SSRS: Description of Non-Specific Active Suicidal Thoughts

Data type

text

Alias
UMLS CUI [1]
C3641581
Suicidal Ideation: Active suicidal ideation with any methods (not plan) without intent to act
Description

SSRS: Active suicidal ideation with any methods (not plan) without intent to act

Data type

boolean

Alias
UMLS CUI [1]
C3641582
Suicidal Ideation: If ´Yes´, describe:
Description

SSRS: Description of Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act

Data type

text

Alias
UMLS CUI [1]
C3641583
Suicidal Ideation: Active suicidal ideation with some intent to act, without specific plan
Description

SSRS: Active suicidal ideation with some intent to act, without specific plan

Data type

boolean

Alias
UMLS CUI [1]
C3641605
Suicidal Ideation: If ´Yes´, describe:
Description

SSRS: Description of Active Suicidal Ideation with Some Intent to Act, without Specific Plan

Data type

text

Alias
UMLS CUI [1]
C3641606
Suicidal Ideation: Active suicidal ideation with specific plan and intent
Description

SSRS: Active suicidal ideation with specific plan and intent

Data type

boolean

Alias
UMLS CUI [1]
C3641607
Suicidal Ideation: If ´Yes´, describe:
Description

SSRS: Description of Active Suicidal Ideation with Specific Plan and Intent

Data type

text

Alias
UMLS CUI [1]
C3641584
Intensity of Ideation: Most Severe Ideation
Description

SSRS: Most Severe Ideation

Data type

integer

Alias
UMLS CUI [1]
C3641585
Intensity of Ideation: Description of Most Severe Ideation
Description

SSRS: Description of Ideation

Data type

text

Alias
UMLS CUI [1]
C3641586
Intensity of Ideation: Frequency of Most Severe Ideation
Description

SSRS: Frequency

Data type

integer

Alias
UMLS CUI [1]
C3641587
Intensity of Ideation: Duration of Most Severe Ideation
Description

SSRS: Duration

Data type

integer

Alias
UMLS CUI [1]
C3641588
Intensity of Ideation: Controllability of Most Severe Ideation
Description

SSRS: Controllability

Data type

integer

Alias
UMLS CUI [1]
C3641589
Intensity of Ideation: Deterrents to Most Severe Ideation
Description

SSRS: Deterrents

Data type

integer

Alias
UMLS CUI [1]
C3641590
Intensity of Ideation: Reasons for Most Severe Ideation
Description

SSRS: Reasons for ideation

Data type

integer

Alias
UMLS CUI [1]
C3641591
Suicidal Behavior: Actual attempt
Description

SSRS: Actual Suicide Attempt

Data type

boolean

Alias
UMLS CUI [1]
C3641592
Suicidal Behavior: If ´Yes´, specify total number of attempts:
Description

SSRS: Number of Actual Suicide Attempts

Data type

integer

Alias
UMLS CUI [1]
C3641593
Suicidal Behavior: If ´Yes´, describe:
Description

SSRS: Description of Actual Suicide Attempts

Data type

text

Alias
UMLS CUI [1]
C3641594
Suicidal Behavior: Non-suicidal self-injurious behavior
Description

SSRS: Non-suicidal self-injurious behavior

Data type

boolean

Alias
UMLS CUI [1]
C3641595
Suicidal Behavior: Interrupted attempt
Description

SSRS: Interrupted Suicide Attempt

Data type

boolean

Alias
UMLS CUI [1]
C3641596
Suicidal Behavior: If ´Yes´, specify total number of interrupted attempts:
Description

SSRS: Number of Interrupted Suicide Attempts

Data type

integer

Alias
UMLS CUI [1]
C3641597
Suicidal Behavior: If ´Yes´, describe:
Description

SSRS: Description of Interrupted Suicide Attempts

Data type

text

Alias
UMLS CUI [1]
C3641598
Suicidal Behavior: Aborted attempt
Description

SSRS: Aborted Suicide Attempt

Data type

boolean

Alias
UMLS CUI [1]
C3641599
Suicidal Behavior: If ´Yes´, specify total number of aborted attempts:
Description

SSRS: Number of Aborted Suicide Attempts

Data type

integer

Alias
UMLS CUI [1]
C3641600
Suicidal Behavior: If ´Yes´, describe:
Description

SSRS: Description of Aborted Suicide Attempt

Data type

text

Alias
UMLS CUI [1]
C3641601
Suicidal Behavior: Preparatory acts or behavior toward suicide attempt
Description

SSRS: Preparatory Acts or Behaviors Toward Suicide Attempt

Data type

boolean

Alias
UMLS CUI [1]
C3641602
Suicidal Behavior: If ´Yes´, describe:
Description

SSRS: Description of Preparatory Acts or Behaviors Toward Suicide Attempt

Data type

text

Alias
UMLS CUI [1]
C3641603
Suicidal Behavior
Description

SSRS: Suicidal Behavior

Data type

boolean

Alias
UMLS CUI [1]
C3641604
Completed suicide
Description

SSRS: Completed suicide

Data type

boolean

Alias
UMLS CUI [1]
C3641338
Suicidal Behavior - Actual Attempts: Most lethal attempt date
Description

SSRS: Most Lethal Suicide Attempt Date

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1]
C3641339
dd.mm.yyyy
Suicidal Behavior - Actual Attempts: Most Lethal Suicide Attempt actual lethality/medical damage
Description

SSRS: Most Lethal Suicide Attempt Damage

Data type

integer

Alias
UMLS CUI [1]
C3641340
Suicidal Behavior - Actual Attempts: Most Lethal Suicide Attempt potential lethality
Description

SSRS: Most Lethal Suicide Attempt Potential

Data type

integer

Alias
UMLS CUI [1]
C3641341
Investigator Evaluation of lnjection site
Description

Investigator Evaluation of lnjection site

Alias
UMLS CUI-1
C0035173
UMLS CUI-2
C0220825
UMLS CUI-3
C2700396
Rater's initials
Description

Rater's initials

Data type

text

Alias
UMLS CUI [1]
C3166278
Time of evaluation
Description

Time of evaluation

Data type

time

Measurement units
  • hh:mm
Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0220825
UMLS CUI [1,3]
C2700396
hh:mm
Redness
Description

Redness of injection site

Data type

integer

Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C2700396
Swelling
Description

Swelling of injection site

Data type

integer

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C2700396
Induration
Description

Induration of injection site

Data type

integer

Alias
UMLS CUI [1,1]
C0332534
UMLS CUI [1,2]
C2700396
Subject Evaluation of lnjection site
Description

Subject Evaluation of lnjection site

Alias
UMLS CUI-1
C0030705
UMLS CUI-2
C0220825
UMLS CUI-3
C2700396
Time of evaluation
Description

Time of evaluation

Data type

time

Measurement units
  • hh:mm
Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0220825
UMLS CUI [1,3]
C2700396
hh:mm
Injection pain
Description

Injection pain

Data type

boolean

Alias
UMLS CUI [1]
C0151828
Positive and Negative Syndrome Scale for Schizophrenia
Description

Positive and Negative Syndrome Scale for Schizophrenia

Alias
UMLS CUI-1
C4086747
UMLS CUI-2
C0036341
Rater's initials
Description

Rater's initials

Data type

text

Alias
UMLS CUI [1]
C3166278
Positive subscale: P01 Delusions
Description

PANSS: Delusions

Data type

integer

Alias
UMLS CUI [1]
C4087066
Positive subscale: P02 Conceptual disorganization
Description

PANSS: Conceptual disorganization

Data type

integer

Alias
UMLS CUI [1]
C4086687
Positive subscale: P03 Hallucinatory behavior
Description

PANSS: Hallucinatory behavior

Data type

integer

Alias
UMLS CUI [1]
C4086696
Positive subscale: P04 Excitement
Description

PANSS: Excitement

Data type

integer

Alias
UMLS CUI [1]
C4086693
Positive subscale: P05 Grandiosity
Description

PANSS: Grandiosity

Data type

integer

Alias
UMLS CUI [1]
C4086694
Positive subscale: P06 Suspiciousness/persecution
Description

