ID

42976

Description

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

Keywords

Versions (3)
  1. 9/27/17 9/27/17 -
  2. 9/27/17 9/27/17 -
  3. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

DOI

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License

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

English

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 forms  
Physical Examination
Description

Physical Examination

Was the Physical Examination performed
Description

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

Data type

integer

Assessment Date
Description

Assessment Date

Data type

date

Alias
UMLS CUI [1]
C2985720
Vital Signs
Description

Vital Signs

Assessment Date
Description

Assessment Date

Data type

date

Alias
UMLS CUI [1]
C2985720
Position
Description

Position

Data type

integer

Alias
UMLS CUI [1]
C0733755
Systolic Blood Pressure
Description

Systolic Blood Pressure

Data type

text

Alias
UMLS CUI [1]
C0871470
Diastolic Blood Pressure
Description

Diastolic Blood Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Pulse Rate
Description

Pulse Rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0232117
bpm
ECG: 12 Lead ECG
Description

ECG: 12 Lead ECG

Date ECG Performed
Description

Date ECG Performed

Data type

integer

Alias
UMLS CUI [1]
C2826846
ECG Interpretation
Description

ECG Interpretation

Data type

integer

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

Abnormality Code

Data type

integer

Alias
UMLS CUI [1]
C0522055
Clinically Significant?
Description

Clinically Significant

Data type

integer

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

Abnormal Result

Data type

text

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

Laboratory Tests: Hematology

Were samples taken?
Description

samples taken

Data type

integer

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

Date of Sample Taken

Data type

date

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

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

Data type

integer

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

Abnormal Lab tests: Hematology

Lab Tests
Description

Lab Tests

Data type

integer

Alias
UMLS CUI [1]
C0022885
Lab interpretation
Description

Lab interpretation

Data type

integer

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

Laboratory Tests: Biochemistry

Were samples taken?
Description

Were samples taken?

Data type

integer

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

Date of Sample Taken

Data type

date

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

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

Data type

integer

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

Abnormal Lab tests: Biochemistry

Lab Test
Description

Lab Test

Data type

integer

Alias
UMLS CUI [1]
C0022885
LAB Interpretation
Description

LAB Interpretation

Data type

integer

Alias
UMLS CUI [1]
C3244125
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Similar models

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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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