Screening - CRFs Paliperidone Palmitate Schizophrenia NCT01515423 - Portale di modelli di dati medici (MDM-Portal)

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])

Protocol version, informed consent

Item

Which protocol version did the subject first consent to?

integer

C2985700 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])

Protocol version, informed consent

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])

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])

Re-consent protocol version

Item

Re-consent protocol version:

integer

C0205436 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C2985700 (UMLS CUI [1,3])

Re-consent protocol version

Code List

Re-consent protocol version:

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])

Date of birth

Item

Date of birth

date

C0421451 (UMLS CUI [1])

Unknown date of birth

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])

Unknown date of birth

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])

Sex

Item

Sex

integer

Sex

Code List

Sex

CL Item

Male (1)

CL Item

Female (2)

CL Item

Unknown (3)

CL Item

Undifferentiated (4)

Ethnicity

Item

Ethnicity

integer

C0015031 (UMLS CUI [1])

Ethnicity

Code List

Ethnicity

CL Item

Hispanic or Latino (1)

CL Item

Not Hispanic or Latino (2)

CL Item

Unknown (3)

CL Item

Not reported (4)

Race

Item

Race

integer

C0034510 (UMLS CUI [1])

Race

Code List

Race

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])

Asians

Item

Asian sub-category

integer

C0078988 (UMLS CUI [1])

Asians

Code List

Asian sub-category

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])

eligibility criteria

Item

Has the subject failed to satisfy any protocol eligibility criteria?

boolean

C1516637 (UMLS CUI [1,1])
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])

Inclusion/Exclusion category

Item

Inclusion/Exclusion category

integer

C1704756 (UMLS CUI [1])

Inclusion/Exclusion category

Code List

Inclusion/Exclusion category

CL Item

INCLUSION (1)

CL Item

EXCLUSION (2)

Criteria number

Item

Criteria number

integer

C0243161 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])

Type of Schizophrenia

Item

Type of Schizophrenia

integer

C0036341 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])

Type of Schizophrenia

Code List

Type of Schizophrenia

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])

Date of current exacerbation

Item

Date of current exacerbation

date

C0011008 (UMLS CUI [1,1])
C0270383 (UMLS CUI [1,2])

Clinical course

Item

Course

integer

C0449259 (UMLS CUI [1,1])
C0036341 (UMLS CUI [1,2])

Clinical course

Code List

Course

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])

Body system

Item

Body system

integer

C0460002 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])

Body system

Code List

Body system

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])

Abnormality ongoing at study entry

Item

Abnormality ongoing at study entry

boolean

C1704258 (UMLS CUI [1,1])
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])

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])

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])

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])

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])

Reason for no collection of birth history information

Item

If information is not collected, select reason:

integer

C0566251 (UMLS CUI [1,1])
C0005603 (UMLS CUI [1,2])
C3244127 (UMLS CUI [1,3])

Reason for no collection of birth history information

Code List

If information is not collected, select reason:

CL Item

Unknown (1)

CL Item

Information is unreliable (2)

Sources of information, birth history

Item

If information is collected, indicate sources of information:

integer

C0683836 (UMLS CUI [1,1])
C0005603 (UMLS CUI [1,2])

undefined item

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)

Specification

Item

If Other, please specify:

text

C2348235 (UMLS CUI [1,1])
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])

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])

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])

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])

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])

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])

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])

Reason for no collection of family psychiatric history information

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])

undefined item

Code List

If information is not collected, select reason:

CL Item

Unknown (1)

CL Item

Information is unreliable (2)

source of information, family psychiatric history

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])

source of information, family psychiatric history

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])

Diagnosis

Item

Diagnosis

integer

C0011900 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
C0241889 (UMLS CUI [1,3])

Diagnosis

Code List

Diagnosis

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])

Family member

Item

Family member

integer

C0086282 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0004936 (UMLS CUI [1,3])

Family member

Code List

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 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])

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])

Family member with psychiatric medication

Item

If 'Yes', mark which family member:

integer

C2348235 (UMLS CUI [1,1])
C0086282 (UMLS CUI [1,2])
C0204585 (UMLS CUI [1,3])

Specification

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 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])

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])

