ID

42976

Descripción

Study Sponsor: Astellas Study Title Tolerability of QUTENZA™ When Applied After Pre-treatment With Lidocaine or Tramadol in Subjects With Peripheral Neuropathic Pain - A Randomized, Multi-center, Assessor-blinded Study Medicine or Vaccine (generic name) capsaicin Sponsor Identification Number QTZ-EC-0002 Trial Registry Identification Number(#'s) NCT01416116 EudraCT Number: 2010-023258-34 Medical Condition Neuropathic pain Phase Phase 4 http://clinicaltrials.gov/show/NCT01416116 Unscheduled Visit >> Unscheduled Event Physical Examination Vital Signs 12 Lead ECG Laboratory Tests: Hematology

Link

http://clinicaltrials.gov/show/NCT01416116

Palabras clave

Versiones (3)
  1. 27/9/17 27/9/17 -
  2. 27/9/17 27/9/17 -
  3. 17/9/21 17/9/21 -
Subido en

17 de septiembre de 2021

DOI

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Licencia

Creative Commons BY 4.0
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    Unscheduled Visit >> Unscheduled Event Form 1/2 Tolerability of QUTENZA™ When Applied After Pre-treatment With Lidocaine or Tramadol in Subjects With Peripheral Neuropathic Pain - A Randomized, Multi-center, Assessor-blinded Study NCT01416116

    Inglés

    Unscheduled Visit >> Unscheduled Event Form 1/2 Tolerability of QUTENZA™ When Applied After Pre-treatment With Lidocaine or Tramadol in Subjects With Peripheral Neuropathic Pain - A Randomized, Multi-center, Assessor-blinded Study NCT01416116

    1 formularios  
    Physical Examination
    Descripción

    Physical Examination

    Was the Physical Examination performed
    Descripción

    If the Physical Examination was performed, please provide the Assessment Date below.

    Tipo de datos

    integer

    Assessment Date
    Descripción

    Assessment Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C2985720
    Vital Signs
    Descripción

    Vital Signs

    Assessment Date
    Descripción

    Assessment Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C2985720
    Position
    Descripción

    Position

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0733755
    Systolic Blood Pressure
    Descripción

    Systolic Blood Pressure

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0871470
    Diastolic Blood Pressure
    Descripción

    Diastolic Blood Pressure

    Tipo de datos

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Pulse Rate
    Descripción

    Pulse Rate

    Tipo de datos

    integer

    Unidades de medida
    • bpm
    Alias
    UMLS CUI [1]
    C0232117
    bpm
    ECG: 12 Lead ECG
    Descripción

    ECG: 12 Lead ECG

    Date ECG Performed
    Descripción

    Date ECG Performed

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C2826846
    ECG Interpretation
    Descripción

    ECG Interpretation

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1623258
    UMLS CUI [1,2]
    C0459471
    Abnormality Code
    Descripción

    Abnormality Code

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0522055
    Clinically Significant?
    Descripción

    Clinically Significant

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C2826635
    Comment on Abnormal Result (For abnormal code 'Other', Please also specify the abnormality).
    Descripción

    Abnormal Result

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0522055
    Laboratory Tests: Hematology
    Descripción

    Laboratory Tests: Hematology

    Were samples taken?
    Descripción

    samples taken

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C1277698
    Date of Sample Taken
    Descripción

    Date of Sample Taken

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0011008
    LAB Interpretation
    Descripción

    If LAB interpretation is abnormal, please select assessment items below and report the interpretation for each.

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C3244125
    Abnormal Lab tests: Hematology
    Descripción

    Abnormal Lab tests: Hematology

    Lab Tests
    Descripción

    Lab Tests

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0022885
    Lab interpretation
    Descripción

    Lab interpretation

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C3244125
    Laboratory Tests: Biochemistry
    Descripción

    Laboratory Tests: Biochemistry

    Were samples taken?
    Descripción

    Were samples taken?

