ID

22188

Descripción

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

Palabras clave

  1. 22/5/17 22/5/17 -
Subido en

22 de mayo de 2017

DOI

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Licencia

Creative Commons BY 4.0

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Visit 7 - CRFs Paliperidone Palmitate Schizophrenia NCT01515423

Visit 7 - CRFs Paliperidone Palmitate Schizophrenia NCT01515423

Date of visit
Descripción

Date of visit

Alias
UMLS CUI-1
C1320303
Visit date
Descripción

Date of visit

Tipo de datos

date

Unidades de medida
  • dd.mm.yyyy
Alias
UMLS CUI [1]
C1320303
dd.mm.yyyy
Vital Signs Pulse and Blood Pressure
Descripción

Vital Signs Pulse and Blood Pressure

Alias
UMLS CUI-1
C0518766
Supine after 5 minutes rest: Pulse
Descripción

Pulse at rest

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1,1]
C0232117
UMLS CUI [1,2]
C0443144
beats/min
Supine after 5 minutes rest: Systolic Blood Pressure
Descripción

SBP at rest

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C2039694
mmHg
Supine after 5 minutes rest: Diastolic Blood Pressure
Descripción

DBP at rest

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C2183311
mmHg
Standing after 2 minutes: Pulse
Descripción

Pulse while standing

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1]
C2029905
beats/min
Standing after 2 minutes: Systolic Blood Pressure
Descripción

SBP standing

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C1303018
mmHg
Standing after 2 minutes: Diastolic Blood Pressure
Descripción

DBP standing

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C1303019
mmHg
Actual Position
Descripción

Patient position finding

Tipo de datos

integer

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

PK Blood Sample: Paliperidone

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

Specimen taken

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1277698
Accession number
Descripción

Accession number

Tipo de datos

integer

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

Comment, blood specimen

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0178913
Positive and Negative Syndrome Scale for Schizophrenia
Descripción

Positive and Negative Syndrome Scale for Schizophrenia

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

Rater's initials

Tipo de datos

text

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

PANSS: Delusions

Tipo de datos

integer

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

PANSS: Conceptual disorganization

Tipo de datos

integer

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

PANSS: Hallucinatory behavior

Tipo de datos

integer

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

PANSS: Excitement

Tipo de datos

integer

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

PANSS: Grandiosity

Tipo de datos

integer

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

PANSS: Suspiciousness/persecution

Tipo de datos

integer

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

PANSS: Hostility

Tipo de datos

integer

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

PANSS: Blunted affect

Tipo de datos

integer

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

PANSS: Emotional withdrawal

Tipo de datos

integer

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

PANSS: Poor rapport

Tipo de datos

integer

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

PANSS: Passive/apathetic social withdrawal

Tipo de datos

integer

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

PANSS: Difficulty in abstract thinking

Tipo de datos

integer

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

PANSS: Lack of spontaneity and flow of conversation

Tipo de datos

integer

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

PANSS: Stereotyped thinking

Tipo de datos

integer

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

PANSS: Somatic concern

Tipo de datos

integer

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

PANSS: Anxiety

Tipo de datos

integer

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

PANSS: Guilt feelings

Tipo de datos

integer

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

PANSS: Tension

Tipo de datos

integer

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

PANSS: Mannerisms and posturing

Tipo de datos

integer

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

PANSS: Depression

Tipo de datos

integer

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

PANSS: Motor retardation

Tipo de datos

integer

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

PANSS: Uncooperativeness

Tipo de datos

integer

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

PANSS: Unusual thought content

Tipo de datos

integer

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

PANSS: Disorientation

Tipo de datos

integer

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

PANSS: Poor attention

Tipo de datos

integer

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

PANSS: Lack of judgment and insight

Tipo de datos

integer

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

PANSS: Disturbance of volition

Tipo de datos

integer

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

PANSS: Poor impulse control

Tipo de datos

integer

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

PANSS: Preoccupation

Tipo de datos

integer

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

PANSS: Active social avoidence

Tipo de datos

integer

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

Calculated total PANSS score

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C4086747
UMLS CUI [1,2]
C0449820
Clinical Global Impression - Severity
Descripción

