ID

38141

Descripción

Study ID: 111539 Clinical Study ID: 111539 Study Title: A Single-Blind Study of the Safety, Pharmacokinetics and Pharmacodynamics of scalating Repeat Doses of GSK249320 in Patients With Stroke Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00833989 https://clinicaltrials.gov/ct2/show/NCT00833989 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Refanezumab, Placebo Trade Name: N/A Study Indication: Ischaemic Attack, Transient The study consists of 8 visits: Day 1, Week 1 (Day 5), Week 2 (Day 10), Week 4 (Day 30), Week 8 (Day 60), Week 12 (Day 90), Week 16 (Day 112), Follow-up (F/U). All subjects will receive two doses. The first dose within 24-72 hrs after stroke the second dose 9 +/- 1 days after the first one. Each dose will be given as an intravenous infusion over 60 minutes. This document contains the SAE form. It has to be filled in if a SAE occurs during the study.

Link

https://clinicaltrials.gov/ct2/show/NCT00833989

Palabras clave

Versiones (3)
  1. 22/9/19 22/9/19 -
  2. 5/10/19 5/10/19 -
  3. 24/10/19 24/10/19 - Sarah Riepenhausen
Titular de derechos de autor

GlaxoSmithKline

Subido en

22 de septiembre de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
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Safety, Pharmacokinetics and Pharmacodynamics of Refanezumab in Patients with Stroke, 111539

Inglés

Serious Adverse Event

1 formularios  
  1. StudyEvent: ODM
    1. Serious Adverse Event
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Descripción

Subject Number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Serious adverse events
Descripción

Serious adverse events

Alias
UMLS CUI-1
C1519255
Type of report
Descripción

Type of report

Tipo de datos

integer

Alias
UMLS CUI [1]
C0585733
Did SAE occur after initiation of study medication?
Descripción

SAE occurrence

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2745955
UMLS CUI [1,2]
C1519255
Serious Adverse Event
Descripción

Diagnosis Only (if known) Otherwise Sign/Symptom

Tipo de datos

text

Alias
UMLS CUI [1]
C1519255
Start Date of SAE
Descripción

day month year

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1519255
Outcome of SAE
Descripción

If you tick "Recovered/Resolved"or "Recovered/Resolved with sequelae", provide End Date and Time in the following items. If you tick "Fatal", record Date of Death in the following item.

Tipo de datos

integer

End Date of SAE/Date of Death
Descripción

day month year

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1519255
UMLS CUI [2]
C1148348
End Time of SAE
Descripción

00:00-23:59

Tipo de datos

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C1519255
Maximum Intensity
Descripción

Maximum Intensity

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C1519255
Action Taken with Investigational Product(s) as a Result of the AE
Descripción

Action Taken with Investigational Product(s) as a Result of the AE

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1519255
Did the subject withdraw from study as a result of this AE?
Descripción

Withdrawal as result of SAE

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C1519255
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Descripción

Relationship between SAE and investigational product

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0439849
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C1519255
Was SAE caused by activities related to study participation (e.g. procedures)?
Descripción

Relationship between SAE to study participation

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0439849
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C2348568
Seriousness
Descripción

Seriousness

Alias
UMLS CUI-1
C1710056
Specify the reason for considering this an SAE. Check all that apply. Results in death
Descripción

Results in death

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0011065
Specify the reason for considering this an SAE. Check all that apply. Life-threatening
Descripción

Life-threatening

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1517874
Specify the reason for considering this an SAE. Check all that apply. Requires hospitalisation or prolongation of existing hospitalisation
Descripción

Requires hospitalisation or prolongation of existing hospitalisation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0019993
UMLS CUI [1,3]
C0745041
Specify the reason for considering this an SAE. Check all that apply. Results in disability/incapacity
Descripción

Results in disability/incapacity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0231170
Specify the reason for considering this an SAE. Check all that apply. Congenital anomaly/birth defect
Descripción

Congenital anomaly/birth defect

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0000768
Specify the reason for considering this an SAE. Check all that apply. Other
Descripción

Other reason

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C3840932
If other reason, please specify
Descripción

