Información:
Error:
ID
22227
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
Versiones (1)
- 23/5/17 23/5/17 -
Subido en
23 de mayo de 2017
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY 4.0
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Unscheduled Visit - CRFs Paliperidone Palmitate Schizophrenia NCT01515423
Unscheduled Visit - CRFs Paliperidone Palmitate Schizophrenia NCT01515423
Similar models
Unscheduled Visit - CRFs Paliperidone Palmitate Schizophrenia NCT01515423
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Date of visit
Item
Visit date
date
C1320303 (UMLS CUI [1])
ECG reference number
Item
ECG reference number
integer
C1623258 (UMLS CUI [1,1])
C3274661 (UMLS CUI [1,2])
C3274661 (UMLS CUI [1,2])
Weight
Item
Body Weight
float
C0005910 (UMLS CUI [1])
Waist Circumference
Item
Waist Circumference
float
C0455829 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0039476 (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)
Item Group
PK Blood Sample: Paliperidone
C0201734 (UMLS CUI-1)
C0178913 (UMLS CUI-2)
C0753678 (UMLS CUI-3)
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])
C2826726 (UMLS CUI [1,2])
Comment, blood specimen
Item
Specimen comments, if any
text
C0947611 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,2])
Accession number
Item
Accession number
integer
C1510755 (UMLS CUI [1,1])
C2826726 (UMLS CUI [1,2])
C2826726 (UMLS CUI [1,2])
Item
Was the Dipstick Pregnancy Test performed?
integer
C0430056 (UMLS CUI [1])
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (postmenopausal females) (3)
Reason for no pregnancy test
Item
If No, please provide a reason:
text
C0566251 (UMLS CUI [1,1])
C3841220 (UMLS CUI [1,2])
C0032976 (UMLS CUI [1,3])
C3841220 (UMLS CUI [1,2])
C0032976 (UMLS CUI [1,3])
CL Item
Positive (1)
CL Item
Negative (2)
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) Since Last Visit Version
C3641328 (UMLS CUI-1)
SSRS: Wish to be dead
Item
Suicidal Ideation: Wish to be dead
boolean
C3641578 (UMLS CUI [1])
SSRS: Description of wish to be dead
Item
Suicidal Ideation: If ´Yes´, describe:
text
C3641579 (UMLS CUI [1])
SSRS: Non-specific active suicidal thoughts
Item
Suicidal Ideation: Non-specific active suicidal thoughts
boolean
C3641580 (UMLS CUI [1])
SSRS: Description of Non-Specific Active Suicidal Thoughts
Item
Suicidal Ideation: If ´Yes´, describe:
text
C3641581 (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
C3641582 (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
C3641583 (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
C3641605 (UMLS CUI [1])
SSRS: Description of Active Suicidal Ideation with Some Intent to Act, without Specific Plan
Item
Suicidal Ideation: If ´Yes´, describe:
text
C3641606 (UMLS CUI [1])
SSRS: Active suicidal ideation with specific plan and intent
Item
Suicidal Ideation: Active suicidal ideation with specific plan and intent
boolean
C3641607 (UMLS CUI [1])
SSRS: Description of Active Suicidal Ideation with Specific Plan and Intent
Item
Suicidal Ideation: If ´Yes´, describe:
text
C3641584 (UMLS CUI [1])
Item
Intensity of Ideation: Most Severe Ideation
integer
C3641585 (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
C3641586 (UMLS CUI [1])
Item
Intensity of Ideation: Frequency of Most Severe Ideation
integer
C3641587 (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
C3641588 (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
C3641589 (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
C3641590 (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
C3641591 (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
C3641592 (UMLS CUI [1])
SSRS: Number of Actual Suicide Attempts
Item
Suicidal Behavior: If ´Yes´, specify total number of attempts:
integer
C3641593 (UMLS CUI [1])
SSRS: Description of Actual Suicide Attempts
Item
Suicidal Behavior: If ´Yes´, describe:
text
C3641594 (UMLS CUI [1])
SSRS: Non-suicidal self-injurious behavior
Item
Suicidal Behavior: Non-suicidal self-injurious behavior
boolean
C3641595 (UMLS CUI [1])
SSRS: Interrupted Suicide Attempt
Item
Suicidal Behavior: Interrupted attempt
boolean
C3641596 (UMLS CUI [1])
SSRS: Number of Interrupted Suicide Attempts
Item
Suicidal Behavior: If ´Yes´, specify total number of interrupted attempts:
integer
C3641597 (UMLS CUI [1])
SSRS: Description of Interrupted Suicide Attempts
Item
Suicidal Behavior: If ´Yes´, describe:
text
C3641598 (UMLS CUI [1])
SSRS: Aborted Suicide Attempt
Item
Suicidal Behavior: Aborted attempt
boolean
C3641599 (UMLS CUI [1])
SSRS: Number of Aborted Suicide Attempts
Item
