Informationen:
Fehler:
ID
22039
Beschreibung
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
Stichworte
Versionen (1)
- 16.05.17 16.05.17 -
Hochgeladen am
16. Mai 2017
DOI
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Lizenz
Creative Commons BY 4.0
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Screening - CRFs Paliperidone Palmitate Schizophrenia NCT01515423
Screening - CRFs Paliperidone Palmitate Schizophrenia NCT01515423
Ähnliche Modelle
Screening - CRFs Paliperidone Palmitate Schizophrenia NCT01515423
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Visit date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Date of informed consent
Item
Date of informed consent
date
C0011008 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,2])
Item
Which protocol version did the subject first consent to?
integer
C2985700 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,2])
Code List
Which protocol version did the subject first consent to?
CL Item
INT-1 (1)
CL Item
INT-2 or INT-2_AUT-1 (2)
CL Item
INT-3 or INT-3_AUT-1 (3)
CL Item
Other (4)
Protocol version, informed consent, specification
Item
If other, specify:
text
C2985700 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0021430 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Re-consent, date in time
Item
In case of re-consent, re-consent date:
date
C0205436 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0021430 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Re-consent protocol version:
integer
C0205436 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C2985700 (UMLS CUI [1,3])
C0021430 (UMLS CUI [1,2])
C2985700 (UMLS CUI [1,3])
CL Item
INT-1 (1)
CL Item
INT-2 or INT-2_AUT-1 (2)
CL Item
INT-3 or INT-3_AUT-1 (3)
CL Item
Other (4)
Re-consent protocol version specification
Item
If other, specify:
text
C0205436 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C2985700 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0021430 (UMLS CUI [1,2])
C2985700 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
In case actual date of birth is not uploaded by IWRS, indicate which part of the date was not recorded:
integer
C0439673 (UMLS CUI [1,1])
C0421451 (UMLS CUI [1,2])
C0421451 (UMLS CUI [1,2])
Code List
In case actual date of birth is not uploaded by IWRS, indicate which part of the date was not recorded:
CL Item
Day of birth unknown (1)
CL Item
Day and Month of birth unknown (2)
Age in years at time of informed consent
Item
Age in years at time of informed consent:
integer
C0001779 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,2])
CL Item
Male (1)
CL Item
Female (2)
CL Item
Unknown (3)
CL Item
Undifferentiated (4)
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
CL Item
Unknown (3)
CL Item
Not reported (4)
CL Item
White (1)
CL Item
Black or African American (2)
CL Item
Asian (3)
CL Item
American Indian or Alaska Native (4)
CL Item
Native Hawaiian or other Pacific Islander (5)
CL Item
Other (6)
CL Item
Unknown (7)
CL Item
Not reported (8)
Race specification
Item
If race is 'Other,' specify:
text
C0034510 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
CL Item
Chinese (Han) (1)
CL Item
Chinese (Other) (2)
CL Item
Korean (3)
CL Item
Japanese (4)
CL Item
Filipino (5)
CL Item
Indian (6)
CL Item
Thai (7)
CL Item
Malay (8)
Chinese people, specification
Item
If 'Chinese (Other)', specify:
text
C0152035 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
eligibility criteria
Item
Has the subject failed to satisfy any protocol eligibility criteria?
boolean
C1516637 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,2])
exclusion criteria
Item
lf 'Yes,' please enter criteria not satisfied below:
text
C0680251 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
CL Item
INCLUSION (1)
CL Item
EXCLUSION (2)
Criteria number
Item
Criteria number
integer
C0243161 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
C1300638 (UMLS CUI [1,2])
Item
Type of Schizophrenia
integer
C0036341 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,2])
CL Item
Paranoid (295.30) (1)
CL Item
Disorganized (295.10) (2)
CL Item
Catatonic (295.20) (3)
CL Item
Undifferentiated (295.90) (4)
CL Item
Residual (295.60) (5)
Age, first diagnosis, schizophrenia
Item
Age at 1st diagnosis of Schizophrenia (yrs)
integer
C0001779 (UMLS CUI [1,1])
C2316983 (UMLS CUI [1,2])
C0036341 (UMLS CUI [1,3])
C2316983 (UMLS CUI [1,2])
C0036341 (UMLS CUI [1,3])
Date of current exacerbation
Item
Date of current exacerbation
date
C0011008 (UMLS CUI [1,1])
C0270383 (UMLS CUI [1,2])
C0270383 (UMLS CUI [1,2])
CL Item
Episodic with interepisode residual symptoms (1)
CL Item
Episodic with no interepisode residual symptoms (2)
CL Item
Continuous (3)
CL Item
Other or unspecified pattern (4)
CL Item
Not known/not applicable (5)
Abnormalities
Item
Were any abnormalities reported?