PANSS: Suspiciousness/persecution

Data type

integer

Alias
UMLS CUI [1]
C4087067
Positive subscale: P07 Hostility
Description

PANSS: Hostility

Data type

integer

Alias
UMLS CUI [1]
C4086697
Negative subscale: N01 Blunted affect
Description

PANSS: Blunted affect

Data type

integer

Alias
UMLS CUI [1]
C4086686
Negative subscale: N02 Emotional withdrawal
Description

PANSS: Emotional withdrawal

Data type

integer

Alias
UMLS CUI [1]
C4086692
Negative subscale: N03 Poor rapport
Description

PANSS: Poor rapport

Data type

integer

Alias
UMLS CUI [1]
C4086705
Negative subscale: N04 Passive/apathetic social withdrawal
Description

PANSS: Passive/apathetic social withdrawal

Data type

integer

Alias
UMLS CUI [1]
C4086702
Negative subscale: N05 Difficulty in abstract thinking
Description

PANSS: Difficulty in abstract thinking

Data type

integer

Alias
UMLS CUI [1]
C4086689
Negative subscale: N06 Lack of spontaneity and flow of conversation
Description

PANSS: Lack of spontaneity and flow of conversation

Data type

integer

Alias
UMLS CUI [1]
C4086699
Negative subscale: N07 Stereotyped thinking
Description

PANSS: Stereotyped thinking

Data type

integer

Alias
UMLS CUI [1]
C4086708
General psychopathology subscale: G01 Somatic concern
Description

PANSS: Somatic concern

Data type

integer

Alias
UMLS CUI [1]
C4086707
General psychopathology subscale: G02 Anxiety
Description

PANSS: Anxiety

Data type

integer

Alias
UMLS CUI [1]
C4086685
General psychopathology subscale: G03 Guilt feelings
Description

PANSS: Guilt feelings

Data type

integer

Alias
UMLS CUI [1]
C4086695
General psychopathology subscale: G04 Tension
Description

PANSS: Tension

Data type

integer

Alias
UMLS CUI [1]
C4086709
General psychopathology subscale: G05 Mannerisms and posturing
Description

PANSS: Mannerisms and posturing

Data type

integer

Alias
UMLS CUI [1]
C4086700
General psychopathology subscale: G06 Depression
Description

PANSS: Depression

Data type

integer

Alias
UMLS CUI [1]
C4086688
General psychopathology subscale: G07 Motor retardation
Description

PANSS: Motor retardation

Data type

integer

Alias
UMLS CUI [1]
C4086701
General psychopathology subscale: G08 Uncooperativeness
Description

PANSS: Uncooperativeness

Data type

integer

Alias
UMLS CUI [1]
C4086710
General psychopathology subscale: G09 Unusual thought content
Description

PANSS: Unusual thought content

Data type

integer

Alias
UMLS CUI [1]
C4086711
General psychopathology subscale: G10 Disorientation
Description

PANSS: Disorientation

Data type

integer

Alias
UMLS CUI [1]
C4086690
General psychopathology subscale: G11 Poor attention
Description

PANSS: Poor attention

Data type

integer

Alias
UMLS CUI [1]
C4086703
General psychopathology subscale: G12 Lack of judgment and insight
Description

PANSS: Lack of judgment and insight

Data type

integer

Alias
UMLS CUI [1]
C4086698
General psychopathology subscale: G13 Disturbance of volition
Description

PANSS: Disturbance of volition

Data type

integer

Alias
UMLS CUI [1]
C4086691
General psychopathology subscale: G14 Poor impulse control
Description

PANSS: Poor impulse control

Data type

integer

Alias
UMLS CUI [1]
C4086704
General psychopathology subscale: G15 Preoccupation
Description

PANSS: Preoccupation

Data type

integer

Alias
UMLS CUI [1]
C4086706
General psychopathology subscale: G16 Active social avoidence
Description

PANSS: Active social avoidence

Data type

integer

Alias
UMLS CUI [1]
C4086684
Calculated total PANSS score
Description

Calculated total PANSS score

Data type

integer

Alias
UMLS CUI [1,1]
C4086747
UMLS CUI [1,2]
C0449820
Mini Positive and Negative Syndrome Scale for Schizophrenia
Description

Mini Positive and Negative Syndrome Scale for Schizophrenia

Alias
UMLS CUI-1
C1282927
UMLS CUI-2
C4086747
UMLS CUI-3
C0036341
Rater's initials
Description

Rater's initials

Data type

text

Alias
UMLS CUI [1]
C3166278
Positive subscale: P01 Delusions
Description

PANSS: Delusions

Data type

integer

Alias
UMLS CUI [1]
C4087066
Positive subscale: P02 Conceptual disorganization
Description

PANSS: Conceptual disorganization

Data type

integer

Alias
UMLS CUI [1]
C4086687
Positive subscale: P03 Hallucinatory behavior
Description

PANSS: Hallucinatory behavior

Data type

integer

Alias
UMLS CUI [1]
C4086696
Positive subscale: P06 Suspiciousness/persecution
Description

PANSS: Suspiciousness/persecution

Data type

integer

Alias
UMLS CUI [1]
C4087067
Positive subscale: P07 Hostility
Description

PANSS: Hostility

Data type

integer

Alias
UMLS CUI [1]
C4086697
General psychopathology subscale: G08 Uncooperativeness
Description

PANSS: Uncooperativeness

Data type

integer

Alias
UMLS CUI [1]
C4086710
Clinical Global Impression - Severity
Description

Clinical Global Impression - Severity

Alias
UMLS CUI-1
C3639708
Rater´s initials
Description

Rater´s initials

Data type

text

Alias
UMLS CUI [1]
C3166278
Considering your total clinical experience with this particular population, how severe is the subject's psychotic disorder at this time?
Description

Clinical global impression of subject's psychotic disorder

Data type

integer

Alias
UMLS CUI [1]
C3698629
Personal and Social Performance Scale
Description

Personal and Social Performance Scale

Alias
UMLS CUI-1
C0450973
UMLS CUI-2
C0037397
Rater's initials
Description

Rater's initials

Data type

text

Alias
UMLS CUI [1]
C3166278
Domain of functioning: Socially useful activities, including work and study
Description

Socially useful activities, including work and study

Data type

integer

Alias
UMLS CUI [1]
C3641834
Domain of functioning: Personal and social relationships
Description

Personal and social relationships

Data type

integer

Alias
UMLS CUI [1]
C0021797
Domain of functioning: Self-care
Description

Self-care

Data type

integer

Alias
UMLS CUI [1]
C0474417
Domain of functioning: Disturbing and aggressive behaviors
Description

Disturbing and aggressive behaviors

Data type

integer

Alias
UMLS CUI [1]
C0001807
Total score
Description

Total score

Data type

integer

Alias
UMLS CUI [1]
C2964552
Evaluation of relapse
Description

Evaluation of relapse

Alias
UMLS CUI-1
C0220825
UMLS CUI-2
C0035020
1.Since the last visit, has the subject had a psychiatric hospitalization (involuntary or voluntary admission to a psychiatric hospital for decompensation of the subject´s schizophrenic symptoms)
Description

Psychiatric hospitalization

Data type

boolean

Alias
UMLS CUI [1]
C0748061
If `yes`, please enter date of psychiatric hospitalization:
Description

Psychiatric hospitalization date

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0748061
UMLS CUI [1,2]
C0011008
dd.mm.yyyy
2.Worsening: A. An increase of >= 25% in total PANSS score from randomization if the score at randomization was >40.
Description

Worsening of schizophrenic symptoms, PANSS

Data type

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C1546960
UMLS CUI [1,3]
C4086747
If `yes`, please enter date:
Description

Date, worsening of schizophrenic symptoms

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0036341
UMLS CUI [1,3]
C1546960
dd.mm.yyyy
2.Worsening: B. A 10 point increase in total PANSS score from randomization if the score at randomization was <= 40
Description