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C1277698
    Date of Sample Taken
    Descripción

    Date of Sample Taken

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0011008
    LAB Interpretation
    Descripción

    If LAB interpretation is abnormal, please select assessment items below and report the interpretation for each.

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C3244125
    Abnormal Lab tests: Biochemistry
    Descripción

    Abnormal Lab tests: Biochemistry

    Lab Test
    Descripción

    Lab Test

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0022885
    LAB Interpretation
    Descripción

    LAB Interpretation

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C3244125
    Volver a la parte superior de la página

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    Unscheduled Visit >> Unscheduled Event Form 1/2 Tolerability of QUTENZA™ When Applied After Pre-treatment With Lidocaine or Tramadol in Subjects With Peripheral Neuropathic Pain - A Randomized, Multi-center, Assessor-blinded Study NCT01416116

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Physical Examination
    Item
    Was the Physical Examination performed
    integer
    Physical Examination
    Code List
    Was the Physical Examination performed
    CL Item
    No (0)
    CL Item
    Yes (1)
    Assessment Date
    Item
    Assessment Date
    date
    C2985720 (UMLS CUI [1])
    Item Group
    Vital Signs
    Assessment Date
    Item
    Assessment Date
    date
    C2985720 (UMLS CUI [1])
    Item
    Position
    integer
    C0733755 (UMLS CUI [1])
    Position
    Code List
    Position
    CL Item
    Supine (1)
    CL Item
    Sitting (2)
    CL Item
    Standing (3)
    Systolic Blood Pressure
    Item
    Systolic Blood Pressure
    text
    C0871470 (UMLS CUI [1])
    Diastolic Blood Pressure
    Item
    Diastolic Blood Pressure
    integer
    C0428883 (UMLS CUI [1])
    Pulse Rate
    Item
    Pulse Rate
    integer
    C0232117 (UMLS CUI [1])
    Item Group
    ECG: 12 Lead ECG
    Item
    Date ECG Performed
    integer
    C2826846 (UMLS CUI [1])
    Date ECG Performed
    Code List
    Date ECG Performed
    CL Item
    No (0)
    CL Item
    Yes (1)
    Item
    ECG Interpretation
    integer
    C1623258 (UMLS CUI [1,1])
    C0459471 (UMLS CUI [1,2])
    ECG Interpretation
    Code List
    ECG Interpretation
    CL Item
    Normal (1)
    CL Item
    Abnormal - not clinically (2)
    CL Item
    significant (3)
    CL Item
    Abnormal - clinically (4)
    CL Item
    significant (5)
    Item
    Abnormality Code
    integer
    C0522055 (UMLS CUI [1])
    Abnormality Code
    Code List
    Abnormality Code
    CL Item
    Sinus Tachycardia  (1)
    CL Item
    Sinus Bradycardia (2)
    CL Item
    Atrial Tachycardia - Without Block (3)
    CL Item
    Atrial Tachycardia - With Block (4)
    CL Item
    Atrial Flutter (5)
    CL Item
    Atrial Fibrillation (6)
    CL Item
    PSVT(Paroxysmal (7)
    CL Item
    Supraventricular Tachycardia) (8)
    CL Item
    Variable Atrial Pacemaker (9)
    CL Item
    Junctional Rhythm Without (10)
    CL Item
    Aberrancy (11)
    CL Item
    Junctional Rhythm With (12)
    CL Item
    Aberrancy (13)
    CL Item
    Ventricular Rhythm (14)
    CL Item
    Ventricular Tachycardia (15)
    CL Item
    Accelerated AV Conduction (16)
    CL Item
    Pattern (17)
    CL Item
    Wolff - Parkinson - White (18)
    CL Item
    Pattern (19)
