ID

42661

Beschreibung

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 Screening Visit Form 2/4: Primary Diagnosis Physical Examination Vital Signs Height and Weight ECG: 12 Lead ECG

Link

http://clinicaltrials.gov/show/NCT01416116

Stichworte

Versionen (3)
  1. 21.07.16 21.07.16 -
  2. 23.07.16 23.07.16 -
  3. 17.09.21 17.09.21 -
Hochgeladen am

17. September 2021

DOI

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Screening Visit Form 2/4 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

Englisch

Screening Visit Form 2/4 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 Formulare  
Primary Diagnosis: Old diagnosis fields
Beschreibung

Primary Diagnosis: Old diagnosis fields

Diagnosis
Beschreibung

Diagnosis

Datentyp

integer

Alias
UMLS CUI [1]
C0011900
Category
Beschreibung

Diagnosis Category

Datentyp

integer

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0683312
Primary Diagnosis: New diagnosis fields
Beschreibung

Primary Diagnosis: New diagnosis fields

Diagnosis
Beschreibung

Diagnosis

Datentyp

text

Alias
UMLS CUI [1]
C0011900
Diagnosis Date
Beschreibung

Diagnosis Date

Datentyp

date

Alias
UMLS CUI [1]
C2316983
Category
Beschreibung

Category

Datentyp

integer

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0683312
If 'Other', specify
Beschreibung

Other

Datentyp

text

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0205394
Physical Examination
Beschreibung

Physical Examination

Was the Physical Examination performed?
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1]
C0031809
Assessment Date
Beschreibung

Record any clinically significant abnormal findings/conditions identified during the exam on the Medical and Surgical History and/or Adverse Events form.

Datentyp

date

Alias
UMLS CUI [1]
C2826643
Vital Signs
Beschreibung

Vital Signs

Assessment Date
Beschreibung

vital signs date

Datentyp

date

Alias
UMLS CUI [1]
C2826644
Position
Beschreibung

Position

Datentyp

integer

Systolic Blood Pressure
Beschreibung

Systolic Blood Pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Beschreibung

Diastolic Blood Pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Pulse Rate
Beschreibung

Pulse Rate

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1]
C0232117
bpm
Height and Weight
Beschreibung

Height and Weight

Assessment Date
Beschreibung

Height and Weight Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0005890
UMLS CUI [1,2]
C0005910
UMLS CUI [1,3]
C0011008
Height
Beschreibung

Height

Datentyp

integer

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
ECG: 12 Lead ECG
Beschreibung

ECG: 12 Lead ECG

Date ECG Performed
Beschreibung

Date ECG Performed

Datentyp

date

Alias
UMLS CUI [1]
C2826846
ECG Interpretation
Beschreibung

ECG Interpretation

Datentyp

integer

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

ECG Abnormality

Datentyp

integer

Alias
UMLS CUI [1]
C0522055
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Ähnliche Modelle