Family member, hospitalization, psychiatric institution

Item

If 'Yes', mark which family member:

integer

C0086282 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
C1709763 (UMLS CUI [1,3])

Family member, hospitalization, psychiatric institution

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])

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])

Family member, attempted or completed suicide

Item

If 'Yes', mark which family member:

integer

C0086282 (UMLS CUI [1,1])
C0852733 (UMLS CUI [1,2])
C0038663 (UMLS CUI [1,3])

undefined item

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, 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])

Cigarette use

Item

Cigarettes usage status

integer

C0694535 (UMLS CUI [1])

Tobacco use

Code List

Cigarettes usage status

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])

Frequency smoking cigarettes

Item

Frequency

integer

C0439603 (UMLS CUI [1,1])
C0694535 (UMLS CUI [1,2])

Frequency

Code List

Frequency

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])

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])

History of smoking cigars

Item

Cigars usage status

integer

C2242892 (UMLS CUI [1])

History of smoking cigars

Code List

Cigars usage status

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])

Frequency smoking cigars

Item

Frequency

integer

C0439603 (UMLS CUI [1,1])
C0459841 (UMLS CUI [1,2])

Frequency

Code List

Frequency

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])

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])

Pipe use

Item

Pipe usage status

integer

C0240766 (UMLS CUI [1])

Pipe use

Code List

Pipe usage status

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])

Frequency smoking pipe

Item

Frequency

integer

C0439603 (UMLS CUI [1,1])
C0459842 (UMLS CUI [1,2])

Frequency

Code List

Frequency

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])

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])

Smokeless tobacco use

Item

Smokeless tobacco usage status

integer

C4075678 (UMLS CUI [1])

Smokeless tobacco use

Code List

Smokeless tobacco usage status

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])

Frequency using smokeless tobacco

Item

Frequency

integer

C0439603 (UMLS CUI [1,1])
C0040338 (UMLS CUI [1,2])

Frequency using smokeless tobacoo

Code List

Frequency

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])

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])

Nicotine patches/gum use

Item

Nicotine patches/gum usage status

integer

C0358855 (UMLS CUI [1,1])
C0457083 (UMLS CUI [1,2])
C2073716 (UMLS CUI [2])

Nicotine patches/gum use

Code List

Nicotine patches/gum usage status

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])

Frequency using nicotine patches/gum

Item

Frequency

integer

C0439603 (UMLS CUI [1,1])
C0599654 (UMLS CUI [1,2])
C0439603 (UMLS CUI [2,1])
C0358855 (UMLS CUI [2,2])

Frequency using nicotine patches/gum

Code List

Frequency

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])

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])

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])

Surgical procedure, body system

Item

If 'Yes', specify body system:

integer

C0543467 (UMLS CUI [1,1])
C0460002 (UMLS CUI [1,2])

Surgical procedure, body system

Code List

If 'Yes', specify body system:

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])

Indication for surgical procedure

Item

Indication

text

C3146298 (UMLS CUI [1,1])
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])

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])

Day of tolerability testing

Item

If 'No', specify day of tolerability testing:

integer

C0439228 (UMLS CUI [1,1])
C3274448 (UMLS CUI [1,2])

Day of tolerability testing

Code List

If 'No', specify day of tolerability testing:

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])

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])

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])

Timepoint ECG

Item

Timepoint

integer

C2348792 (UMLS CUI [1,1])
C1290952 (UMLS CUI [1,2])

Timepoint ECG

Code List

Timepoint

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])

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])

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])

Patient position finding

Item

Actual Position

integer

C0449850 (UMLS CUI [1])

Patient position finding

Code List

Actual Position

CL Item

Standing (1)

CL Item

Sitting (2)

CL Item

Supine (3)

Accession number

Item

Accession number

integer

C1510755 (UMLS CUI [1])

AIMS: Muscles of facial expression

Item

Facial and oral movements: Muscles of facial expression

integer

C3640439 (UMLS CUI [1])

AIMS: Muscles of facial expression

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)

AIMS: Lips and perioral area

Item

Facial and oral movements: Lips and perioral area

integer

C3640440 (UMLS CUI [1])

AIMS: Lips and perioral area

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)

AIMS: Jaw

Item

Facial and oral movements: Jaw

integer

C3640441 (UMLS CUI [1])