boolean
C1704258 (UMLS CUI [1])
CL Item
Eyes, ears, nose & throat (1)
CL Item
Respiratory (2)
CL Item
Cardiovascularo (3)
CL Item
Gastrointestinal (4)
CL Item
Genitourinary (5)
CL Item
Musculoskeletal (6)
CL Item
Neurologic (7)
CL Item
Endocrine & metabolic (8)
CL Item
Hematopoietic/lymphatic (9)
CL Item
Dermatologic (10)
CL Item
Psychiatric (11)
CL Item
Allergic/immunologic (12)
CL Item
Reproductive/breast (13)
Abnormality specification
Item
Abnormality
text
C1704258 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
Abnormality ongoing at study entry
Item
Abnormality ongoing at study entry
boolean
C1704258 (UMLS CUI [1,1])
C0580798 (UMLS CUI [1,2])
C0580798 (UMLS CUI [1,2])
Psychosis, hospitalization
Item
Has the subject ever been hospitalized for treatment of psychosis?
boolean
C0033975 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
C0019993 (UMLS CUI [1,2])
Quantity, psychosis, hospitalization
Item
If 'Yes', enter number of prior hospitalizations within the last 24 months:
integer
C1265611 (UMLS CUI [1,1])
C0033975 (UMLS CUI [1,2])
C0019993 (UMLS CUI [1,3])
C0033975 (UMLS CUI [1,2])
C0019993 (UMLS CUI [1,3])
start date, hospitalization
Item
If 'Yes', enter start dates (from) of last four hospitalizations for treatment of psychosis (excluding current) below:
date
C0808070 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
C0033975 (UMLS CUI [1,3])
C0019993 (UMLS CUI [1,2])
C0033975 (UMLS CUI [1,3])
end date, hospitalization
Item
If 'Yes', enter end dates (to) of last four hospitalizations for treatment of psychosis (excluding current) below
date
C0806020 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
C0033975 (UMLS CUI [1,3])
C0019993 (UMLS CUI [1,2])
C0033975 (UMLS CUI [1,3])
Admission diagnosis
Item
Admission diagnosis
text
C1628992 (UMLS CUI [1])
Birth history information collected
Item
Is information on birth history collected?
boolean
C0005603 (UMLS CUI [1,1])
C3244127 (UMLS CUI [1,2])
C3244127 (UMLS CUI [1,2])
Item
If information is not collected, select reason:
integer
C0566251 (UMLS CUI [1,1])
C0005603 (UMLS CUI [1,2])
C3244127 (UMLS CUI [1,3])
C0005603 (UMLS CUI [1,2])
C3244127 (UMLS CUI [1,3])
Code List
If information is not collected, select reason:
CL Item
Unknown (1)
CL Item
Information is unreliable (2)
Item
If information is collected, indicate sources of information:
integer
C0683836 (UMLS CUI [1,1])
C0005603 (UMLS CUI [1,2])
C0005603 (UMLS CUI [1,2])
CL Item
Patient (1)
CL Item
Family member (2)
CL Item
Patient and family member (3)
CL Item
Other (4)
Specification
Item
If Other, please specify:
text
C2348235 (UMLS CUI [1,1])
C0683836 (UMLS CUI [1,2])
C0005603 (UMLS CUI [1,3])
C0683836 (UMLS CUI [1,2])
C0005603 (UMLS CUI [1,3])
Country of birth
Item
What is patient's country of birth?