Suicidal Behavior: If ´Yes´, specify total number of aborted attempts:
integer
C3641600 (UMLS CUI [1])
SSRS: Description of Aborted Suicide Attempt
Item
Suicidal Behavior: If ´Yes´, describe:
text
C3641601 (UMLS CUI [1])
SSRS: Preparatory Acts or Behaviors Toward Suicide Attempt
Item
Suicidal Behavior: Preparatory acts or behavior toward suicide attempt
boolean
C3641602 (UMLS CUI [1])
SSRS: Description of Preparatory Acts or Behaviors Toward Suicide Attempt
Item
Suicidal Behavior: If ´Yes´, describe:
text
C3641603 (UMLS CUI [1])
SSRS: Suicidal Behavior
Item
Suicidal Behavior
boolean
C3641604 (UMLS CUI [1])
SSRS: Completed suicide
Item
Completed suicide
boolean
C3641338 (UMLS CUI [1])
SSRS: Most Lethal Suicide Attempt Date
Item
Suicidal Behavior - Actual Attempts: Most lethal attempt date
date
C3641339 (UMLS CUI [1])
Item
Suicidal Behavior - Actual Attempts: Most Lethal Suicide Attempt actual lethality/medical damage
integer
C3641340 (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
C3641341 (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)
Item Group
Investigator Evaluation of lnjection site
C0035173 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
C2700396 (UMLS CUI-3)
C0220825 (UMLS CUI-2)
C2700396 (UMLS CUI-3)
Rater's initials
Item
Rater's initials
text
C3166278 (UMLS CUI [1])
Time of evaluation
Item
Time of evaluation
time
C0040223 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0220825 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
CL Item
Absent (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Item
Swelling
integer
C0038999 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,2])
CL Item
Absent (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Item
Induration
integer
C0332534 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,2])
CL Item
Absent (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Item Group
Subject Evaluation of lnjection site
C0030705 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
C2700396 (UMLS CUI-3)
C0220825 (UMLS CUI-2)
C2700396 (UMLS CUI-3)
Time of evaluation
Item
Time of evaluation
time
C0040223 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0220825 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Injection pain
Item
Injection pain
boolean
C0151828 (UMLS CUI [1])
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])
Item Group
Mini Positive and Negative Syndrome Scale for Schizophrenia
C1282927 (UMLS CUI-1)
C4086747 (UMLS CUI-2)
C0036341 (UMLS CUI-3)
C4086747 (UMLS CUI-2)
C0036341 (UMLS CUI-3)
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)
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)
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 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)
Item Group
Personal and Social Performance Scale
C0450973 (UMLS CUI-1)
C0037397 (UMLS CUI-2)
C0037397 (UMLS CUI-2)
Rater's initials
Item
Rater's initials
text
C3166278 (UMLS CUI [1])
Item
Domain of functioning: Socially useful activities, including work and study
integer
C3641834 (UMLS CUI [1])
Code List
Domain of functioning: Socially useful activities, including work and study
CL Item
1 Absent (1)
CL Item
2 Mild (2)
CL Item
3 Manifest (3)
CL Item
4 Marked (4)
CL Item
5 Severe (5)
CL Item
6 Very Severe (6)
Item
Domain of functioning: Personal and social relationships
integer
C0021797 (UMLS CUI [1])
CL Item
1 Absent (1)
CL Item
2 Mild (2)
CL Item
3 Manifest (3)
CL Item
4 Marked (4)
CL Item
5 Severe (5)
CL Item
6 Very Severe (6)
CL Item
1 Absent (1)
CL Item
2 Mild (2)
CL Item
3 Manifest (3)
CL Item
4 Marked (4)
CL Item
5 Severe (5)
CL Item
6 Very Severe (6)
Item
Domain of functioning: Disturbing and aggressive behaviors
integer
C0001807 (UMLS CUI [1])
Code List
Domain of functioning: Disturbing and aggressive behaviors
CL Item
1 Absent (1)
CL Item
2 Mild (2)
CL Item
3 Manifest (3)
CL Item
4 Marked (4)
CL Item
5 Severe (5)
CL Item
6 Very Severe (6)
Total score
Item
Total score
integer
C2964552 (UMLS CUI [1])
Psychiatric hospitalization
Item
1.Since the last visit, has the subject had a psychiatric hospitalization (involuntary or voluntary admission to a psychiatric hospital for decompensation of the subject´s schizophrenic symptoms)
boolean
C0748061 (UMLS CUI [1])
Psychiatric hospitalization date
Item
If `yes`, please enter date of psychiatric hospitalization:
date
C0748061 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Worsening of schizophrenic symptoms, PANSS
Item
2.Worsening: A. An increase of >= 25% in total PANSS score from randomization if the score at randomization was >40.