AIMS: Jaw

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)

AIMS: Tongue

Item

Facial and oral movements: Tongue

integer

C3640442 (UMLS CUI [1])

AIMS: Tongue

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)

AIMS: Upper arm

Item

Extremity movements: Upper (arms, wrists, hands, fingers)

integer

C3640443 (UMLS CUI [1])

AIMS: Upper arm

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)

AIMS: Lower extremities

Item

Extremity movements: Lower (legs, knees, ankles, toes)

integer

C3640444 (UMLS CUI [1])

AIMS: Lower extremities

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)

AIMS: Neck, shoulders, hip

Item

Trunk movements: Neck, shoulders, hip

integer

C3640445 (UMLS CUI [1])

AIMS: Neck, shoulders, hip

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)

AIMS: Severity of abnormal movements

Item

Global Judgements: Severity of abnormal movements

integer

C3640446 (UMLS CUI [1])

AIMS: Severity of abnormal movements

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)

AIMS: Incapacitation due to abnormal movements

Item

Global Judgements: Incapacitation due to abnormal movements

integer

C3640447 (UMLS CUI [1])

AIMS: Incapacitation due to abnormal movements

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)

AIMS: Subject's awareness of abnormal movements

Item

Global Judgements: Subject's awareness of abnormal movements

integer

C3640448 (UMLS CUI [1])

AIMS: Subject's awareness of abnormal movements

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)

AIMS: Current problems with teeth and/or dentures

Item

Dental Status: Current problems with teeth and/or dentures

integer

C3640449 (UMLS CUI [1])

AIMS: Current problems with teeth and/or dentures

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])

BARS: Objective

Item

Objective

integer

C3640451 (UMLS CUI [1])

Objective

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)

BARS: Awareness of restlessness

Item

Subjective: Awareness of restlessness

integer

C3640452 (UMLS CUI [1])

BARS: Awareness of restlessness

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)

BARS: Reported distress related to restlessness

Item

Subjective: Reported distress related to restlessness

integer

C3640453 (UMLS CUI [1])

BARS: Reported distress related to restlessness

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)

BARS: Global clinical rating of akathisia

Item

Global clinical rating of akathisia

integer

C3640454 (UMLS CUI [1])

BARS: Global clinical rating of akathisia

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)

Gait

Item

1 Gait

integer

C0016928 (UMLS CUI [1,1])
C0450973 (UMLS CUI [1,2])

undefined item

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)

Arm dropping

Item

2 Arm Dropping

integer

C0231650 (UMLS CUI [1,1])
C0450973 (UMLS CUI [1,2])

undefined item

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)

Shoulder shaking

Item

3 Shoulder shaking

integer

C0037004 (UMLS CUI [1,1])
C1883023 (UMLS CUI [1,2])
C0450973 (UMLS CUI [1,3])

undefined item

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)

Elbow rigidity

Item

4 Elbow rigidity

integer

C0013769 (UMLS CUI [1,1])
C0858572 (UMLS CUI [1,2])
C0450973 (UMLS CUI [1,3])

undefined item

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)

Wrist rigidity

Item

5 Wrist rigidity

integer

C0043262 (UMLS CUI [1,1])
C0858572 (UMLS CUI [1,2])
C0450973 (UMLS CUI [1,3])

undefined item

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)

Leg pendulousness

Item

6 Leg pendulousness

integer

C1140621 (UMLS CUI [1,1])
C4068836 (UMLS CUI [1,2])
C0450973 (UMLS CUI [1,3])

undefined item

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)

Head dropping

Item

7 Head dropping

integer

C0018670 (UMLS CUI [1,1])
C1705648 (UMLS CUI [1,2])
C0450973 (UMLS CUI [1,3])

undefined item

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)

Glabella tap

Item

8 Glabella tap

integer

C0576550 (UMLS CUI [1,1])
C0450973 (UMLS CUI [1,2])

undefined item

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)

Tremor

Item

9 Tremor

integer

C0040822 (UMLS CUI [1,1])
C0450973 (UMLS CUI [1,2])

undefined item

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)

Salivation

Item

10 Salivation

integer

C0036104 (UMLS CUI [1,1])
C0450973 (UMLS CUI [1,2])

undefined item

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)