text
C1300001 (UMLS CUI [1])
year of birth of biological mother
Item
Specify year of birth of biological mother:
integer
C2826771 (UMLS CUI [1,1])
C0337486 (UMLS CUI [1,2])
C0337486 (UMLS CUI [1,2])
age, biological mother, date of birth of patient
Item
If mother's year of birth is unknown, specify age of mother when subject was born:
integer
C0001779 (UMLS CUI [1,1])
C0337486 (UMLS CUI [1,2])
C0421451 (UMLS CUI [1,3])
C0337486 (UMLS CUI [1,2])
C0421451 (UMLS CUI [1,3])
Unknown year of birth of mother
Item
Unknown year of birth of mother
boolean
C0439673 (UMLS CUI [1,1])
C2826771 (UMLS CUI [1,2])
C0337486 (UMLS CUI [1,3])
C2826771 (UMLS CUI [1,2])
C0337486 (UMLS CUI [1,3])
year of birth of biological father
Item
Specify year of birth of biological father:
integer
C2826771 (UMLS CUI [1,1])
C0337494 (UMLS CUI [1,2])
C0337494 (UMLS CUI [1,2])
age, biological father, date of birth of patient
Item
If father's year of birth is unknown, specify age of father when subject was born:
integer
C0001779 (UMLS CUI [1,1])
C0337494 (UMLS CUI [1,2])
C0421451 (UMLS CUI [1,3])
C0337494 (UMLS CUI [1,2])
C0421451 (UMLS CUI [1,3])
Unknown year of birth of father
Item
Unknown year of birth of father
boolean
C0439673 (UMLS CUI [1,1])
C2826771 (UMLS CUI [1,2])
C0337494 (UMLS CUI [1,3])
C2826771 (UMLS CUI [1,2])
C0337494 (UMLS CUI [1,3])
Item Group
Family Psychiatric history
C0748059 (UMLS CUI-1)
C0241889 (UMLS CUI-2)
C0241889 (UMLS CUI-2)
information on psychiatric family history collected
Item
Is information on psychiatric family history collected?
boolean
C3244127 (UMLS CUI [1,1])
C0748059 (UMLS CUI [1,2])
C0241889 (UMLS CUI [1,3])
C0748059 (UMLS CUI [1,2])
C0241889 (UMLS CUI [1,3])
Item
If information is not collected, select reason:
integer
C0566251 (UMLS CUI [1,1])
C0748059 (UMLS CUI [1,2])
C0241889 (UMLS CUI [1,3])
C3244127 (UMLS CUI [1,4])
C0748059 (UMLS CUI [1,2])
C0241889 (UMLS CUI [1,3])
C3244127 (UMLS CUI [1,4])
CL Item
Unknown (1)
CL Item
Information is unreliable (2)
Item
If information is collected, indicate sources of information:
integer
C0683836 (UMLS CUI [1,1])
C0748059 (UMLS CUI [1,2])
C0241889 (UMLS CUI [1,3])
C0748059 (UMLS CUI [1,2])
C0241889 (UMLS CUI [1,3])
Code List
If information is collected, indicate sources of information:
CL Item
Patient (1)
CL Item
Family member (2)
CL Item
Patient and family member (3)
CL Item
Other (4)
Psychiatric disorder, family history
Item
Is there a family history of anyone diagnosed with the following psychiatric disorder?
boolean
C0004936 (UMLS CUI [1,1])
C0241889 (UMLS CUI [1,2])
C0241889 (UMLS CUI [1,2])
Item
Diagnosis
integer
C0011900 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
C0241889 (UMLS CUI [1,3])
C0004936 (UMLS CUI [1,2])
C0241889 (UMLS CUI [1,3])
CL Item
Schizophrenia (1)
CL Item
Depression (2)
CL Item
Anxiety disorder (3)
CL Item
Bipolar disorder (4)
CL Item
Developmental disorder (5)
CL Item
Alcohol and substance abuse (6)
CL Item
Other (7)
Specification psychiatric disorder diagnosis
Item
If 'Other', please specify diagnosis:
text
C2348235 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0004936 (UMLS CUI [1,3])
C0241889 (UMLS CUI [1,4])
C0011900 (UMLS CUI [1,2])
C0004936 (UMLS CUI [1,3])
C0241889 (UMLS CUI [1,4])
Item
Family member
integer
C0086282 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0004936 (UMLS CUI [1,3])
C0011900 (UMLS CUI [1,2])
C0004936 (UMLS CUI [1,3])
CL Item
Father (1)
CL Item
Mother (2)
CL Item
Sibling(s) (3)
CL Item
Children (4)
CL Item
Grandparents, uncles, aunts (5)
CL Item
Cousin(s) (6)
CL Item
Other (7)
Specification family member with psychiatric disorder diagnosis
Item
If 'Other', please specify family member:
text
C2348235 (UMLS CUI [1,1])
C0086282 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
C0004936 (UMLS CUI [1,4])
C0086282 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
C0004936 (UMLS CUI [1,4])
Family member, psychiatric medication
Item
Is there a history of anyone in the family taking psychiatric medications?