Worsening of schizophrenic symptoms, PANSS

Data type

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C1546960
UMLS CUI [1,3]
C4086747
If `yes`, please enter date:
Description

Date, worsening of schizophrenic symptoms

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0036341
UMLS CUI [1,3]
C1546960
dd.mm.yyyy
3.Since the last visit, has the subject had a deliberate self-injury or exhibited violent behavior resulting in suicide, clinically significant injury to him/her self or another person or significant property damage?
Description

Self-injury, physical aggression

Data type

boolean

Alias
UMLS CUI [1,1]
C0178360
UMLS CUI [1,2]
C0424323
If `yes`, please enter date of event:
Description

Date of self-injury or physical aggression

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0178360
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0424323
dd.mm.yyyy
If `yes`, describe the event:
Description

Specification self-injury or physical aggression

Data type

integer

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C0178360
UMLS CUI [1,3]
C0424323
4.Since the last visit, has the subject had a suicidal or homicidal ideation and aggressive behavior that was clinically significant (in frequency and severity) in the investigator´s judgment?
Description

Suicidal or homicidal ideation, aggressive behavior

Data type

boolean

Alias
UMLS CUI [1,1]
C0749133
UMLS CUI [1,2]
C0455204
UMLS CUI [1,3]
C0001807
If `yes`, please enter date of event:
Description

Date of suicidal or homicidal ideation, aggressive behavior

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0749133
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0455204
UMLS CUI [1,5]
C0011008
UMLS CUI [1,6]
C0001807
dd.mm.yyyy
If `yes`, describe the event:
Description

Specification of suicidal or homicidal ideation, aggressive behavior

Data type

integer

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C0749133
UMLS CUI [1,3]
C0455204
UMLS CUI [1,4]
C0001807
5.Worsening of any one of the following PANSS items: P1 (delusions), P2 (conceptual disorganization), P3 (hallucinatory behavior), P6 (suspiciousness/persecution), P7 (hostility) or G8 (uncooperativeness) to: A. A score of >= 5 after randomization on any of the above PANSS items if the maximum score for the above PANSS items was <= 3 at randomization
Description

Worsening of schizophrenic symptoms, PANSS

Data type

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C1546960
UMLS CUI [1,3]
C4086747
If `yes`, please enter date:
Description

Date, worsening of schizophrenic symptoms

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0036341
UMLS CUI [1,3]
C1546960
dd.mm.yyyy
5.Worsening of any one of the following PANSS items: P1 (delusions), P2 (conceptual disorganization), P3 (hallucinatory behavior), P6 (suspiciousness/persecution), P7 (hostility) or G8 (uncooperativeness) to: B. A score of >= 6 after randomization on any of the above PANSS items if the maximum score for the above PANSS items was = 4 at randomization
Description

Worsening of schizophrenic symptoms, PANSS

Data type

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C1546960
UMLS CUI [1,3]
C4086747
If `yes`, please enter date:
Description

Date, worsening of schizophrenic symptoms

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0036341
UMLS CUI [1,3]
C1546960
dd.mm.yyyy
Unscheduled Forms: Please select assessments performed at this unscheduled visit
Description

Unscheduled Forms: Please select assessments performed at this unscheduled visit

Alias
UMLS CUI-1
C3854240
UMLS CUI-2
C0376315
PK Blood Sample
Description

PK Blood Sample

Data type

boolean

Alias
UMLS CUI [1,1]
C0201734
UMLS CUI [1,2]
C0178913
Positive and Negative Syndrome Scale for Schizophrenia
Description

Positive and Negative Syndrome Scale for Schizophrenia

Data type

boolean

Alias
UMLS CUI [1,1]
C4086747
UMLS CUI [1,2]
C0036341
Simpson Angus Rating Scale
Description

Simpson Angus Rating Scale

Data type

boolean

Alias
UMLS CUI [1,1]
C0030569
UMLS CUI [1,2]
C0450973
Abnormal Involuntary Movement Scale
Description

Abnormal Involuntary Movement Scale

Data type

boolean

Alias
UMLS CUI [1]
C0450978
Barnes Akathisia Rating Scale
Description

Barnes Akathisia Rating Scale

Data type

boolean

Alias
UMLS CUI [1]
C3541345
Personal and Social Performance Scale
Description

Personal and Social Performance Scale

Data type

boolean

Alias
UMLS CUI [1,1]
C0450973
UMLS CUI [1,2]
C0037397
Evaluation of Relapse
Description

Evaluation of Relapse

Data type

boolean

Alias
UMLS CUI [1,1]
C0220825
UMLS CUI [1,2]
C0035020
Vital Signs with Weight, Waist and Temperature
Description

Vital Signs with Weight, Waist and Temperature

Data type

boolean

Alias
UMLS CUI [1]
C0518766
Urine Dipstick Pregnancy Test
Description

Urine Dipstick Pregnancy Test

Data type

boolean

Alias
UMLS CUI [1]
C0430056
Clinical Global Impression - Severity
Description

Clinical Global Impression - Severity

Data type

boolean

Alias
UMLS CUI [1]
C3639708
Mini-Positive and Negative Syndrome Scale for Schizophrenia
Description

Mini Positive and Negative Syndrome Scale for Schizophrenia

Data type

boolean

Alias
UMLS CUI [1,1]
C1282927
UMLS CUI [1,2]
C4086747
UMLS CUI [1,3]
C0036341
Columbia - Suicide Severity Rating Scale (C-SSRS) Since Last Visit
Description

Columbia - Suicide Severity Rating Scale (C-SSRS) Since Last Visit

Data type

boolean

Alias
UMLS CUI [1]
C3641328
Investigator Evaluation of Injection site
Description

Investigator Evaluation of Injection site

Data type

boolean

Alias
UMLS CUI [1,1]
C0035173
UMLS CUI [1,2]
C0220825
UMLS CUI [1,3]
C2700396
Subject Evaluation of Injection site
Description

Subject Evaluation of Injection site

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0220825
UMLS CUI [1,3]
C2700396
Lab Sample Central Lab
Description