Clinical Global Impression - Severity

Alias
UMLS CUI-1
C3639708
Rater´s initials
Descripción

Rater´s initials

Tipo de datos

text

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

Clinical global impression of subject's psychotic disorder

Tipo de datos

integer

Alias
UMLS CUI [1]
C3698629

Similar models

Visit 7 - CRFs Paliperidone Palmitate Schizophrenia NCT01515423

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Date of visit
C1320303 (UMLS CUI-1)
Date of visit
Item
Visit date
date
C1320303 (UMLS CUI [1])
Item Group
Vital Signs Pulse and Blood Pressure
C0518766 (UMLS CUI-1)
Pulse at rest
Item
Supine after 5 minutes rest: Pulse
integer
C0232117 (UMLS CUI [1,1])
C0443144 (UMLS CUI [1,2])
SBP at rest
Item
Supine after 5 minutes rest: Systolic Blood Pressure
integer
C2039694 (UMLS CUI [1])
DBP at rest
Item
Supine after 5 minutes rest: Diastolic Blood Pressure
integer
C2183311 (UMLS CUI [1])
Pulse while standing
Item
Standing after 2 minutes: Pulse
integer
C2029905 (UMLS CUI [1])
SBP standing
Item
Standing after 2 minutes: Systolic Blood Pressure
integer
C1303018 (UMLS CUI [1])
DBP standing
Item
Standing after 2 minutes: Diastolic Blood Pressure
integer
C1303019 (UMLS CUI [1])
Item
Actual Position
integer
C0449850 (UMLS CUI [1])
Code List
Actual Position
CL Item
Standing (1)
CL Item
Sitting (2)
CL Item
Supine (3)
Item Group
PK Blood Sample: Paliperidone
C0201734 (UMLS CUI-1)
C0178913 (UMLS CUI-2)
C0753678 (UMLS CUI-3)
Specimen taken
Item
Specimen taken
boolean
C1277698 (UMLS CUI [1])
Accession number
Item
Accession number
integer
C1510755 (UMLS CUI [1,1])
C2826726 (UMLS CUI [1,2])
Comment, blood specimen
Item
Specimen comments, if any
text
C0947611 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
Item Group
Positive and Negative Syndrome Scale for Schizophrenia
C4086747 (UMLS CUI-1)
C0036341 (UMLS CUI-2)
Rater's initials
Item
Rater's initials
text
C3166278 (UMLS CUI [1])
Item
Positive subscale: P01 Delusions
integer
C4087066 (UMLS CUI [1])
Code List
Positive subscale: P01 Delusions
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
Positive subscale: P02 Conceptual disorganization
integer
C4086687 (UMLS CUI [1])
Code List
Positive subscale: P02 Conceptual disorganization
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
Positive subscale: P03 Hallucinatory behavior
integer
C4086696 (UMLS CUI [1])
Code List
Positive subscale: P03 Hallucinatory behavior
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
Positive subscale: P04 Excitement
integer
C4086693 (UMLS CUI [1])
Code List
Positive subscale: P04 Excitement
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
Positive subscale: P05 Grandiosity
integer
C4086694 (UMLS CUI [1])
Code List
Positive subscale: P05 Grandiosity
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
Positive subscale: P06 Suspiciousness/persecution
integer
C4087067 (UMLS CUI [1])
Code List
Positive subscale: P06 Suspiciousness/persecution
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
Positive subscale: P07 Hostility
integer
C4086697 (UMLS CUI [1])
Code List
Positive subscale: P07 Hostility
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
Negative subscale: N01 Blunted affect
integer
C4086686 (UMLS CUI [1])
Code List
Negative subscale: N01 Blunted affect
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
Negative subscale: N02 Emotional withdrawal
integer
C4086692 (UMLS CUI [1])
Code List
Negative subscale: N02 Emotional withdrawal
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
Negative subscale: N03 Poor rapport
integer
C4086705 (UMLS CUI [1])
Code List
Negative subscale: N03 Poor rapport
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
Negative subscale: N04 Passive/apathetic social withdrawal
integer
C4086702 (UMLS CUI [1])
Code List
Negative subscale: N04 Passive/apathetic social withdrawal
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
Negative subscale: N05 Difficulty in abstract thinking
integer
C4086689 (UMLS CUI [1])
Code List
Negative subscale: N05 Difficulty in abstract thinking
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
Negative subscale: N06 Lack of spontaneity and flow of conversation
integer
C4086699 (UMLS CUI [1])
Code List
Negative subscale: N06 Lack of spontaneity and flow of conversation
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
Negative subscale: N07 Stereotyped thinking
integer
C4086708 (UMLS CUI [1])