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])

SSRS: Most Severe Ideation

Item

Intensity of Ideation: Most Severe Ideation

integer

C3639916 (UMLS CUI [1])

SSRS: Most Severe Ideation

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

C3639917 (UMLS CUI [1])

SSRS: Frequency

Item

Intensity of Ideation: Frequency of Most Severe Ideation

integer

C3639918 (UMLS CUI [1])

SSRS: Frequency

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)

SSRS: Duration

Item

Intensity of Ideation: Duration of Most Severe Ideation

integer

C3639919 (UMLS CUI [1])

SSRS: Duration

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)

SSRS: Controllability

Item

Intensity of Ideation: Controllability of Most Severe Ideation

integer

C3639920 (UMLS CUI [1])

SSRS: Controllability

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)

SSRS: Deterrents

Item

Intensity of Ideation: Deterrents to Most Severe Ideation

integer

C3639921 (UMLS CUI [1])

SSRS: Deterrents

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)

SSRS: Reasons for ideation

Item

Intensity of Ideation: Reasons for Most Severe Ideation

integer

C3639922 (UMLS CUI [1])

SSRS: Reasons for ideation

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

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])

SSRS: Most Recent Suicide Attempt Damage

Item

Suicidal Behavior - Actual Attempts: Most Recent Suicide Attempt actual lethality/medical damage

integer

C3639937 (UMLS CUI [1])

SSRS: Most Recent Suicide Attempt Damage

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)

SSRS: Most Recent Suicide Attempt Potential

Item

Suicidal Behavior - Actual Attempts: Most Recent Suicide Attempt potential lethality

integer

C3639938 (UMLS CUI [1])

SSRS: Most Recent Suicide Attempt Potential

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])

SSRS: Most Lethal Suicide Attempt Damage

Item

Suicidal Behavior - Actual Attempts: Most Lethal Suicide Attempt actual lethality/medical damage

integer

C3639940 (UMLS CUI [1])

SSRS: Most Lethal Suicide Attempt Damage

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)

SSRS: Most Lethal Suicide Attempt Potential

Item

Suicidal Behavior - Actual Attempts: Most Lethal Suicide Attempt potential lethality

integer

C3639941 (UMLS CUI [1])

SSRS: Most Lethal Suicide Attempt Potential

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])

SSRS: First Suicide Attempt Damage

Item

Suicidal Behavior - Actual Attempts: First Suicide Attempt actual lethality/medical damage

integer

C3639943 (UMLS CUI [1])

SSRS: First Suicide Attempt Damage

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)

SSRS: First Suicide Attempt Potential

Item

Suicidal Behavior - Actual Attempts: First Suicide Attempt Potential Lethality

integer

C3639944 (UMLS CUI [1])

SSRS: First Suicide Attempt Potential

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)

Rater's initials

Item

Rater's initials

text

C3166278 (UMLS CUI [1])

PANSS: Delusions

Item

Positive subscale: P01 Delusions

integer

C4087066 (UMLS CUI [1])

Delusions

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)

PANSS: Conceptual disorganization

Item

Positive subscale: P02 Conceptual disorganization

integer

C4086687 (UMLS CUI [1])

PANSS: Conceptual disorganization

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)

PANSS: Hallucinatory behavior

Item

Positive subscale: P03 Hallucinatory behavior

integer

C4086696 (UMLS CUI [1])

PANSS: Hallucinatory behavior

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)

PANSS: Excitement

Item

Positive subscale: P04 Excitement

integer

C4086693 (UMLS CUI [1])

PANSS: Excitement

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)

PANSS: Grandiosity

Item

Positive subscale: P05 Grandiosity

integer

C4086694 (UMLS CUI [1])

PANSS: Grandiosity

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)

PANSS: Suspiciousness/persecution

Item

Positive subscale: P06 Suspiciousness/persecution

integer

C4087067 (UMLS CUI [1])

PANSS: Suspiciousness/persecution

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)

PANSS: Hostility

Item

Positive subscale: P07 Hostility

integer

C4086697 (UMLS CUI [1])

PANSS: Hostility

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)

PANSS: Blunted affect

Item

Negative subscale: N01 Blunted affect

integer

C4086686 (UMLS CUI [1])