Other reason, specification

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C3840932
UMLS CUI [1,3]
C2348235
Relevant Concomitant/treatment medications
Descripción

Relevant Concomitant/treatment medications

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2347852
UMLS CUI-3
C0304229
Drug Name
Descripción

(Trade Name preferred)

Tipo de datos

text

Alias
UMLS CUI [1]
C2360065
Dose of medication
Descripción

Dose of medication

Tipo de datos

float

Alias
UMLS CUI [1]
C3174092
Unit of dosage
Descripción

Unit of dosage

Tipo de datos

text

Alias
UMLS CUI [1]
C2348328
Frequency of medication
Descripción

Frequency of medication

Tipo de datos

text

Alias
UMLS CUI [1]
C3476109
Route of medication
Descripción

Route of medication

Tipo de datos

text

Alias
UMLS CUI [1]
C0013153
Start Date of medication
Descripción

day month year

Tipo de datos

date

Alias
UMLS CUI [1]
C2826734
Is the medication ongoing?
Descripción

If you tick No, please specify the End Date in the following item.

Tipo de datos

text

Alias
UMLS CUI [1]
C2826666
End Date of medication
Descripción

day month year

Tipo de datos

date

Alias
UMLS CUI [1]
C2826744
Primary Indication for medication
Descripción

Primary Indication

Tipo de datos

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C1519255
Drug Type
Descripción

Drug Type

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0332307
Relevant medical conditions/Risk factors
Descripción

Relevant medical conditions/Risk factors

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0035648
UMLS CUI-3
C1519255
Specific Condition Name
Descripción

Specify past or current medical disorders, allergies, surgeries, family or social history that may help explain the SAE.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348235
Date of onset
Descripción

day month year

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C0012634
Is the condition continuing?
Descripción

If you tick No, please specify the date of last occurrence in the following item.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0549178
Date of last occurrence
Descripción

day month year

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C2745955
UMLS CUI [1,4]
C0011008
Relevant diagnostic results
Descripción

Relevant diagnostic results

Alias
UMLS CUI-1
C0430022
UMLS CUI-2
C0456984
UMLS CUI-3
C1519255
Test Name
Descripción

Test Name

Tipo de datos

text

Alias
UMLS CUI [1]
C0022885
Test Date
Descripción

day month year

Tipo de datos

date

Alias
UMLS CUI [1]
C2826247
Test Result
Descripción

Test Result

Tipo de datos

text

Alias
UMLS CUI [1]
C0587081
Test Units
Descripción

Test Units

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0587081
Normal Low Range
Descripción

Normal Low Range

Tipo de datos

float

Alias
UMLS CUI [1,1]
C0086715
UMLS CUI [1,2]
C0205251
Normal High Range
Descripción

Normal High Range

Tipo de datos

float

Alias
UMLS CUI [1,1]
C0086715
UMLS CUI [1,2]
C0205250
Relevant diagnostic results not noted above
Descripción

Relevant diagnostic results not noted above

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0430022
UMLS CUI [1,2]
C0456984
UMLS CUI [1,3]
C0205394
Investigational Products
Descripción

Investigational Products

Alias
UMLS CUI-1
C0304229
If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
Descripción

Recurrence of event after investigational product administration

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0034897
UMLS CUI [1,3]
C0304229
UMLS CUI [1,4]
C1533734
General Narrative Comments
Descripción

General Narrative Comments

Alias
UMLS CUI-1
C0947611
UMLS CUI-2
C1519255
General narrative comments
Descripción

Provide a brief narrative description of SAE, possible other causes of the event (e.g. lack of efficacy, withdrawal of investigational product, the disease under study or other medical conditions) and details of the treatment.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1519255
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Similar models