boolean
C0086282 (UMLS CUI [1,1])
C0204585 (UMLS CUI [1,2])
C0204585 (UMLS CUI [1,2])
Item
If 'Yes', mark which family member:
integer
C2348235 (UMLS CUI [1,1])
C0086282 (UMLS CUI [1,2])
C0204585 (UMLS CUI [1,3])
C0086282 (UMLS CUI [1,2])
C0204585 (UMLS CUI [1,3])
CL Item
Father (1)
CL Item
Mother (2)
CL Item
Sibling(s) (3)
CL Item
Children (4)
CL Item
Grandparents, uncles, aunts (5)
CL Item
Cousin(s) (6)
CL Item
Other (7)
Specification family member with psychiatric medication
Item
If 'Other,' specify family member:
text
C2348235 (UMLS CUI [1,1])
C0086282 (UMLS CUI [1,2])
C0204585 (UMLS CUI [1,3])
C0086282 (UMLS CUI [1,2])
C0204585 (UMLS CUI [1,3])
Family history, hospitalization, psychiatric institution
Item
Is there a family history of anyone being hospitalized at a psychiatric institution?
boolean
C0241889 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
C1709763 (UMLS CUI [1,3])
C0019993 (UMLS CUI [1,2])
C1709763 (UMLS CUI [1,3])
Item
If 'Yes', mark which family member:
integer
C0086282 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
C1709763 (UMLS CUI [1,3])
C0019993 (UMLS CUI [1,2])
C1709763 (UMLS CUI [1,3])
Code List
If 'Yes', mark which family member:
CL Item
Father (1)
CL Item
Mother (2)
CL Item
Sibling(s) (3)
CL Item
Children (4)
CL Item
Grandparents, uncles, aunts (5)
CL Item
Cousin(s) (6)
CL Item
Other (7)
Specification family member, hospitalization, psychiatric institution
Item
If 'Other,' specify family member:
text
C2348235 (UMLS CUI [1,1])
C0086282 (UMLS CUI [1,2])
C0019993 (UMLS CUI [1,3])
C1709763 (UMLS CUI [1,4])
C0086282 (UMLS CUI [1,2])
C0019993 (UMLS CUI [1,3])
C1709763 (UMLS CUI [1,4])
Family history, attempted or completed suicide
Item
Is there a family history of attempted or completed suicide?