    CL Item
    Supraventricular Ectopic Beats (20)
    CL Item
    Ventricular Ectopic Beats –Unifocal (21)
    CL Item
    Ventricular Ectopic Beats -Multifocal (22)
    CL Item
    Pacemaker Rhythm (23)
    CL Item
    Ventricular Fibrillation (24)
    CL Item
    Sinus Arrest (25)
    CL Item
    Sinus Arrhythmia (26)
    CL Item
    Nodal Tachycardia (27)
    CL Item
    LGL Syndrome (28)
    CL Item
    Junctional escape complexes (29)
    CL Item
    Sino - Atrial Block (30)
    CL Item
    First Degree AV Block (31)
    CL Item
    Second Degree AV Block -Mobitz I (32)
    CL Item
    Second Degree AV Block -Mobitz II (33)
    CL Item
    Complete AV Block (34)
    CL Item
    Prolonged QT Interval (35)
    CL Item
    Prolonged QTc interval (36)
    CL Item
    Right Atrial Enlargement (37)
    CL Item
    Left Atrial Enlargement (38)
    CL Item
    P-Wave Abnormality (39)
    CL Item
    AV Dissociation (40)
    CL Item
    Left Anterior Hemiblock (41)
    CL Item
    Left Posterior Hemiblock (42)
    CL Item
    Right Bundle Branch Block (43)
    CL Item
    Incomplete Right Bundle (44)
    CL Item
    Branch Block (45)
    CL Item
    Left Bundle Branch Block (46)
    CL Item
    Incomplete Left Bundle BranchBlock (47)
    CL Item
    Nonspecific Intraventricular (48)
    CL Item
    Conduction Delay (49)
    CL Item
    Bifascicular Block (50)
    CL Item
    Left Axis Deviation (51)
    CL Item
    Right Axis Deviation (52)
    CL Item
    Abnormal QRS Axis (53)
    CL Item
    Left Ventricular Hypertrophia (54)
    CL Item
    Left Ventricular Hypertrophia (55)
    CL Item
    By Voltage Only (56)
    CL Item
    Right Ventricular Hypertrophia (57)
    CL Item
    Old Myocardial Infarction:Antero septal (58)
    CL Item
    Old Myocardial Infarction:Antero lateral (59)
    CL Item
    Old Myocardial Infarction:Infero lateral (60)
    CL Item
    Old Myocardial Infarction:Infero posterior (61)
    CL Item
    Old Myocardial Infarction:Postero lateral (62)
    CL Item
    Old Myocardial Infarction:Lateral (63)
    CL Item
    Low Voltage QRS Complex (64)
    CL Item
    Poor R-Wave Progression (65)
    CL Item
    Late R-Wave Transition (66)
    CL Item
    Early Repolarization - Normal (67)
    CL Item
    Variant (68)
    CL Item
    Early R-Wave Transition (69)
    CL Item
    New Myocardial Infarction:Antero septal (70)
    CL Item
    New Myocardial Infarction:Antero lateral (71)
    CL Item
    New Myocardial Infarction:Infero lateral (72)
    CL Item
    New Myocardial Infarction:Infero posterior (73)
    CL Item
    New Myocardial Infarction:Postero lateral (74)
    CL Item
    New Myocardial Infarction:Lateral (75)
    CL Item
    Myocardial Infarction -Nontransmural -Acute orEvolving (76)
    CL Item
    ST Elevation Consistent with (77)
    CL Item
    Ischaemia: Anterior (78)
    CL Item
    ST Elevation Consistent withIschaemia: Septal (79)
    CL Item
    ST Elevation Consistent withIschaemia: Lateral (80)
    CL Item
    ST Elevation Consistent withIschaemia: Inferior (81)
    CL Item
    ST Elevation Consistent withIschaemia: Posterior (82)
    CL Item
    ST Elevation Consistent withIschaemia:High Lateral (83)
    CL Item
    ST Elevation Consistent With (84)
    CL Item
    Pericarditis (85)
    CL Item
    Non-Specific ST-T Change (86)
    CL Item
    ST-T changes - Consistent WithDrug Effects (87)
    CL Item
    ST Depression: Anterior (88)
    CL Item
    ST Depression: Septal (89)