Serious Adverse Event

1 formularios
  1. StudyEvent: ODM
    1. Serious Adverse Event
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Serious adverse events
C1519255 (UMLS CUI-1)
Item
Type of report
integer
C0585733 (UMLS CUI [1])
Type of report
Code List
Type of report
CL Item
Initial (1)
CL Item
Follow-up (2)
Item
Did SAE occur after initiation of study medication?
text
C2745955 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
SAE occurrence
Code List
Did SAE occur after initiation of study medication?
CL Item
Yes (Y)
CL Item
No (N)
Serious Adverse Event
Item
Serious Adverse Event
text
C1519255 (UMLS CUI [1])
Start Date of SAE
Item
Start Date of SAE
date
C0808070 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Outcome of SAE
integer
Outcome of SAE
Code List
Outcome of SAE
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae (4)
CL Item
Fatal (5)
End Date of SAE/Date of Death
Item
End Date of SAE/Date of Death
date
C0806020 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1148348 (UMLS CUI [2])
End Time of SAE
Item
End Time of SAE
time
C1522314 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Maximum Intensity
text
C0518690 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Maximum Intensity
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
Action Taken with Investigational Product(s) as a Result of the AE
text
C1704758 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Action Taken with Investigational Product(s) as a Result of the AE
Code List
Action Taken with Investigational Product(s) as a Result of the AE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (X)
Item
Did the subject withdraw from study as a result of this AE?
text
C2349954 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Withdrawal as result of SAE
Code List
Did the subject withdraw from study as a result of this AE?
CL Item
Yes (Y)
CL Item
No (N)
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
text
C0439849 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Relationship between SAE and investigational product
Code List
Is there a reasonable possibility that the AE may have been caused by the investigational product?
CL Item
Yes (Y)
CL Item
No (N)
Item
Was SAE caused by activities related to study participation (e.g. procedures)?
text
C0439849 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
Relation of SAE to study participation
Code List
Was SAE caused by activities related to study participation (e.g. procedures)?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Seriousness
C1710056 (UMLS CUI-1)
Results in death
Item
Specify the reason for considering this an SAE. Check all that apply. Results in death
boolean
C1519255 (UMLS CUI [1,1])
C0011065 (UMLS CUI [1,2])
Life-threatening
Item
Specify the reason for considering this an SAE. Check all that apply. Life-threatening
boolean
C1519255 (UMLS CUI [1,1])
C1517874 (UMLS CUI [1,2])
Requires hospitalisation or prolongation of existing hospitalisation
Item
Specify the reason for considering this an SAE. Check all that apply. Requires hospitalisation or prolongation of existing hospitalisation
boolean
C1519255 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
C0745041 (UMLS CUI [1,3])
Results in disability/incapacity
Item
Specify the reason for considering this an SAE. Check all that apply. Results in disability/incapacity
boolean
C1519255 (UMLS CUI [1,1])
C0231170 (UMLS CUI [1,2])
Congenital anomaly/birth defect
Item
Specify the reason for considering this an SAE. Check all that apply. Congenital anomaly/birth defect
boolean
C1519255 (UMLS CUI [1,1])
C0000768 (UMLS CUI [1,2])
Other reason
Item
Specify the reason for considering this an SAE. Check all that apply. Other
boolean
C1519255 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