boolean
C0036341 (UMLS CUI [1,1])
C1546960 (UMLS CUI [1,2])
C4086747 (UMLS CUI [1,3])
C1546960 (UMLS CUI [1,2])
C4086747 (UMLS CUI [1,3])
Date, worsening of schizophrenic symptoms
Item
If `yes`, please enter date:
date
C0011008 (UMLS CUI [1,1])
C0036341 (UMLS CUI [1,2])
C1546960 (UMLS CUI [1,3])
C0036341 (UMLS CUI [1,2])
C1546960 (UMLS CUI [1,3])
Worsening of schizophrenic symptoms, PANSS
Item
2.Worsening: B. A 10 point increase in total PANSS score from randomization if the score at randomization was <= 40
boolean
C0036341 (UMLS CUI [1,1])
C1546960 (UMLS CUI [1,2])
C4086747 (UMLS CUI [1,3])
C1546960 (UMLS CUI [1,2])
C4086747 (UMLS CUI [1,3])
Date, worsening of schizophrenic symptoms
Item
If `yes`, please enter date:
date
C0011008 (UMLS CUI [1,1])
C0036341 (UMLS CUI [1,2])
C1546960 (UMLS CUI [1,3])
C0036341 (UMLS CUI [1,2])
C1546960 (UMLS CUI [1,3])
Self-injury, physical aggression
Item
3.Since the last visit, has the subject had a deliberate self-injury or exhibited violent behavior resulting in suicide, clinically significant injury to him/her self or another person or significant property damage?
boolean
C0178360 (UMLS CUI [1,1])
C0424323 (UMLS CUI [1,2])
C0424323 (UMLS CUI [1,2])
Date of self-injury or physical aggression
Item
If `yes`, please enter date of event:
date
C0011008 (UMLS CUI [1,1])
C0178360 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0424323 (UMLS CUI [1,4])
C0178360 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0424323 (UMLS CUI [1,4])
Item
If `yes`, describe the event:
integer
C2348235 (UMLS CUI [1,1])
C0178360 (UMLS CUI [1,2])
C0424323 (UMLS CUI [1,3])
C0178360 (UMLS CUI [1,2])
C0424323 (UMLS CUI [1,3])
CL Item
Deliberate self-injury (1)
CL Item
Violent behavior resulting in suicide, injury or property damage (2)
Suicidal or homicidal ideation, aggressive behavior
Item
4.Since the last visit, has the subject had a suicidal or homicidal ideation and aggressive behavior that was clinically significant (in frequency and severity) in the investigator´s judgment?
boolean
C0749133 (UMLS CUI [1,1])
C0455204 (UMLS CUI [1,2])
C0001807 (UMLS CUI [1,3])
C0455204 (UMLS CUI [1,2])
C0001807 (UMLS CUI [1,3])
Date of suicidal or homicidal ideation, aggressive behavior
Item
If `yes`, please enter date of event:
date
C0011008 (UMLS CUI [1,1])
C0749133 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0455204 (UMLS CUI [1,4])
C0011008 (UMLS CUI [1,5])
C0001807 (UMLS CUI [1,6])
C0749133 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0455204 (UMLS CUI [1,4])
C0011008 (UMLS CUI [1,5])
C0001807 (UMLS CUI [1,6])
Item
If `yes`, describe the event:
integer
C2348235 (UMLS CUI [1,1])
C0749133 (UMLS CUI [1,2])
C0455204 (UMLS CUI [1,3])
C0001807 (UMLS CUI [1,4])
C0749133 (UMLS CUI [1,2])
C0455204 (UMLS CUI [1,3])
C0001807 (UMLS CUI [1,4])
Code List
If `yes`, describe the event:
CL Item
Suicide attempt (1)
CL Item
Suicidal ideation (2)
CL Item
Homicidal ideation (3)
Worsening of schizophrenic symptoms, PANSS
Item
5.Worsening of any one of the following PANSS items: P1 (delusions), P2 (conceptual disorganization), P3 (hallucinatory behavior), P6 (suspiciousness/persecution), P7 (hostility) or G8 (uncooperativeness) to: A. A score of >= 5 after randomization on any of the above PANSS items if the maximum score for the above PANSS items was <= 3 at randomization
boolean
C0036341 (UMLS CUI [1,1])
C1546960 (UMLS CUI [1,2])
C4086747 (UMLS CUI [1,3])
C1546960 (UMLS CUI [1,2])