Lab Sample Central Lab

Data type

boolean

Alias
UMLS CUI [1]
C3244292
ECG
Description

ECG

Data type

boolean

Alias
UMLS CUI [1]
C1623258

Similar models

Unscheduled Visit - CRFs Paliperidone Palmitate Schizophrenia NCT01515423

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Date of visit
C1320303 (UMLS CUI-1)
Date of visit
Item
Visit date
date
C1320303 (UMLS CUI [1])
Item Group
ECG
C1623258 (UMLS CUI-1)
ECG reference number
Item
ECG reference number
integer
C1623258 (UMLS CUI [1,1])
C3274661 (UMLS CUI [1,2])
Item Group
Vital Signs with Weight, Waist and Temperature
C0518766 (UMLS CUI-1)
Weight
Item
Body Weight
float
C0005910 (UMLS CUI [1])
Waist Circumference
Item
Waist Circumference
float
C0455829 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0039476 (UMLS CUI [1])
Pulse at rest
Item
Supine after 5 minutes rest: Pulse
integer
C0232117 (UMLS CUI [1,1])
C0443144 (UMLS CUI [1,2])
SBP at rest
Item
Supine after 5 minutes rest: Systolic Blood Pressure
integer
C2039694 (UMLS CUI [1])
DBP at rest
Item
Supine after 5 minutes rest: Diastolic Blood Pressure
integer
C2183311 (UMLS CUI [1])
Pulse while standing
Item
Standing after 2 minutes: Pulse
integer
C2029905 (UMLS CUI [1])
SBP standing
Item
Standing after 2 minutes: Systolic Blood Pressure
integer
C1303018 (UMLS CUI [1])
DBP standing
Item
Standing after 2 minutes: Diastolic Blood Pressure
integer
C1303019 (UMLS CUI [1])
Item
Actual Position
integer
C0449850 (UMLS CUI [1])
Code List
Actual Position
CL Item
Standing (1)
CL Item
Sitting (2)
CL Item
Supine (3)
Item Group
PK Blood Sample: Paliperidone
C0201734 (UMLS CUI-1)
C0178913 (UMLS CUI-2)
C0753678 (UMLS CUI-3)
Specimen taken
Item
Specimen taken
boolean
C1277698 (UMLS CUI [1])
Accession number
Item
Accession number
integer
C1510755 (UMLS CUI [1,1])
C2826726 (UMLS CUI [1,2])
Comment, blood specimen
Item
Specimen comments, if any
text
C0947611 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
Item Group
Lab Sample Central Lab
C3244292 (UMLS CUI-1)
Accession number
Item
Accession number
integer
C1510755 (UMLS CUI [1,1])
C2826726 (UMLS CUI [1,2])
Item Group
Urine Dipstick Pregnancy Test
C0430056 (UMLS CUI-1)
Item
Was the Dipstick Pregnancy Test performed?
integer
C0430056 (UMLS CUI [1])
Code List
Was the Dipstick Pregnancy Test performed?
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (postmenopausal females) (3)
Reason for no pregnancy test
Item
If No, please provide a reason:
text
C0566251 (UMLS CUI [1,1])
C3841220 (UMLS CUI [1,2])
C0032976 (UMLS CUI [1,3])
Item
Dipstick Pregnancy Test Result
integer
C0427777 (UMLS CUI [1])
Code List
Dipstick Pregnancy Test Result
CL Item
Positive (1)
CL Item
Negative (2)
Item Group
Abnormal Involuntary Movement Scale
C0450978 (UMLS CUI-1)
Item
Facial and oral movements: Muscles of facial expression
integer
C3640439 (UMLS CUI [1])
Code List
Facial and oral movements: Muscles of facial expression
CL Item
0: None (1)
CL Item
1: Minimal (2)
CL Item
2: Mild (3)
CL Item
3: Moderate (4)
CL Item
4: Severe (5)
Item
Facial and oral movements: Lips and perioral area
integer
C3640440 (UMLS CUI [1])
Code List
Facial and oral movements: Lips and perioral area
CL Item
0: None (1)
CL Item
1: Minimal (2)
CL Item
2: Mild (3)
CL Item
3: Moderate (4)
CL Item
4: Severe (5)
Item
Facial and oral movements: Jaw
integer
C3640441 (UMLS CUI [1])
Code List
Facial and oral movements: Jaw
CL Item
0: None (1)
CL Item
1: Minimal (2)
CL Item
2: Mild (3)
CL Item
3: Moderate (4)
CL Item
4: Severe (5)
Item
Facial and oral movements: Tongue
integer
C3640442 (UMLS CUI [1])
Code List
Facial and oral movements: Tongue
CL Item
0: None (1)
CL Item
1: Minimal (2)
CL Item
2: Mild (3)
CL Item
3: Moderate (4)
CL Item
4: Severe (5)
Item
Extremity movements: Upper (arms, wrists, hands, fingers)
integer
C3640443 (UMLS CUI [1])
Code List
Extremity movements: Upper (arms, wrists, hands, fingers)
CL Item
0: None (1)
CL Item
1: Minimal (2)
CL Item
2: Mild (3)
CL Item
3: Moderate (4)
CL Item
4: Severe (5)
Item
Extremity movements: Lower (legs, knees, ankles, toes)
integer
C3640444 (UMLS CUI [1])
Code List
Extremity movements: Lower (legs, knees, ankles, toes)
CL Item
0: None (1)
CL Item
1: Minimal (2)
CL Item
2: Mild (3)
CL Item
3: Moderate (4)
CL Item
4: Severe (5)
Item
Trunk movements: Neck, shoulders, hip
integer
C3640445 (UMLS CUI [1])
Code List
Trunk movements: Neck, shoulders, hip
CL Item
0: None (1)
CL Item
1: Minimal (2)
CL Item
2: Mild (3)
CL Item
3: Moderate (4)
CL Item
4: Severe (5)
Item
Global Judgements: Severity of abnormal movements
integer
C3640446 (UMLS CUI [1])
Code List
Global Judgements: Severity of abnormal movements
CL Item
0: None (1)
CL Item
1: Minimal (2)
CL Item
2: Mild (3)
CL Item
3: Moderate (4)
CL Item
4: Severe (5)
Item
Global Judgements: Incapacitation due to abnormal movements
integer
C3640447 (UMLS CUI [1])
Code List
Global Judgements: Incapacitation due to abnormal movements
CL Item
0: None (1)
CL Item
1: Minimal (2)
CL Item
2: Mild (3)
CL Item
3: Moderate (4)
CL Item
4: Severe (5)
Item
Global Judgements: Subject´s awareness of abnormal movements
integer
C3640448 (UMLS CUI [1])
Code List
Global Judgements: Subject´s awareness of abnormal movements
CL Item
0: No awareness (1)
CL Item
1: Awareness, no distress (2)
CL Item
2: Awareness, mild distress (3)
CL Item
3: Awareness, moderate distress (4)
CL Item
4: Awareness, severe distress (5)
Item
Dental Status: Current problems with teeth and/or dentures
integer
C3640449 (UMLS CUI [1])
Code List
Dental Status: Current problems with teeth and/or dentures
CL Item
0: None (1)
CL Item
1: Minimal (2)
CL Item
2: Mild (3)
CL Item
3: Moderate (4)
CL Item
4: Severe (5)
AIMS: Does the subject usually wear dentures?
Item
Dental Status: Does the subject usually wear dentures?
boolean
C3640450 (UMLS CUI [1])
Item Group
Barnes Akathisia Rating Scale
C3541345 (UMLS CUI-1)
Item
Objective
integer
C3640451 (UMLS CUI [1])
Code List
Objective
CL Item
0: Normal, occasional fidgety movements of the limbs (1)
CL Item
1: Presence of characteristic restless movements: shuffling or tramping movements of the legs/feet, or swinging of one leg while sitting, and/or rocking from foot to foot or “walking on the spot” when standing, but movements present for less than half the time observed (2)
CL Item
2: Observed phenomena, as described in (1) above, which are present for at least half the observation period (3)
CL Item
3: Patient is constantly engaged in characteristic restless movements, and/or has the inability to remain seated or standing without walking or pacing, during the time observed (4)
Item
Subjective: Awareness of restlessness
integer
C3640452 (UMLS CUI [1])
Code List
Subjective: Awareness of restlessness
CL Item
0: Absence of inner restlessness (1)
CL Item
1: Non-specific sense of inner restlessness (2)
CL Item
2: The patient is aware of an inability to keep the legs still, or a desire to move the legs, and/or complains of inner restlessness aggravated specifically by being required to stand still (3)
CL Item
3: Awareness of intense compulsion to move most of the time and/or reports strong desire to walk or pace most of the time (4)
Item
Subjective: Reported distress related to restlessness
integer
C3640453 (UMLS CUI [1])
Code List
Subjective: Reported distress related to restlessness
CL Item
0: No distress (1)
CL Item
1: Mild (2)
CL Item
2: Moderate (3)
CL Item
3: Severe (4)
Item
Global clinical rating of akathisia
integer
C3640454 (UMLS CUI [1])
Code List
Global clinical rating of akathisia
CL Item