boolean
C0241889 (UMLS CUI [1,1])
C0852733 (UMLS CUI [1,2])
C0038663 (UMLS CUI [1,3])
C0852733 (UMLS CUI [1,2])
C0038663 (UMLS CUI [1,3])
Item
If 'Yes', mark which family member:
integer
C0086282 (UMLS CUI [1,1])
C0852733 (UMLS CUI [1,2])
C0038663 (UMLS CUI [1,3])
C0852733 (UMLS CUI [1,2])
C0038663 (UMLS CUI [1,3])
CL Item
Father (1)
CL Item
Mother (2)
CL Item
Sibling(s) (3)
CL Item
Children (4)
CL Item
Grandparents, uncles, aunts (5)
CL Item
Cousin(s) (6)
CL Item
Other (7)
Specification family member, attempted or completed suicide
Item
If 'Other,' specify family member:
text
C2348235 (UMLS CUI [1,1])
C0086282 (UMLS CUI [1,2])
C0852733 (UMLS CUI [1,3])
C0038663 (UMLS CUI [1,4])
C0086282 (UMLS CUI [1,2])
C0852733 (UMLS CUI [1,3])
C0038663 (UMLS CUI [1,4])
CL Item
Never used (1)
CL Item
Current user (2)
CL Item
Former user (3)
Number of cigarettes per day
Item
Number of cigarettes used per day
integer
C3694146 (UMLS CUI [1])
Item
Frequency
integer
C0439603 (UMLS CUI [1,1])
C0694535 (UMLS CUI [1,2])
C0694535 (UMLS CUI [1,2])
CL Item
PER HOUR (1)
CL Item
PER DAY (2)
CL Item
PER WEEK (3)
CL Item
PER MONTH (4)
CL Item
PER YEAR (5)
Years of nicotine use
Item
Years used
integer
C0694535 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
C0439234 (UMLS CUI [1,2])
Stop date smoking cigarettes
Item
If former smoker (cigarettes), specify stop date:
date
C0011008 (UMLS CUI [1,1])
C0425310 (UMLS CUI [1,2])
C0677453 (UMLS CUI [1,3])
C0425310 (UMLS CUI [1,2])
C0677453 (UMLS CUI [1,3])
CL Item
Never used (1)
CL Item
Current user (2)
CL Item
Former user (3)
Number of cigars used per day
Item
Number of cigars used per day
integer
C0459841 (UMLS CUI [1,1])
C0439505 (UMLS CUI [1,2])
C0439505 (UMLS CUI [1,2])
CL Item
PER HOUR (1)
CL Item
PER DAY (2)
CL Item
PER WEEK (3)
CL Item
PER MONTH (4)
CL Item
PER YEAR (5)
Years of cigar use
Item
Years used
integer
C0459841 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
C0439234 (UMLS CUI [1,2])
Stop date smoking cigars
Item
If former user of cigars, specify stop date:
date
C0011008 (UMLS CUI [1,1])
C0425310 (UMLS CUI [1,2])
C0678446 (UMLS CUI [1,3])
C0425310 (UMLS CUI [1,2])
C0678446 (UMLS CUI [1,3])
CL Item
Never used (1)
CL Item
Current user (2)
CL Item
Former user (3)
Number of pipes used per day
Item
Number of pipes used per day
integer
C0459842 (UMLS CUI [1,1])
C0439505 (UMLS CUI [1,2])
C0439505 (UMLS CUI [1,2])
CL Item
PER HOUR (1)
CL Item
PER DAY (2)
CL Item
PER WEEK (3)
CL Item
PER MONTH (4)
CL Item
PER YEAR (5)
Years of pipe use
Item
Years used
integer
C0459842 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
C0439234 (UMLS CUI [1,2])
Stop date smoking pipe
Item
If former user of pipes, specify stop date:
date
C0011008 (UMLS CUI [1,1])
C0425310 (UMLS CUI [1,2])
C0459842 (UMLS CUI [1,3])
C0425310 (UMLS CUI [1,2])
C0459842 (UMLS CUI [1,3])
CL Item
Never used (1)
CL Item
Current user (2)
CL Item
Former user (3)
Number smokeless tobacco used per day
Item
Number of smokeless tobacco used per day
integer
C0040338 (UMLS CUI [1,1])
C0439505 (UMLS CUI [1,2])
C0439505 (UMLS CUI [1,2])
Item
Frequency
integer
C0439603 (UMLS CUI [1,1])
C0040338 (UMLS CUI [1,2])
C0040338 (UMLS CUI [1,2])
CL Item
PER HOUR (1)
CL Item
PER DAY (2)
CL Item
PER WEEK (3)
CL Item
PER MONTH (4)
CL Item
PER YEAR (5)
Years of smokeless tobacco use
Item
Years used
integer
C0040338 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
C0439234 (UMLS CUI [1,2])
Stop date smokeless tobacco
Item
If former user of smokeless tobacco, specify stop date:
date
C0806020 (UMLS CUI [1,1])
C0040338 (UMLS CUI [1,2])
C0040338 (UMLS CUI [1,2])
Item
Nicotine patches/gum usage status
integer
