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
5: Moderate severe (5)
Item
Positive subscale: P02 Conceptual disorganization
integer
C4086687 (UMLS CUI [1])
Code List
Positive subscale: P02 Conceptual disorganization
CL Item
5: Moderate severe (5)
Item
Positive subscale: P03 Hallucinatory behavior
integer
C4086696 (UMLS CUI [1])
Code List
Positive subscale: P03 Hallucinatory behavior
CL Item
5: Moderate severe (5)
Item
Positive subscale: P04 Excitement
integer
C4086693 (UMLS CUI [1])
Code List
Positive subscale: P04 Excitement
CL Item
5: Moderate severe (5)
Item
Positive subscale: P05 Grandiosity
integer
C4086694 (UMLS CUI [1])
Code List
Positive subscale: P05 Grandiosity
CL Item
5: Moderate severe (5)
Item
Positive subscale: P06 Suspiciousness/persecution
integer
C4087067 (UMLS CUI [1])
Code List
Positive subscale: P06 Suspiciousness/persecution
CL Item
5: Moderate severe (5)
Item
Positive subscale: P07 Hostility
integer
C4086697 (UMLS CUI [1])
Code List
Positive subscale: P07 Hostility
CL Item
5: Moderate severe (5)
Item
Negative subscale: N01 Blunted affect
integer
C4086686 (UMLS CUI [1])
Code List
Negative subscale: N01 Blunted affect
CL Item
5: Moderate severe (5)
Item
Negative subscale: N02 Emotional withdrawal
integer
C4086692 (UMLS CUI [1])
Code List
Negative subscale: N02 Emotional withdrawal
CL Item
5: Moderate severe (5)
Item
Negative subscale: N03 Poor rapport
integer
C4086705 (UMLS CUI [1])
Code List
Negative subscale: N03 Poor rapport
CL Item
5: Moderate severe (5)
Item
Negative subscale: N04 Passive/apathetic social withdrawal
integer
C4086702 (UMLS CUI [1])
Code List
Negative subscale: N04 Passive/apathetic social withdrawal
CL Item
5: Moderate severe (5)
Item
Negative subscale: N05 Difficulty in abstract thinking
integer
C4086689 (UMLS CUI [1])
Code List
Negative subscale: N05 Difficulty in abstract thinking
CL Item
5: Moderate severe (5)
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
5: Moderate severe (5)
Item
Negative subscale: N07 Stereotyped thinking
integer
C4086708 (UMLS CUI [1])
Code List
Negative subscale: N07 Stereotyped thinking
CL Item
5: Moderate severe (5)
Item
General psychopathology subscale: G01 Somatic concern
integer
C4086707 (UMLS CUI [1])
Code List
General psychopathology subscale: G01 Somatic concern
CL Item
5: Moderate severe (5)
Item
General psychopathology subscale: G02 Anxiety
integer
C4086685 (UMLS CUI [1])
Code List
General psychopathology subscale: G02 Anxiety
CL Item
5: Moderate severe (5)
Item
General psychopathology subscale: G03 Guilt feelings
integer
C4086695 (UMLS CUI [1])
Code List
General psychopathology subscale: G03 Guilt feelings
CL Item
5: Moderate severe (5)
Item
General psychopathology subscale: G04 Tension
integer
C4086709 (UMLS CUI [1])
Code List
General psychopathology subscale: G04 Tension
CL Item
5: Moderate severe (5)
Item
General psychopathology subscale: G05 Mannerisms and posturing
integer
C4086700 (UMLS CUI [1])
Code List
General psychopathology subscale: G05 Mannerisms and posturing
CL Item
5: Moderate severe (5)
Item
General psychopathology subscale: G06 Depression
integer
C4086688 (UMLS CUI [1])
Code List
General psychopathology subscale: G06 Depression
CL Item
5: Moderate severe (5)
Item
General psychopathology subscale: G07 Motor retardation
integer
C4086701 (UMLS CUI [1])
Code List
General psychopathology subscale: G07 Motor retardation
CL Item
5: Moderate severe (5)
Item
General psychopathology subscale: G08 Uncooperativeness
integer
C4086710 (UMLS CUI [1])
Code List
General psychopathology subscale: G08 Uncooperativeness
CL Item
5: Moderate severe (5)
Item
General psychopathology subscale: G09 Unusual thought content
integer
C4086711 (UMLS CUI [1])
Code List
General psychopathology subscale: G09 Unusual thought content
CL Item
5: Moderate severe (5)
Item
General psychopathology subscale: G10 Disorientation
integer
C4086690 (UMLS CUI [1])
Code List
General psychopathology subscale: G10 Disorientation
CL Item
5: Moderate severe (5)
Item
General psychopathology subscale: G11 Poor attention
integer
C4086703 (UMLS CUI [1])
Code List
General psychopathology subscale: G11 Poor attention
CL Item
5: Moderate severe (5)
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
5: Moderate severe (5)
Item
General psychopathology subscale: G13 Disturbance of volition
integer
C4086691 (UMLS CUI [1])
Code List
General psychopathology subscale: G13 Disturbance of volition
CL Item
5: Moderate severe (5)
Item
General psychopathology subscale: G14 Poor impulse control
integer
C4086704 (UMLS CUI [1])
Code List
General psychopathology subscale: G14 Poor impulse control
CL Item
5: Moderate severe (5)
Item
General psychopathology subscale: G15 Preoccupation
integer
C4086706 (UMLS CUI [1])
Code List
General psychopathology subscale: G15 Preoccupation
CL Item
5: Moderate severe (5)
Item
General psychopathology subscale: G16 Active social avoidence
integer
C4086684 (UMLS CUI [1])
Code List
General psychopathology subscale: G16 Active social avoidence
CL Item
5: Moderate severe (5)
Calculated total PANSS score
Item
Calculated total PANSS score
integer
C4086747 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
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])
Code List
If `yes`, describe the event:
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])