    CL Item
    ST Depression: Lateral (90)
    CL Item
    ST Depression: Inferior (91)
    CL Item
    ST Depression: Posterior (92)
    CL Item
    ST Depression: High Lateral (93)
    CL Item
    ST Depression - Non-Specific (94)
    CL Item
    95 (95)
    CL Item
    T-Wave Inversion Suggestiveof Non-Q-Wave MI (96)
    CL Item
    T-Wave Flattening or Inversionin Two or More Leads (97)
    CL Item
    Non-Specific T-Wave changes (98)
    CL Item
    T-Wave Inversion Suggestiveof Ischaemia (99)
    CL Item
    T-Wave Peaking (100)
    CL Item
    U-Wave Abnormality (101)
    CL Item
    Other (102)
    Item
    Clinically Significant?
    integer
    C2826635 (UMLS CUI [1])
    Clinically Significant
    Code List
    Clinically Significant?
    CL Item
    Yes (0)
    CL Item
    No (1)
    Abnormal Result
    Item
    Comment on Abnormal Result (For abnormal code 'Other', Please also specify the abnormality).
    text
    C0522055 (UMLS CUI [1])
    Item Group
    Laboratory Tests: Hematology
    Item
    Were samples taken?
    integer
    C1277698 (UMLS CUI [1])
    samples taken
    Code List
    Were samples taken?
    CL Item
    No (0)
    CL Item
    Yes (1)
    Date of Sample Taken
    Item
    Date of Sample Taken
    date
    C0005834 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    LAB Interpretation
    integer
    C3244125 (UMLS CUI [1])
    LAB Interpretation
    Code List
    LAB Interpretation
    CL Item
    Normal  (1)
    CL Item
    Abnormal (2)
    Item Group
    Abnormal Lab tests: Hematology
    Item
    Lab Tests
    integer
    C0022885 (UMLS CUI [1])
    Lab Tests
    Code List
    Lab Tests
    CL Item
    Red Blood Cell Count 5 (1)
    CL Item
    White Blood Cell Count (2)
    CL Item
    Lymphocytes (3)
    CL Item
    Neutrophils (4)
    CL Item
    Eosinophils (5)
    CL Item
    Basophils (6)
    CL Item
    Monocytes (7)
    CL Item
    Hemoglobin (8)
    CL Item
    Hematocrit (9)
    CL Item
    Platelets (10)
    Item
    Lab interpretation
    integer
    C3244125 (UMLS CUI [1])
    Lab interpretation
    Code List
    Lab interpretation
    CL Item
    Abnormal - not clinically significant (1)
    CL Item
    Abnormal - clinically significant (2)
    Item Group
    Laboratory Tests: Biochemistry
    Item
    Were samples taken?
    integer
    C1277698 (UMLS CUI [1])
    Were samples taken?
    Code List
    Were samples taken?
    CL Item
    No (0)
    CL Item
    Yes (1)
    Date of Sample Taken
    Item
    Date of Sample Taken
    date
    C0005834 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    LAB Interpretation
    integer
    C3244125 (UMLS CUI [1])
    LAB Interpretation
    Code List
    LAB Interpretation
    CL Item
    Normal (1)
    CL Item
    Abnormal (2)
    Item Group
    Abnormal Lab tests: Biochemistry
    Item
    Lab Test
    integer
    C0022885 (UMLS CUI [1])
    Lab Test
    Code List
    Lab Test
    CL Item
    AST (1)
    CL Item
    ALT (2)
    CL Item
    Alkaline Phosphatase (3)
    CL Item
    Chloride (4)
    CL Item
    Sodium (5)
    CL Item
    Potassium (6)
    CL Item
    Blood urea nitrogen (7)
    CL Item
    Creatinine (8)
    Item
    LAB Interpretation
    integer
    C3244125 (UMLS CUI [1])
    LAB Interpretation
    Code List
    LAB Interpretation
    CL Item
    Abnormal - not clinically significant (1)
    CL Item
    Abnormal - clinically significant (2)
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