0: Absent. No evidence of awareness of restlessness. Observation of characteristic movements of akathisia in the absence of a subjective report of inner restlessness or compulsive desire to move the legs should be classified as pseudoakathisia. (1)
CL Item
1: Questionable. Non-specific inner tension and fidgety movements. (2)
CL Item
2: Mild akathisia. Awareness of restlessness in the legs and/or inner restlessness worse when required to stand still. Fidgety movements present, but characteristic restless movements of akathisia not necessarily observed. Condition causes little or no distress. (3)
CL Item
3: Moderate akathisia. Awareness of restlessness as described for mild akathisia above, combined with characteristic restless movements such as rocking from foot to foot when standing. Patient finds the condition distressing. (4)
CL Item
4: Marked akathisia. Subjective experience of restlessness includes a compulsive desire to walk or pace. However, the patient is able to remain seated for at least five minutes. The condition is obviously distressing. (5)
CL Item
5: Severe akathisia. The patient reports a strong compulsion to pace up and down most of the time. Unable to sit or lie down for more than a few minutes. Constant restlessness which is associated with intense distress and insomnia. (6)
Item Group
Simpson Angus Rating Scale
C0030569 (UMLS CUI-1)
C0450973 (UMLS CUI-2)
Item
1 Gait
integer
C0016928 (UMLS CUI [1,1])
C0450973 (UMLS CUI [1,2])
Code List
1 Gait
CL Item
0 Normal (1)
CL Item
1 Diminution in swing while the patient is walking (2)
CL Item
2 Marked diminution in swing with obvious rigidity in the arm (3)
CL Item
3 Stiff gait with arms held rigidly before the abdomen (4)
CL Item
4 Stooped shuffling gait with propulsion and retropulsion (5)
Item
2 Arm Dropping
integer
C0231650 (UMLS CUI [1,1])
C0450973 (UMLS CUI [1,2])
Code List
2 Arm Dropping
CL Item
0 Normal, free fall with loud slap and rebound (1)
CL Item
1 Fall slowed slightly with less audible contact and little rebound (2)
CL Item
2 Fall slowed, no rebound (3)
CL Item
3 Marked slowing, no slap at all (4)
CL Item
4 Arms fall as though against resistance; as though through glue (5)
Item
3 Shoulder shaking
integer
C0037004 (UMLS CUI [1,1])
C1883023 (UMLS CUI [1,2])
C0450973 (UMLS CUI [1,3])
Code List
3 Shoulder shaking
CL Item
0 Normal (1)
CL Item
1 Slight stiffness and resistance (2)
CL Item
2 Moderate stiffness and resistance (3)
CL Item
3 Marked rigidity with difficulty in passive movement (4)
CL Item
4 Extreme stiffness and rigidity with almost a frozen shoulder (5)
Item
4 Elbow rigidity
integer
C0013769 (UMLS CUI [1,1])
C0858572 (UMLS CUI [1,2])
C0450973 (UMLS CUI [1,3])
Code List
4 Elbow rigidity
CL Item
0 Normal (1)
CL Item
1 Slight stiffness and resistance (2)
CL Item
2 Moderate stiffness and resistance (3)
CL Item
3 Marked rigidity with difficulty in passive movement (4)
CL Item
4 Extreme stiffness and rigidity with almost a frozen elbow (5)
Item
5 Wrist rigidity
integer
C0043262 (UMLS CUI [1,1])
C0858572 (UMLS CUI [1,2])
C0450973 (UMLS CUI [1,3])
Code List
5 Wrist rigidity
CL Item
0 Normal (1)
CL Item
1 Slight stiffness and resistance (2)
CL Item
2 Moderate stiffness and resistance (3)
CL Item
3 Marked rigidity with difficulty in passive movement (4)
CL Item
4 Extreme stiffness and rigidity with almost frozen wrist (5)
Item
6 Leg pendulousness
integer
C1140621 (UMLS CUI [1,1])
C4068836 (UMLS CUI [1,2])
C0450973 (UMLS CUI [1,3])
Code List
6 Leg pendulousness
CL Item
0 The legs swing freely (1)
CL Item
1 Slight diminution in the swing of the legs (2)
CL Item
2 Moderate resistance to swing (3)
CL Item
3 Marked resistance and damping of swing (4)
CL Item
4 Complete absence of swing (5)
Item
7 Head dropping
integer
C0018670 (UMLS CUI [1,1])
C1705648 (UMLS CUI [1,2])
C0450973 (UMLS CUI [1,3])
Code List
7 Head dropping
CL Item
0 The head falls completely with a good thump as it hits the table (1)
CL Item
1 Slight slowing in fall, mainly noted by lack of slap as head meets the table (2)
CL Item
2 Moderate slowing in the fall quite noticeable to the eye (3)
CL Item
3 Head falls stiffly and slowly (4)
CL Item
4 Head does not reach the examining table (5)
Item
8 Glabella tap
integer
C0576550 (UMLS CUI [1,1])
C0450973 (UMLS CUI [1,2])
Code List
8 Glabella tap
CL Item
0 0-5 blinks (1)
CL Item
1 6-10 blinks (2)
CL Item
2 11-15 blinks (3)
CL Item
3 16-20 blinks (4)
CL Item
4 21 and more blinks (5)
Item
9 Tremor
integer
C0040822 (UMLS CUI [1,1])
C0450973 (UMLS CUI [1,2])
Code List
9 Tremor
CL Item
0 Normal (1)
CL Item
1 Mild finger tremor, obvious to sight and touch (2)
CL Item
2 Tremor of hand or arm occurring spasmodically (3)
CL Item
3 Persistent tremor of one or more limbs (4)
CL Item
4 Whole body tremor (5)
Item
10 Salivation
integer
C0036104 (UMLS CUI [1,1])
C0450973 (UMLS CUI [1,2])
Code List
10 Salivation
CL Item
0 Normal (1)
CL Item
1 Excess salivation to the extent that pooling takes place if the mouth is open and the tongue raised (2)
CL Item
2 When excess salivation is present and might occasionally result in difficulty speaking (3)
CL Item
3 Speaking with difficulty because of excess salivation (4)
CL Item
4 Frank drooling (5)
Item Group
Columbia - Suicide Severity Rating Scale (C-SSRS) Since Last Visit Version
C3641328 (UMLS CUI-1)
SSRS: Wish to be dead
Item
Suicidal Ideation: Wish to be dead
boolean
C3641578 (UMLS CUI [1])
SSRS: Description of wish to be dead
Item
Suicidal Ideation: If ´Yes´, describe:
text
C3641579 (UMLS CUI [1])
SSRS: Non-specific active suicidal thoughts
Item
Suicidal Ideation: Non-specific active suicidal thoughts
boolean
C3641580 (UMLS CUI [1])
SSRS: Description of Non-Specific Active Suicidal Thoughts
Item
Suicidal Ideation: If ´Yes´, describe:
text
C3641581 (UMLS CUI [1])
SSRS: Active suicidal ideation with any methods (not plan) without intent to act
Item
Suicidal Ideation: Active suicidal ideation with any methods (not plan) without intent to act
boolean
C3641582 (UMLS CUI [1])
SSRS: Description of Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act
Item
Suicidal Ideation: If ´Yes´, describe:
text
C3641583 (UMLS CUI [1])
SSRS: Active suicidal ideation with some intent to act, without specific plan
Item
Suicidal Ideation: Active suicidal ideation with some intent to act, without specific plan
boolean
C3641605 (UMLS CUI [1])
SSRS: Description of Active Suicidal Ideation with Some Intent to Act, without Specific Plan
Item
Suicidal Ideation: If ´Yes´, describe:
text
C3641606 (UMLS CUI [1])
SSRS: Active suicidal ideation with specific plan and intent
Item
Suicidal Ideation: Active suicidal ideation with specific plan and intent
boolean
C3641607 (UMLS CUI [1])
SSRS: Description of Active Suicidal Ideation with Specific Plan and Intent
Item
Suicidal Ideation: If ´Yes´, describe:
text
C3641584 (UMLS CUI [1])
Item
Intensity of Ideation: Most Severe Ideation
integer
C3641585 (UMLS CUI [1])
Code List
Intensity of Ideation: Most Severe Ideation
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
SSRS: Description of Ideation
Item
Intensity of Ideation: Description of Most Severe Ideation
text
C3641586 (UMLS CUI [1])
Item
Intensity of Ideation: Frequency of Most Severe Ideation
integer
C3641587 (UMLS CUI [1])
Code List
Intensity of Ideation: Frequency of Most Severe Ideation
CL Item
1 Less than once a week  (1)
CL Item
2 Once a week  (2)
CL Item
3 2-5 times in week  (3)
CL Item
4 Daily or almost daily  (4)
CL Item
5 Many times each day (5)
Item
Intensity of Ideation: Duration of Most Severe Ideation