Code List
Negative subscale: N07 Stereotyped thinking
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
General psychopathology subscale: G01 Somatic concern
integer
C4086707 (UMLS CUI [1])
Code List
General psychopathology subscale: G01 Somatic concern
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
General psychopathology subscale: G02 Anxiety
integer
C4086685 (UMLS CUI [1])
Code List
General psychopathology subscale: G02 Anxiety
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
General psychopathology subscale: G03 Guilt feelings
integer
C4086695 (UMLS CUI [1])
Code List
General psychopathology subscale: G03 Guilt feelings
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
General psychopathology subscale: G04 Tension
integer
C4086709 (UMLS CUI [1])
Code List
General psychopathology subscale: G04 Tension
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
General psychopathology subscale: G05 Mannerisms and posturing
integer
C4086700 (UMLS CUI [1])
Code List
General psychopathology subscale: G05 Mannerisms and posturing
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
General psychopathology subscale: G06 Depression
integer
C4086688 (UMLS CUI [1])
Code List
General psychopathology subscale: G06 Depression
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
General psychopathology subscale: G07 Motor retardation
integer
C4086701 (UMLS CUI [1])
Code List
General psychopathology subscale: G07 Motor retardation
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
General psychopathology subscale: G08 Uncooperativeness
integer
C4086710 (UMLS CUI [1])
Code List
General psychopathology subscale: G08 Uncooperativeness
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
General psychopathology subscale: G09 Unusual thought content
integer
C4086711 (UMLS CUI [1])
Code List
General psychopathology subscale: G09 Unusual thought content
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
General psychopathology subscale: G10 Disorientation
integer
C4086690 (UMLS CUI [1])
Code List
General psychopathology subscale: G10 Disorientation
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
General psychopathology subscale: G11 Poor attention
integer
C4086703 (UMLS CUI [1])
Code List
General psychopathology subscale: G11 Poor attention
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
General psychopathology subscale: G12 Lack of judgment and insight
integer
C4086698 (UMLS CUI [1])
Code List
General psychopathology subscale: G12 Lack of judgment and insight
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
General psychopathology subscale: G13 Disturbance of volition
integer
C4086691 (UMLS CUI [1])
Code List
General psychopathology subscale: G13 Disturbance of volition
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
General psychopathology subscale: G14 Poor impulse control
integer
C4086704 (UMLS CUI [1])
Code List
General psychopathology subscale: G14 Poor impulse control
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
General psychopathology subscale: G15 Preoccupation
integer
C4086706 (UMLS CUI [1])
Code List
General psychopathology subscale: G15 Preoccupation
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Item
General psychopathology subscale: G16 Active social avoidence
integer
C4086684 (UMLS CUI [1])
Code List
General psychopathology subscale: G16 Active social avoidence
CL Item
1: Absent (1)
CL Item
2: Minimal (2)
CL Item
3: Mild (3)
CL Item
4: Moderate (4)
CL Item
5: Moderate severe (5)
CL Item
6: Severe (6)
CL Item
7: Extreme (7)
Calculated total PANSS score
Item
Calculated total PANSS score
integer
C4086747 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
Item Group
Clinical Global Impression - Severity
C3639708 (UMLS CUI-1)
Rater´s initials
Item
Rater´s initials
text
C3166278 (UMLS CUI [1])
Item
Considering your total clinical experience with this particular population, how severe is the subject's psychotic disorder at this time?
integer
C3698629 (UMLS CUI [1])
Code List
Considering your total clinical experience with this particular population, how severe is the subject's psychotic disorder at this time?
CL Item
normal, not at all ill (1)
CL Item
borderline mentally ill (2)
CL Item
mildly ill (3)
CL Item
moderately ill (4)
CL Item
markedly ill (5)
CL Item
severely ill (6)
CL Item
among the most extremely ill patients (7)

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