PANSS: Blunted affect

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)

PANSS: Emotional withdrawal

Item

Negative subscale: N02 Emotional withdrawal

integer

C4086692 (UMLS CUI [1])

PANSS: Emotional withdrawal

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)

PANSS: Poor rapport

Item

Negative subscale: N03 Poor rapport

integer

C4086705 (UMLS CUI [1])

PANSS: Poor rapport

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)

PANSS: Passive/apathetic social withdrawal

Item

Negative subscale: N04 Passive/apathetic social withdrawal

integer

C4086702 (UMLS CUI [1])

PANSS: Passive/apathetic social withdrawal

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)

PANSS: Difficulty in abstract thinking

Item

Negative subscale: N05 Difficulty in abstract thinking

integer

C4086689 (UMLS CUI [1])

PANSS: Difficulty in abstract thinking

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)

PANSS: Lack of spontaneity and flow of conversation

Item

Negative subscale: N06 Lack of spontaneity and flow of conversation

integer

C4086699 (UMLS CUI [1])

PANSS: Lack of spontaneity and flow of conversation

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)

PANSS: Stereotyped thinking

Item

Negative subscale: N07 Stereotyped thinking

integer

C4086708 (UMLS CUI [1])

PANSS: Stereotyped thinking

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)

PANSS: Somatic concern

Item

General psychopathology subscale: G01 Somatic concern

integer

C4086707 (UMLS CUI [1])

PANSS: Somatic concern

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)

PANSS: Anxiety

Item

General psychopathology subscale: G02 Anxiety

integer

C4086685 (UMLS CUI [1])

PANSS: Anxiety

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)

PANSS: Guilt feelings

Item

General psychopathology subscale: G03 Guilt feelings

integer

C4086695 (UMLS CUI [1])

PANSS: Guilt feelings

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)

PANSS: Tension

Item

General psychopathology subscale: G04 Tension

integer

C4086709 (UMLS CUI [1])

PANSS: Tension

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)

PANSS: Mannerisms and posturing

Item

General psychopathology subscale: G05 Mannerisms and posturing

integer

C4086700 (UMLS CUI [1])

PANSS: Mannerisms and posturing

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)

PANSS: Depression

Item

General psychopathology subscale: G06 Depression

integer

C4086688 (UMLS CUI [1])

PANSS: Depression

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)

PANSS: Motor retardation

Item

General psychopathology subscale: G07 Motor retardation

integer

C4086701 (UMLS CUI [1])

PANSS: Motor retardation

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)

PANSS: Uncooperativeness

Item

General psychopathology subscale: G08 Uncooperativeness

integer

C4086710 (UMLS CUI [1])

PANSS: Uncooperativeness

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)

PANSS: Unusual thought content

Item

General psychopathology subscale: G09 Unusual thought content

integer

C4086711 (UMLS CUI [1])

PANSS: Unusual thought content

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)

PANSS: Disorientation

Item

General psychopathology subscale: G10 Disorientation

integer

C4086690 (UMLS CUI [1])

PANSS: Disorientation

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)

PANSS: Poor attention

Item

General psychopathology subscale: G11 Poor attention

integer

C4086703 (UMLS CUI [1])

PANSS: Poor attention

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)

PANSS: Lack of judgment and insight

Item

General psychopathology subscale: G12 Lack of judgment and insight

integer

C4086698 (UMLS CUI [1])

PANSS: Lack of judgment and insight

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)

PANSS: Disturbance of volition

Item

General psychopathology subscale: G13 Disturbance of volition

integer

C4086691 (UMLS CUI [1])

PANSS: Disturbance of volition

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)

PANSS: Poor impulse control

Item

General psychopathology subscale: G14 Poor impulse control

integer

C4086704 (UMLS CUI [1])

PANSS: Poor impulse control

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)

PANSS: Preoccupation

Item

General psychopathology subscale: G15 Preoccupation

integer

C4086706 (UMLS CUI [1])

PANSS: Preoccupation

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)

PANSS: Active social avoidence

Item

General psychopathology subscale: G16 Active social avoidence

integer

C4086684 (UMLS CUI [1])

PANSS: Active social avoidence

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])

ID

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Screening - CRFs Paliperidone Palmitate Schizophrenia NCT01515423