integer
C3641588 (UMLS CUI [1])
Code List
Intensity of Ideation: Duration of Most Severe Ideation
CL Item
1 Fleeting - few seconds or minutes (1)
CL Item
2 Less than 1 hour/some of the time (2)
CL Item
3 1-4 hours/a lot of time (3)
CL Item
4 4-8 hours/most of day (4)
CL Item
5 More than 8 hours/persistent or continuous (5)
Item
Intensity of Ideation: Controllability of Most Severe Ideation
integer
C3641589 (UMLS CUI [1])
Code List
Intensity of Ideation: Controllability of Most Severe Ideation
CL Item
1 Easily able to control thoughts (1)
CL Item
2 Can control thoughts with little difficulty (2)
CL Item
3 Can control thoughts with some difficulty  (3)
CL Item
4 Can control thoughts with a lot of difficulty (4)
CL Item
5 Unable to control thoughts (5)
CL Item
0 Does not attempt to control thoughts (6)
Item
Intensity of Ideation: Deterrents to Most Severe Ideation
integer
C3641590 (UMLS CUI [1])
Code List
Intensity of Ideation: Deterrents to Most Severe Ideation
CL Item
1 Deterrents definitely stopped you from attempting suicide (1)
CL Item
2 Deterrents probably stopped you (2)
CL Item
3 Uncertain that deterrents stopped you  (3)
CL Item
4 Deterrents most likely did not stop you  (4)
CL Item
5 Deterrents definitely did not stop you  (5)
CL Item
0 Does not apply (6)
Item
Intensity of Ideation: Reasons for Most Severe Ideation
integer
C3641591 (UMLS CUI [1])
Code List
Intensity of Ideation: Reasons for Most Severe Ideation
CL Item
1 Completely to get attention, revenge or a reaction from others (1)
CL Item
2 Mostly to get attention, revenge or a reaction from others (2)
CL Item
3 Equally to get attention, revenge or a reaction from others and to end/stop the pain (3)
CL Item
4 Mostly to end or stop the pain (you couldn’t go on living with the pain or how you were feeling) (4)
CL Item
5 Completely to end or stop the pain (you couldn’t go on living with the pain or how you were feeling) (5)
CL Item
0 Does not apply (6)
SSRS: Actual Suicide Attempt
Item
Suicidal Behavior: Actual attempt
boolean
C3641592 (UMLS CUI [1])
SSRS: Number of Actual Suicide Attempts
Item
Suicidal Behavior: If ´Yes´, specify total number of attempts:
integer
C3641593 (UMLS CUI [1])
SSRS: Description of Actual Suicide Attempts
Item
Suicidal Behavior: If ´Yes´, describe:
text
C3641594 (UMLS CUI [1])
SSRS: Non-suicidal self-injurious behavior
Item
Suicidal Behavior: Non-suicidal self-injurious behavior
boolean
C3641595 (UMLS CUI [1])
SSRS: Interrupted Suicide Attempt
Item
Suicidal Behavior: Interrupted attempt
boolean
C3641596 (UMLS CUI [1])
SSRS: Number of Interrupted Suicide Attempts
Item
Suicidal Behavior: If ´Yes´, specify total number of interrupted attempts:
integer
C3641597 (UMLS CUI [1])
SSRS: Description of Interrupted Suicide Attempts
Item
Suicidal Behavior: If ´Yes´, describe:
text
C3641598 (UMLS CUI [1])
SSRS: Aborted Suicide Attempt
Item
Suicidal Behavior: Aborted attempt
boolean
C3641599 (UMLS CUI [1])
SSRS: Number of Aborted Suicide Attempts
Item
Suicidal Behavior: If ´Yes´, specify total number of aborted attempts:
integer
C3641600 (UMLS CUI [1])
SSRS: Description of Aborted Suicide Attempt
Item
Suicidal Behavior: If ´Yes´, describe:
text
C3641601 (UMLS CUI [1])
SSRS: Preparatory Acts or Behaviors Toward Suicide Attempt
Item
Suicidal Behavior: Preparatory acts or behavior toward suicide attempt
boolean
C3641602 (UMLS CUI [1])
SSRS: Description of Preparatory Acts or Behaviors Toward Suicide Attempt
Item
Suicidal Behavior: If ´Yes´, describe:
text
C3641603 (UMLS CUI [1])
SSRS: Suicidal Behavior
Item
Suicidal Behavior
boolean
C3641604 (UMLS CUI [1])
SSRS: Completed suicide
Item
Completed suicide
boolean
C3641338 (UMLS CUI [1])
SSRS: Most Lethal Suicide Attempt Date
Item
Suicidal Behavior - Actual Attempts: Most lethal attempt date
date
C3641339 (UMLS CUI [1])
Item
Suicidal Behavior - Actual Attempts: Most Lethal Suicide Attempt actual lethality/medical damage
integer
C3641340 (UMLS CUI [1])
Code List
Suicidal Behavior - Actual Attempts: Most Lethal Suicide Attempt actual lethality/medical damage
CL Item
0 No physical damage or very minor physical damage (e.g., surface scratches). (1)
CL Item
1 Minor physical damage (e.g., lethargic speech; first-degree burns; mild bleeding; sprains). (2)
CL Item
2 Moderate physical damage; medical attention needed (e.g., conscious but sleepy, somewhat responsive; second-degree burns; bleeding of major vessel). (3)
CL Item
3 Moderately severe physical damage; medical hospitalization and likely intensive care required (e.g., comatose with reflexes intact; third-degree burns less than 20% of body; extensive blood loss but can recover; major fractures). (4)
CL Item
4 Severe physical damage; medical hospitalization with intensive care required (e.g., comatose without reflexes; third-degree burns over 20% of body; extensive blood loss with unstable vital signs; major damage to a vital area). (5)
CL Item
5 Death (6)
Item
Suicidal Behavior - Actual Attempts: Most Lethal Suicide Attempt potential lethality
integer
C3641341 (UMLS CUI [1])
Code List
Suicidal Behavior - Actual Attempts: Most Lethal Suicide Attempt potential lethality
CL Item
0 Behavior not likely to result in injury (1)
CL Item
1 Behavior likely to result in injury but not likely to cause death (2)
CL Item
2 Behavior likely to result in death despite available medical care (3)
Item Group
Investigator Evaluation of lnjection site
C0035173 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
C2700396 (UMLS CUI-3)
Rater's initials
Item
Rater's initials
text
C3166278 (UMLS CUI [1])
Time of evaluation
Item
Time of evaluation
time
C0040223 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Item
Redness
integer
C0332575 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Code List
Redness
CL Item
Absent (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Item
Swelling
integer
C0038999 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Code List
Swelling
CL Item
Absent (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Item
Induration
integer
C0332534 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Code List
Induration
CL Item
Absent (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Item Group
Subject Evaluation of lnjection site
C0030705 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
C2700396 (UMLS CUI-3)
Time of evaluation
Item
Time of evaluation
time
C0040223 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Injection pain
Item
Injection pain
boolean
C0151828 (UMLS CUI [1])
Item Group
Positive and Negative Syndrome Scale for Schizophrenia
C4086747 (UMLS CUI-1)
C0036341 (UMLS CUI-2)
Rater's initials
Item
Rater's initials
text
C3166278 (UMLS CUI [1])
Item
Positive subscale: P01 Delusions
integer
C4087066 (UMLS CUI [1])
Code List
Positive subscale: P01 Delusions
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
Positive subscale: P02 Conceptual disorganization
integer
C4086687 (UMLS CUI [1])
Code List
Positive subscale: P02 Conceptual disorganization
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
Positive subscale: P03 Hallucinatory behavior
integer
C4086696 (UMLS CUI [1])
Code List
Positive subscale: P03 Hallucinatory behavior
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
Positive subscale: P04 Excitement
integer
C4086693 (UMLS CUI [1])
Code List
Positive subscale: P04 Excitement
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
Positive subscale: P05 Grandiosity
integer
C4086694 (UMLS CUI [1])
Code List
Positive subscale: P05 Grandiosity
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