C0358855 (UMLS CUI [1,1])
C0457083 (UMLS CUI [1,2])
C2073716 (UMLS CUI [2])
C0457083 (UMLS CUI [1,2])
C2073716 (UMLS CUI [2])
CL Item
Never used (1)
CL Item
Current user (2)
CL Item
Former user (3)
Number of patches/gum used per day
Item
Number of patches/gum used per day
integer
C0599654 (UMLS CUI [1,1])
C0439505 (UMLS CUI [1,2])
C0358855 (UMLS CUI [2,1])
C0439505 (UMLS CUI [2,2])
C0439505 (UMLS CUI [1,2])
C0358855 (UMLS CUI [2,1])
C0439505 (UMLS CUI [2,2])
Item
Frequency
integer
C0439603 (UMLS CUI [1,1])
C0599654 (UMLS CUI [1,2])
C0439603 (UMLS CUI [2,1])
C0358855 (UMLS CUI [2,2])
C0599654 (UMLS CUI [1,2])
C0439603 (UMLS CUI [2,1])
C0358855 (UMLS CUI [2,2])
CL Item
PER HOUR (1)
CL Item
PER DAY (2)
CL Item
PER WEEK (3)
CL Item
PER MONTH (4)
CL Item
PER YEAR (5)
Years used nicotine patches/gum
Item
Years used
integer
C0599654 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
C0358855 (UMLS CUI [2,1])
C0439234 (UMLS CUI [2,2])
C0439234 (UMLS CUI [1,2])
C0358855 (UMLS CUI [2,1])
C0439234 (UMLS CUI [2,2])
Stop date nicotine patches/gum
Item
If former user of nicotine patches/gum, specify stop date:
date
C0358855 (UMLS CUI [1,1])
C0457083 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
C0599654 (UMLS CUI [2,1])
C0457083 (UMLS CUI [2,2])
C0806020 (UMLS CUI [2,3])
C0457083 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
C0599654 (UMLS CUI [2,1])
C0457083 (UMLS CUI [2,2])
C0806020 (UMLS CUI [2,3])
Planned surgeries during trial
Item
Are there any surgeries/procedures planned which require hospitalization during the course of this trial?
boolean
C1301732 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,2])
Item
If 'Yes', specify body system:
integer
C0543467 (UMLS CUI [1,1])
C0460002 (UMLS CUI [1,2])
C0460002 (UMLS CUI [1,2])
CL Item
Eyes, ears, nose & throat (1)
CL Item
Respiratory (2)
CL Item
Cardiovascular (3)
CL Item
Gastrointestinal (4)
CL Item
Genitourinary (5)
CL Item
Musculoskeletal (6)
CL Item
Neurologic (7)
CL Item
Endocrine & metabolic (8)
CL Item
Hematopoietic/lymphatic (9)
CL Item
Dermatologic (10)
CL Item
Psychiatric (11)
CL Item
Allergic/immunologic (12)
CL Item
Reproductive/breast (13)
Surgical procedure type
Item
Surgery/procedure
text
C0332307 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,2])
Indication for surgical procedure
Item
Indication
text
C3146298 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,2])
Planned date of surgical procedure
Item
Planned date of surgery/procedure
date
C1301732 (UMLS CUI [1,1])
C4255413 (UMLS CUI [1,2])
C4255413 (UMLS CUI [1,2])
Exposure to risperidone or paliperidone
Item
Does the subject have source documentation of previous exposure to oral or injectable risperidone or paliperidone?
boolean
C0332157 (UMLS CUI [1,1])
C0073393 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C0753678 (UMLS CUI [2,2])
C0073393 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C0753678 (UMLS CUI [2,2])
Item
If 'No', specify day of tolerability testing:
integer
C0439228 (UMLS CUI [1,1])
C3274448 (UMLS CUI [1,2])
C3274448 (UMLS CUI [1,2])
CL Item
Day 1 (1)
CL Item
Day 2 (2)
CL Item
Day 3 (3)
CL Item
Day 4 (4)
CL Item
Day 5 (5)
CL Item
Day 6 (6)
Date taken
Item
Date taken
date
C0011008 (UMLS CUI [1,1])
C1290952 (UMLS CUI [1,2])
C1290952 (UMLS CUI [1,2])
Number of tablets taken daily
Item
Number of tablets taken daily
integer
C1265611 (UMLS CUI [1,1])
C1705223 (UMLS CUI [1,2])
C0439505 (UMLS CUI [1,3])
C1705223 (UMLS CUI [1,2])
C0439505 (UMLS CUI [1,3])
Tolerability testing, drug tolerance finding
Item
Did the subject adequately tolerate the tolerability test? Please take all the days of tolerability testing in consideration.
