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
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])
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: 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
General psychopathology subscale: G08 Uncooperativeness
integer
C4086710 (UMLS CUI [1])
Code List
General psychopathology subscale: G08 Uncooperativeness
CL Item
5: Moderate severe (5)
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])