Positive subscale: P06 Suspiciousness/persecution
integer
C4087067 (UMLS CUI [1])
Code List
Positive subscale: P06 Suspiciousness/persecution
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
Positive subscale: P07 Hostility
integer
C4086697 (UMLS CUI [1])
Code List
Positive subscale: P07 Hostility
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
Negative subscale: N01 Blunted affect
integer
C4086686 (UMLS CUI [1])
Code List
Negative subscale: N01 Blunted affect
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
Negative subscale: N02 Emotional withdrawal
integer
C4086692 (UMLS CUI [1])
Code List
Negative subscale: N02 Emotional withdrawal
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
Negative subscale: N03 Poor rapport
integer
C4086705 (UMLS CUI [1])
Code List
Negative subscale: N03 Poor rapport
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
Negative subscale: N04 Passive/apathetic social withdrawal
integer
C4086702 (UMLS CUI [1])
Code List
Negative subscale: N04 Passive/apathetic social withdrawal
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
Negative subscale: N05 Difficulty in abstract thinking
integer
C4086689 (UMLS CUI [1])
Code List
Negative subscale: N05 Difficulty in abstract thinking
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
Negative subscale: N06 Lack of spontaneity and flow of conversation
integer
C4086699 (UMLS CUI [1])
Code List
Negative subscale: N06 Lack of spontaneity and flow of conversation
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
Negative subscale: N07 Stereotyped thinking
integer
C4086708 (UMLS CUI [1])
Code List
Negative subscale: N07 Stereotyped thinking
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
General psychopathology subscale: G01 Somatic concern
integer
C4086707 (UMLS CUI [1])
Code List
General psychopathology subscale: G01 Somatic concern
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
General psychopathology subscale: G02 Anxiety
integer
C4086685 (UMLS CUI [1])
Code List
General psychopathology subscale: G02 Anxiety
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
General psychopathology subscale: G03 Guilt feelings
integer
C4086695 (UMLS CUI [1])
Code List
General psychopathology subscale: G03 Guilt feelings
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
General psychopathology subscale: G04 Tension
integer
C4086709 (UMLS CUI [1])
Code List
General psychopathology subscale: G04 Tension
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
General psychopathology subscale: G05 Mannerisms and posturing
integer
C4086700 (UMLS CUI [1])
Code List
General psychopathology subscale: G05 Mannerisms and posturing
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
General psychopathology subscale: G06 Depression
integer
C4086688 (UMLS CUI [1])
Code List
General psychopathology subscale: G06 Depression
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
General psychopathology subscale: G07 Motor retardation
integer
C4086701 (UMLS CUI [1])
Code List
General psychopathology subscale: G07 Motor retardation
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
General psychopathology subscale: G08 Uncooperativeness
integer
C4086710 (UMLS CUI [1])
Code List
General psychopathology subscale: G08 Uncooperativeness
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
General psychopathology subscale: G09 Unusual thought content
integer
C4086711 (UMLS CUI [1])
Code List
General psychopathology subscale: G09 Unusual thought content
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
General psychopathology subscale: G10 Disorientation
integer
C4086690 (UMLS CUI [1])
Code List
General psychopathology subscale: G10 Disorientation
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
General psychopathology subscale: G11 Poor attention
integer
C4086703 (UMLS CUI [1])
Code List
General psychopathology subscale: G11 Poor attention
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
General psychopathology subscale: G12 Lack of judgment and insight
integer
C4086698 (UMLS CUI [1])
Code List
General psychopathology subscale: G12 Lack of judgment and insight
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
General psychopathology subscale: G13 Disturbance of volition
integer
C4086691 (UMLS CUI [1])
Code List
General psychopathology subscale: G13 Disturbance of volition
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
General psychopathology subscale: G14 Poor impulse control
integer
C4086704 (UMLS CUI [1])
Code List
General psychopathology subscale: G14 Poor impulse control
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
General psychopathology subscale: G15 Preoccupation
integer
C4086706 (UMLS CUI [1])
Code List
General psychopathology subscale: G15 Preoccupation
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
General psychopathology subscale: G16 Active social avoidence
integer
C4086684 (UMLS CUI [1])
Code List
General psychopathology subscale: G16 Active social avoidence
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Calculated total PANSS score
Item
Calculated total PANSS score
integer
C4086747 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
Item Group
Mini Positive and Negative Syndrome Scale for Schizophrenia
C1282927 (UMLS CUI-1)
C4086747 (UMLS CUI-2)
C0036341 (UMLS CUI-3)
Rater's initials
Item
Rater's initials
text
C3166278 (UMLS CUI [1])
Item
Positive subscale: P01 Delusions
integer
C4087066 (UMLS CUI [1])
Code List
Positive subscale: P01 Delusions
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
Positive subscale: P02 Conceptual disorganization
integer
C4086687 (UMLS CUI [1])
Code List
Positive subscale: P02 Conceptual disorganization
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
Positive subscale: P03 Hallucinatory behavior
integer
C4086696 (UMLS CUI [1])
Code List
Positive subscale: P03 Hallucinatory behavior
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
Positive subscale: P06 Suspiciousness/persecution
integer
C4087067 (UMLS CUI [1])
Code List
Positive subscale: P06 Suspiciousness/persecution
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
Positive subscale: P07 Hostility
integer
C4086697 (UMLS CUI [1])
Code List
Positive subscale: P07 Hostility
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
General psychopathology subscale: G08 Uncooperativeness
integer
C4086710 (UMLS CUI [1])
Code List
General psychopathology subscale: G08 Uncooperativeness
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item Group
Clinical Global Impression - Severity
C3639708 (UMLS CUI-1)
Rater´s initials
Item
Rater´s initials
text
C3166278 (UMLS CUI [1])
Item
Considering your total clinical experience with this particular population, how severe is the subject's psychotic disorder at this time?
integer
C3698629 (UMLS CUI [1])
Code List
Considering your total clinical experience with this particular population, how severe is the subject's psychotic disorder at this time?
CL Item
normal, not at all ill (1)
CL Item
borderline mentally ill (2)
CL Item
mildly ill (3)
CL Item
moderately ill (4)
CL Item
markedly ill (5)
CL Item
severely ill (6)
CL Item
among the most extremely ill patients (7)
Item Group
Personal and Social Performance Scale
C0450973 (UMLS CUI-1)
C0037397 (UMLS CUI-2)
Rater's initials
Item
Rater's initials
text
C3166278 (UMLS CUI [1])
Item
Domain of functioning: Socially useful activities, including work and study
integer
C3641834 (UMLS CUI [1])
Code List
Domain of functioning: Socially useful activities, including work and study