Screening Visit Form 2/4 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 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Primary Diagnosis: Old diagnosis fields
Item
Diagnosis
integer
C0011900 (UMLS CUI [1])
Diagnosis
Code List
Diagnosis
CL Item
Postherpetic Neuralgia (1 )
CL Item
Post Traumatic Peripheral Neuropathic Pain Syndrome (2 )
Item
Category
integer
C0011900 (UMLS CUI [1,1])
C0683312 (UMLS CUI [1,2])
Diagnosis Category
Code List
Category
CL Item
Post-surgical (1 )
CL Item
Peripheral Nerve Injury (2 )
CL Item
Other (99 )
Item Group
Primary Diagnosis: New diagnosis fields
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Diagnosis Date
Item
Diagnosis Date
date
C2316983 (UMLS CUI [1])
Item
Category
integer
C0011900 (UMLS CUI [1,1])
C0683312 (UMLS CUI [1,2])
Category
Code List
Category
CL Item
Post-traumatic (1 )
CL Item
Post-surgical (2 )
CL Item
Other (99)
Other
Item
If 'Other', specify
text
C0011900 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item Group
Physical Examination
Item
Was the Physical Examination performed?
text
C0031809 (UMLS CUI [1])
Physical Examination
Code List
Was the Physical Examination performed?
CL Item
No (0 )
CL Item
Yes (1 )
Physical Examination Date
Item
Assessment Date
date
C2826643 (UMLS CUI [1])
Item Group
Vital Signs
vital signs date
Item
Assessment Date
date
C2826644 (UMLS CUI [1])
Item
Position
integer
Position
Code List
Position
CL Item
Supine (1 )
CL Item
Sitting (2 )
CL Item
Standing (3 )
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
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
Height and Weight
Height and Weight Date
Item
Assessment Date
date
C0005890 (UMLS CUI [1,1])
C0005910 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
ECG: 12 Lead ECG
Date ECG Performed
Item
Date ECG Performed
date
C2826846 (UMLS CUI [1])
Item
ECG Interpretation
integer
C1623258 (UMLS CUI [1,1])
C0459471 (UMLS CUI [1,2])
ECG Interpretation
Code List
ECG Interpretation
CL Item
Normal (0 )
CL Item
Abnormal - not clinically significant (1 )
CL Item
Abnormal - clinically significant (2 )
Item
Abnormality Code
integer
C0522055 (UMLS CUI [1])
ECG Abnormality
Code List
Abnormality Code
CL Item
Sinus Tachycardia (101 )
CL Item
Sinus Bradycardia (102 )
CL Item
Atrial tachycardia - Without Block (103 )
CL Item
Atrial Tachycardia - With Block (104 )
CL Item
Atrial Flutter (105 )
CL Item
Atrial Fibrillation (106 )
CL Item
PSVT(Paroxy smal Supraventricul ar Tachycardia) (107 )
CL Item
Variable Atrial Pacemaker (108 )
CL Item
Junctional Rhythm Without Aberrancy (109 )
CL Item
Junctional Rhythm With Aberrancy (110 )
CL Item
Ventricular Rhythm (111 )
CL Item
Ventricular Tachycardia (112 )
CL Item
Accelerated AV Conduction Pattern (113 )
CL Item
Wolff - Parkinson - White Pattern (114 )
CL Item
Supraventricular Ectopic Beats (115 )
CL Item
Ventricular Ectopic Beats – Unifocal (116 )
CL Item
Ventricular Ectopic Beats - Multifocal (117 )
CL Item
Pacemaker Rhythm (118 )
CL Item
Ventricular Fibrillation (119 )
CL Item
Sinus Arrest (120 )
CL Item
SinusArrhythmia (121 )
CL Item
Nodal Tachycardia (122 )
CL Item
LGL Syndrome (123 )
CL Item
Junctional escape complexes (124 )
CL Item
Sino - Atrial Block (125 )
CL Item
First Degree AV Block (301 )
CL Item
Second Degree AV Block - Mobitz I (302 )
CL Item
Second Degree AV Block - Mobitz II (303 )
CL Item
Complete AV Block (304 )
CL Item
Prolonged QT Interval (401 )
CL Item
Prolonged QTc interval (402 )
CL Item
Right Atrial Enlargement (601 )
CL Item
Left Atrial Enlargement (602 )
CL Item
P-Wave Abnormality (603 )
CL Item
AV Dissociation (701 )
CL Item
Left Anterior Hemiblock (702 )
CL Item
Left Posterior Hemiblock (703 )
CL Item
Right Bundle Branch Block (704 )
CL Item
Incomplete Right Bundle Branch Block (705 )
CL Item
Left Bundle Branch Block (706 )
CL Item
Incomplete Left Bundle Branch Block (707 )
CL Item
Nonspecific Intraventricula r Conduction Delay (708 )
CL Item
Bifascicular Block (709 )
CL Item
Left Axis Deviation (710 )
CL Item
Right Axis Deviation (711 )
CL Item
Abnormal QRS Axis (712 )
CL Item
Left Ventricular Hypertrophia (713 )
CL Item
Left Ventricular Hypertrophia By Voltage Only (714 )
CL Item
Right Ventricular Hypertrophia (715 )
CL Item
Old Myocardial Infarction: Antero septal (716 )
CL Item
Old Myocardial Infarction: Antero lateral (717 )
CL Item
Old Myocardial Infarction: Infero lateral (718 )
CL Item
Old Myocardial Infarction: Infero posterior (719 )
CL Item
Old Myocardial Infarction: Postero lateral (720 )
CL Item
Old Myocardial Infarction: Lateral (721 )
CL Item
Low Voltage QRS Complex (722 )
CL Item
Poor R-Wave Progression (723 )
CL Item
Late R-Wave Transition (724 )
CL Item
Early Repolarization – Normal Variant (725 )
CL Item
Early R-Wave Transition (726 )
CL Item
New Myocardial Infarction: Antero septal (801 )
CL Item
New Myocardial Infarction: Antero lateral (802 )
CL Item
New Myocardial Infarction: Infero lateral (803 )
CL Item
New Myocardial Infarction: Infero posterior (804 )
CL Item
New Myocardial Infarction: Postero lateral (805 )
CL Item
New Myocardial Infarction: Lateral (806 )
CL Item
Myocardial Infarction – Nontransmural -Acute or Evolving (807 )
CL Item
ST Elevation Consistent with Ischaemia: Anterior  (808 )
CL Item
ST Elevation Consistent with Ischaemia: Septal  (809 )
CL Item
ST Elevation Consistent with Ischaemia: Lateral (810 )
CL Item
ST Elevation Consistent with Ischaemia: Inferior (811 )
CL Item
ST Elevation Consistent with Ischaemia: Posterior (812 )
CL Item
ST Elevation Consistent with Ischaemia:High Lateral (813 )
CL Item
ST Elevation Consistent With Pericarditis (814 )
CL Item
Non-Specific ST-T Change (815 )
CL Item
ST-T changes - Consistent With Drug Effects (816 )
CL Item
ST Depression: Anterior (817 )
CL Item
ST Depression: Septal (818 )
CL Item
ST Depression: Lateral (819 )
CL Item
ST Depression: Inferior (820 )
CL Item
ST Depression: Posterior (821 )
CL Item
ST Depression: High Lateral (822 )
CL Item
ST Depression - Non-Specific (823 )
CL Item
T-Wave Inversion Suggestive of Non-Q-Wave MI (901 )
CL Item
T-Wave Flattening or Inversion in Two or More Leads (902 )
CL Item
Non-Specific T-Wave changes (903 )
CL Item
T-Wave Inversion Suggestive of Ischaemia (904 )
CL Item
T-Wave Peaking 998 = U-Wave Abnormality (905 )
CL Item
Other (999 )
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