boolean
C3274448 (UMLS CUI [1,1])
C1287527 (UMLS CUI [1,2])
C1287527 (UMLS CUI [1,2])
CL Item
1st ECG obtained during Screening Phase (1)
CL Item
2nd ECG obtained during Screening Phase (2)
ECG reference number
Item
ECG reference number
integer
C1623258 (UMLS CUI [1,1])
C3274661 (UMLS CUI [1,2])
C3274661 (UMLS CUI [1,2])
Body Weight
Item
Body Weight
float
C0005910 (UMLS CUI [1])
Waist Circumference
Item
Waist Circumference
float
C0455829 (UMLS CUI [1])
Body Height
Item
Body Height
integer
C0005890 (UMLS CUI [1])
BMI
Item
Body Mass Index
float
C1305855 (UMLS CUI [1])
Pulse at rest
Item
Supine after 5 minutes rest: Pulse
integer
C0232117 (UMLS CUI [1,1])
C0443144 (UMLS CUI [1,2])
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])
CL Item
Standing (1)
CL Item
Sitting (2)
CL Item
Supine (3)
Accession number
Item
Accession number
integer
C1510755 (UMLS CUI [1])
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])
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)
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)
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])
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])
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])
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])
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])
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])
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])
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)
C0450973 (UMLS CUI-2)
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)
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])
C1883023 (UMLS CUI [1,2])
C0450973 (UMLS CUI [1,3])
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])
C0858572 (UMLS CUI [1,2])
C0450973 (UMLS CUI [1,3])
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])
C0858572 (UMLS CUI [1,2])
C0450973 (UMLS CUI [1,3])
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])
C4068836 (UMLS CUI [1,2])
C0450973 (UMLS CUI [1,3])
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])
C1705648 (UMLS CUI [1,2])
C0450973 (UMLS CUI [1,3])
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)
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)
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)
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) Baseline Version
C3639710 (UMLS CUI-1)
SSRS: Wish to be dead
Item
Suicidal Ideation: Wish to be dead
boolean
C3830638 (UMLS CUI [1])
SSRS: Description of wish to be dead
Item
Suicidal Ideation: If 'Yes', describe:
text
C3830662 (UMLS CUI [1])
SSRS: Non-specific active suicidal thoughts
Item
Suicidal Ideation: Non-specific active suicidal thoughts
boolean
C3830647 (UMLS CUI [1])
SSRS: Description of Non-Specific Active Suicidal Thoughts
Item
Suicidal Ideation: If 'Yes', describe:
text
C3830664 (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
C3830676 (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
C3830669 (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
C3830675 (UMLS CUI [1])
SSRS: Description of Active Suicidal Ideation with Some Intent to Act, without Specific Plan
Item
Suicidal Ideation: If 'Yes', describe:
text
C3830668 (UMLS CUI [1])
SSRS: Active suicidal ideation with specific plan and intent
Item
Suicidal Ideation: Active suicidal ideation with specific plan and intent
boolean
C3830674 (UMLS CUI [1])
SSRS: Description of Active Suicidal Ideation with Specific Plan and Intent
Item
Suicidal Ideation: If 'Yes', describe:
text
C3830667 (UMLS CUI [1])
Item
Intensity of Ideation: Most Severe Ideation
integer
C3639916 (UMLS CUI [1])
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
C3639917 (UMLS CUI [1])
Item
Intensity of Ideation: Frequency of Most Severe Ideation
integer
C3639918 (UMLS CUI [1])
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
C3639919 (UMLS CUI [1])
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
C3639920 (UMLS CUI [1])
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
C3639921 (UMLS CUI [1])
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
C3639922 (UMLS CUI [1])
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
C3639923 (UMLS CUI [1])
SSRS: Number of Actual Suicide Attempts
Item
Suicidal Behavior: If 'Yes', specify total number of attempts:
integer
C3639924 (UMLS CUI [1])