CL Item
1 Absent (1)
CL Item
2 Mild (2)
CL Item
3 Manifest (3)
CL Item
4 Marked (4)
CL Item
5 Severe (5)
CL Item
6 Very Severe (6)
Item
Domain of functioning: Personal and social relationships
integer
C0021797 (UMLS CUI [1])
Code List
Domain of functioning: Personal and social relationships
CL Item
1 Absent (1)
CL Item
2 Mild (2)
CL Item
3 Manifest (3)
CL Item
4 Marked (4)
CL Item
5 Severe (5)
CL Item
6 Very Severe (6)
Item
Domain of functioning: Self-care
integer
C0474417 (UMLS CUI [1])
Code List
Domain of functioning: Self-care
CL Item
1 Absent (1)
CL Item
2 Mild (2)
CL Item
3 Manifest (3)
CL Item
4 Marked (4)
CL Item
5 Severe (5)
CL Item
6 Very Severe (6)
Item
Domain of functioning: Disturbing and aggressive behaviors
integer
C0001807 (UMLS CUI [1])
Code List
Domain of functioning: Disturbing and aggressive behaviors
CL Item
1 Absent (1)
CL Item
2 Mild (2)
CL Item
3 Manifest (3)
CL Item
4 Marked (4)
CL Item
5 Severe (5)
CL Item
6 Very Severe (6)
Total score
Item
Total score
integer
C2964552 (UMLS CUI [1])
Item Group
Evaluation of relapse
C0220825 (UMLS CUI-1)
C0035020 (UMLS CUI-2)
Psychiatric hospitalization
Item
1.Since the last visit, has the subject had a psychiatric hospitalization (involuntary or voluntary admission to a psychiatric hospital for decompensation of the subject´s schizophrenic symptoms)
boolean
C0748061 (UMLS CUI [1])
Psychiatric hospitalization date
Item
If `yes`, please enter date of psychiatric hospitalization:
date
C0748061 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Worsening of schizophrenic symptoms, PANSS
Item
2.Worsening: A. An increase of >= 25% in total PANSS score from randomization if the score at randomization was >40.
boolean
C0036341 (UMLS CUI [1,1])
C1546960 (UMLS CUI [1,2])
C4086747 (UMLS CUI [1,3])
Date, worsening of schizophrenic symptoms
Item
If `yes`, please enter date:
date
C0011008 (UMLS CUI [1,1])
C0036341 (UMLS CUI [1,2])
C1546960 (UMLS CUI [1,3])
Worsening of schizophrenic symptoms, PANSS
Item
2.Worsening: B. A 10 point increase in total PANSS score from randomization if the score at randomization was <= 40
boolean
C0036341 (UMLS CUI [1,1])
C1546960 (UMLS CUI [1,2])
C4086747 (UMLS CUI [1,3])
Date, worsening of schizophrenic symptoms
Item
If `yes`, please enter date:
date
C0011008 (UMLS CUI [1,1])
C0036341 (UMLS CUI [1,2])
C1546960 (UMLS CUI [1,3])
Self-injury, physical aggression
Item
3.Since the last visit, has the subject had a deliberate self-injury or exhibited violent behavior resulting in suicide, clinically significant injury to him/her self or another person or significant property damage?
boolean
C0178360 (UMLS CUI [1,1])
C0424323 (UMLS CUI [1,2])
Date of self-injury or physical aggression
Item
If `yes`, please enter date of event:
date
C0011008 (UMLS CUI [1,1])
C0178360 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0424323 (UMLS CUI [1,4])
Item
If `yes`, describe the event:
integer
C2348235 (UMLS CUI [1,1])
C0178360 (UMLS CUI [1,2])
C0424323 (UMLS CUI [1,3])
Code List
If `yes`, describe the event:
CL Item
Deliberate self-injury  (1)
CL Item
Violent behavior resulting in suicide, injury or property damage (2)
Suicidal or homicidal ideation, aggressive behavior
Item
4.Since the last visit, has the subject had a suicidal or homicidal ideation and aggressive behavior that was clinically significant (in frequency and severity) in the investigator´s judgment?
boolean
C0749133 (UMLS CUI [1,1])
C0455204 (UMLS CUI [1,2])
C0001807 (UMLS CUI [1,3])
Date of suicidal or homicidal ideation, aggressive behavior
Item
If `yes`, please enter date of event:
date
C0011008 (UMLS CUI [1,1])
C0749133 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0455204 (UMLS CUI [1,4])
C0011008 (UMLS CUI [1,5])
C0001807 (UMLS CUI [1,6])
Item
If `yes`, describe the event:
integer
C2348235 (UMLS CUI [1,1])
C0749133 (UMLS CUI [1,2])
C0455204 (UMLS CUI [1,3])
C0001807 (UMLS CUI [1,4])
CL Item
Suicide attempt  (1)
CL Item
Suicidal ideation  (2)
CL Item
Homicidal ideation (3)
Worsening of schizophrenic symptoms, PANSS
Item
5.Worsening of any one of the following PANSS items: P1 (delusions), P2 (conceptual disorganization), P3 (hallucinatory behavior), P6 (suspiciousness/persecution), P7 (hostility) or G8 (uncooperativeness) to: A. A score of >= 5 after randomization on any of the above PANSS items if the maximum score for the above PANSS items was <= 3 at randomization
boolean
C0036341 (UMLS CUI [1,1])
C1546960 (UMLS CUI [1,2])
C4086747 (UMLS CUI [1,3])
Date, worsening of schizophrenic symptoms
Item
If `yes`, please enter date:
date
C0011008 (UMLS CUI [1,1])
C0036341 (UMLS CUI [1,2])
C1546960 (UMLS CUI [1,3])
Worsening of schizophrenic symptoms, PANSS
Item
5.Worsening of any one of the following PANSS items: P1 (delusions), P2 (conceptual disorganization), P3 (hallucinatory behavior), P6 (suspiciousness/persecution), P7 (hostility) or G8 (uncooperativeness) to: B. A score of >= 6 after randomization on any of the above PANSS items if the maximum score for the above PANSS items was = 4 at randomization
boolean
C0036341 (UMLS CUI [1,1])
C1546960 (UMLS CUI [1,2])
C4086747 (UMLS CUI [1,3])
Date, worsening of schizophrenic symptoms
Item
If `yes`, please enter date:
date
C0011008 (UMLS CUI [1,1])
C0036341 (UMLS CUI [1,2])
C1546960 (UMLS CUI [1,3])
Item Group
Unscheduled Forms: Please select assessments performed at this unscheduled visit
C3854240 (UMLS CUI-1)
C0376315 (UMLS CUI-2)
PK Blood Sample
Item
PK Blood Sample
boolean
C0201734 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
Positive and Negative Syndrome Scale for Schizophrenia
Item
Positive and Negative Syndrome Scale for Schizophrenia
boolean
C4086747 (UMLS CUI [1,1])
C0036341 (UMLS CUI [1,2])
Simpson Angus Rating Scale
Item
Simpson Angus Rating Scale
boolean
C0030569 (UMLS CUI [1,1])
C0450973 (UMLS CUI [1,2])
Abnormal Involuntary Movement Scale
Item
Abnormal Involuntary Movement Scale
boolean
C0450978 (UMLS CUI [1])
Barnes Akathisia Rating Scale
Item
Barnes Akathisia Rating Scale
boolean
C3541345 (UMLS CUI [1])
Personal and Social Performance Scale
Item
Personal and Social Performance Scale
boolean
C0450973 (UMLS CUI [1,1])
C0037397 (UMLS CUI [1,2])
Evaluation of Relapse
Item
Evaluation of Relapse
boolean
C0220825 (UMLS CUI [1,1])
C0035020 (UMLS CUI [1,2])
Vital Signs with Weight, Waist and Temperature
Item
Vital Signs with Weight, Waist and Temperature
boolean
C0518766 (UMLS CUI [1])
Urine Dipstick Pregnancy Test
Item
Urine Dipstick Pregnancy Test
boolean
C0430056 (UMLS CUI [1])
Clinical Global Impression - Severity
Item
Clinical Global Impression - Severity
boolean
C3639708 (UMLS CUI [1])
Mini Positive and Negative Syndrome Scale for Schizophrenia
Item
Mini-Positive and Negative Syndrome Scale for Schizophrenia
boolean
C1282927 (UMLS CUI [1,1])
C4086747 (UMLS CUI [1,2])
C0036341 (UMLS CUI [1,3])
Columbia - Suicide Severity Rating Scale (C-SSRS) Since Last Visit
Item
Columbia - Suicide Severity Rating Scale (C-SSRS) Since Last Visit
boolean
C3641328 (UMLS CUI [1])
Investigator Evaluation of Injection site
Item
Investigator Evaluation of Injection site
boolean
C0035173 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Subject Evaluation of Injection site
Item
Subject Evaluation of Injection site
boolean
C0030705 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Lab Sample Central Lab
Item
Lab Sample Central Lab
boolean
C3244292 (UMLS CUI [1])
ECG
Item
ECG
boolean
C1623258 (UMLS CUI [1])

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