C4086747 (UMLS CUI [1,3])
Date, worsening of schizophrenic symptoms
Item
If `yes`, please enter date:
date
C0011008 (UMLS CUI [1,1])
C0036341 (UMLS CUI [1,2])
C1546960 (UMLS CUI [1,3])
C0036341 (UMLS CUI [1,2])
C1546960 (UMLS CUI [1,3])
Worsening of schizophrenic symptoms, PANSS
Item
5.Worsening of any one of the following PANSS items: P1 (delusions), P2 (conceptual disorganization), P3 (hallucinatory behavior), P6 (suspiciousness/persecution), P7 (hostility) or G8 (uncooperativeness) to: B. A score of >= 6 after randomization on any of the above PANSS items if the maximum score for the above PANSS items was = 4 at randomization
boolean
C0036341 (UMLS CUI [1,1])
C1546960 (UMLS CUI [1,2])
C4086747 (UMLS CUI [1,3])
C1546960 (UMLS CUI [1,2])
C4086747 (UMLS CUI [1,3])
Date, worsening of schizophrenic symptoms
Item
If `yes`, please enter date:
date
C0011008 (UMLS CUI [1,1])
C0036341 (UMLS CUI [1,2])
C1546960 (UMLS CUI [1,3])
C0036341 (UMLS CUI [1,2])
C1546960 (UMLS CUI [1,3])
Item Group
Unscheduled Forms: Please select assessments performed at this unscheduled visit
C3854240 (UMLS CUI-1)
C0376315 (UMLS CUI-2)
C0376315 (UMLS CUI-2)
PK Blood Sample
Item
PK Blood Sample
boolean
C0201734 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,2])
Positive and Negative Syndrome Scale for Schizophrenia
Item
Positive and Negative Syndrome Scale for Schizophrenia
boolean
C4086747 (UMLS CUI [1,1])
C0036341 (UMLS CUI [1,2])
C0036341 (UMLS CUI [1,2])
Simpson Angus Rating Scale
Item
Simpson Angus Rating Scale
boolean
C0030569 (UMLS CUI [1,1])
C0450973 (UMLS CUI [1,2])
C0450973 (UMLS CUI [1,2])
Abnormal Involuntary Movement Scale
Item
Abnormal Involuntary Movement Scale
boolean
C0450978 (UMLS CUI [1])
Barnes Akathisia Rating Scale
Item
Barnes Akathisia Rating Scale
boolean
C3541345 (UMLS CUI [1])
Personal and Social Performance Scale
Item
Personal and Social Performance Scale
boolean
C0450973 (UMLS CUI [1,1])
C0037397 (UMLS CUI [1,2])
C0037397 (UMLS CUI [1,2])
Evaluation of Relapse
Item
Evaluation of Relapse
boolean
C0220825 (UMLS CUI [1,1])
C0035020 (UMLS CUI [1,2])
C0035020 (UMLS CUI [1,2])
Vital Signs with Weight, Waist and Temperature
Item
Vital Signs with Weight, Waist and Temperature
boolean
C0518766 (UMLS CUI [1])
Urine Dipstick Pregnancy Test
Item
Urine Dipstick Pregnancy Test
boolean
C0430056 (UMLS CUI [1])
Clinical Global Impression - Severity
Item
Clinical Global Impression - Severity
boolean
C3639708 (UMLS CUI [1])
Mini Positive and Negative Syndrome Scale for Schizophrenia
Item
Mini-Positive and Negative Syndrome Scale for Schizophrenia
boolean
C1282927 (UMLS CUI [1,1])
C4086747 (UMLS CUI [1,2])
C0036341 (UMLS CUI [1,3])
C4086747 (UMLS CUI [1,2])
C0036341 (UMLS CUI [1,3])
Columbia - Suicide Severity Rating Scale (C-SSRS) Since Last Visit
Item
Columbia - Suicide Severity Rating Scale (C-SSRS) Since Last Visit
boolean
C3641328 (UMLS CUI [1])
Investigator Evaluation of Injection site
Item
Investigator Evaluation of Injection site
boolean
C0035173 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0220825 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Subject Evaluation of Injection site
Item
Subject Evaluation of Injection site
boolean
C0030705 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0220825 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Lab Sample Central Lab
Item
Lab Sample Central Lab
boolean
C3244292 (UMLS CUI [1])
ECG
Item
ECG
boolean
C1623258 (UMLS CUI [1])