SSRS: Description of Actual Suicide Attempts
Item
Suicidal Behavior: If 'Yes', describe:
text
C3639925 (UMLS CUI [1])
SSRS: Non-suicidal self-injurious behavior
Item
Suicidal Behavior: Non-suicidal self-injurious behavior
boolean
C3639926 (UMLS CUI [1])
SSRS: Interrupted Suicide Attempt
Item
Suicidal Behavior: Interrupted attempt
boolean
C3639927 (UMLS CUI [1])
SSRS: Number of Interrupted Suicide Attempts
Item
Suicidal Behavior: If 'Yes', specify total number of interrupted attempts:
integer
C3639928 (UMLS CUI [1])
SSRS: Description of Actual Suicide Attempts
Item
Suicidal Behavior: If 'Yes', describe:
text
C3639929 (UMLS CUI [1])
SSRS: Aborted Suicide Attempt
Item
Suicidal Behavior: Aborted attempt
boolean
C3639930 (UMLS CUI [1])
SSRS: Number of Aborted Suicide Attempts
Item
Suicidal Behavior: If 'Yes', specify total number of aborted attempts:
integer
C3639931 (UMLS CUI [1])
SSRS: Description of Aborted Suicide Attempt
Item
Suicidal Behavior: If 'Yes', describe:
text
C3639932 (UMLS CUI [1])
SSRS: Preparatory Acts or Behaviors Toward Suicide Attempt
Item
Suicidal Behavior: Preparatory acts or behavior toward suicide attempt
boolean
C3639933 (UMLS CUI [1])
SSRS: Description of Preparatory Acts or Behaviors Toward Suicide Attempt
Item
Suicidal Behavior: If 'Yes', describe:
text
C3639934 (UMLS CUI [1])
SSRS: Suicidal Behavior
Item
Suicidal Behavior
boolean
C3639935 (UMLS CUI [1])
SSRS: Most Recent Suicide Attempt Date
Item
Suicidal Behavior - Actual Attempts: Most recent attempt date
date
C3639936 (UMLS CUI [1])
Item
Suicidal Behavior - Actual Attempts: Most Recent Suicide Attempt actual lethality/medical damage
integer
C3639937 (UMLS CUI [1])
Code List
Suicidal Behavior - Actual Attempts: Most Recent 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 Recent Suicide Attempt potential lethality
integer
C3639938 (UMLS CUI [1])
Code List
Suicidal Behavior - Actual Attempts: Most Recent 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)
SSRS: Most Lethal Suicide Attempt Date
Item
Suicidal Behavior - Actual Attempts: Most lethal attempt date
date
C3639939 (UMLS CUI [1])
Item
Suicidal Behavior - Actual Attempts: Most Lethal Suicide Attempt actual lethality/medical damage
integer
C3639940 (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
C3639941 (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)
SSRS: First Suicide Attempt Date
Item
Suicidal Behavior - Actual Attempts: Initial/first attempt date
date
C3639942 (UMLS CUI [1])
Item
Suicidal Behavior - Actual Attempts: First Suicide Attempt actual lethality/medical damage
integer
C3639943 (UMLS CUI [1])
Code List
Suicidal Behavior - Actual Attempts: First 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: First Suicide Attempt Potential Lethality
integer
C3639944 (UMLS CUI [1])
Code List
Suicidal Behavior - Actual Attempts: First 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
Positive and Negative Syndrome Scale for Schizophrenia
C4086747 (UMLS CUI-1)
C0036341 (UMLS CUI-2)
C0036341 (UMLS CUI-2)
Rater's initials
Item
Rater's initials
text
C3166278 (UMLS CUI [1])
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])
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])
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)
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)
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])
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)
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)
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])
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)
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])
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])
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)
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])
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)
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])
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])
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])
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])
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])
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])
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])
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])
C0449820 (UMLS CUI [1,2])