Other reason, specification
Item
If other reason, please specify
text
C1519255 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Relevant Concomitant/treatment medications
C1519255 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1])
Dose of medication
Item
Dose of medication
float
C3174092 (UMLS CUI [1])
Item
Unit of dosage
text
C2348328 (UMLS CUI [1])
Unit of dosage
Code List
Unit of dosage
CL Item
ACTU (Actuation)
CL Item
AMP (Ampoule)
CL Item
AP (Application)
CL Item
BT (Bottle)
CL Item
CAP (Capsule)
CL Item
CC (Cubic centimeter)
CL Item
031 (Drops)
CL Item
002 (Gram)
CL Item
025 (International units)
CL Item
028 (International units per kilogram)
CL Item
IUML (International units per millilitre)
CL Item
011 (Litre)
CL Item
LM (Litre per minute)
CL Item
LOZ (Lozenge)
CL Item
MEGU (Megaunits (million units))
CL Item
004 (Microgram (MCG))
CL Item
004 (Microgram (UG))
CL Item
008 (Microgram/kilogram)
CL Item
MCG/KG/MIN (Microgram/kilogram per minute)
CL Item
MCG/MIN (Micrograms per minute)
CL Item
013 (Microlitre)
CL Item
029 (Milliequivalent)
CL Item
MEQ24 (Milliequivalent per 24 hours)
CL Item
003 (Milligram)
CL Item
MGPER (Milligrams percent)
CL Item
MGH (Milligram per hour)
CL Item
007 (Milligram/kilogram)
CL Item
MGKH (Milligram/kilogram per hour)
CL Item
MGKM (Milligram/kilogram per minute)
CL Item
009 (Milligram/metre squared)
CL Item
MGML (Milligram/millilitre)
CL Item
012 (Millilitre)
CL Item
MLH (Millilitre per hour)
CL Item
MLM (Millilitre per minute)
CL Item
023 (Millimole)
CL Item
027 (Million international units)
CL Item
MAC (Minimum alveolar concentration)
CL Item
NEB (Nebule)
CL Item
PAT (Patch)
CL Item
030 (Percent)
CL Item
PUFF (Puff)
CL Item
SAC (Sachet)
CL Item
SPR (Spray)
CL Item
SUP (Suppository)
CL Item
TBS (Tablespoon)
CL Item
TAB (Tablet)
CL Item
TSP (Teaspoon)
CL Item
UNT (Units)
CL Item
U (Unknown)
CL Item
VIA (Vial)
Item
Frequency of medication
text
C3476109 (UMLS CUI [1])
Frequency of medication
Code List
Frequency of medication
CL Item
2W (2 times per week)
CL Item
3W (3 times per week)
CL Item
4W (4 times per week)
CL Item
5D (5 times per day)
CL Item
5W (5 times per week)
CL Item
AC (AC)
CL Item
2D (BID)
CL Item
CO (Continuous infusion)
CL Item
FO (Every 2 weeks)
CL Item
Q3W (Every 3 weeks)
CL Item
Q3M (Every 3 months)
CL Item
AD (Every other day)
CL Item
1N (At Bedtime)
CL Item
MO (Once a month)
CL Item
WE (Once a week)
CL Item
1D (Once daily)
CL Item
1S (Once only)
CL Item
PC (PC)
CL Item
PRN (PRN)
CL Item
12D (Q2H)
CL Item
Q3D (Q3D)
CL Item
Q4D (Q4D)
CL Item
6D (Q4H)
CL Item
4D (Q6H)
CL Item
3D (Q8H)
CL Item
2D (Q12H)
CL Item
1M (QAM)
CL Item
24D (QH)
CL Item
4D (QID)
CL Item
1N (QPM)
CL Item
3D (TID)
CL Item
U (Unknown)
Item
Route of medication
text
C0013153 (UMLS CUI [1])
Route of medication
Code List
Route of medication
CL Item
047 (Both eyes)
CL Item
008 (Epidural)
CL Item
GT (Gastrostomy tube)
CL Item
055 (Inhalation)
CL Item
INJ (Injection)
CL Item
013 (Intra-arterial)
CL Item
IBU (Intra-bursa)
CL Item
026 (Intralesional)
CL Item
030 (Intramuscular)
CL Item
045 (Intranasal)
CL Item
031 (Intraocular)
CL Item
IOS (Intraosteal)
CL Item
033 (Intraperitoneal)
CL Item
037 (Intrathecal)
CL Item
015 (Intrauterine)
CL Item
042 (Intravenous)
CL Item
045 (Nasal)
CL Item
048 (Oral)
CL Item
054 (Rectal)
CL Item
058 (Subcutaneous)
CL Item
060 (Sublingual)
CL Item
061 (Topical)
CL Item
062 (Transdermal)
CL Item
065 (Unknown)
CL Item
067 (Vaginal)
Start Date of medication
Item
Start Date of medication
date
C2826734 (UMLS CUI [1])
Item
Is the medication ongoing?
text
C2826666 (UMLS CUI [1])
Medication ongoing
Code List
Is the medication ongoing?
CL Item
Yes (Y)
CL Item
No (N)
End Date of medication
Item
End Date of medication
date
C2826744 (UMLS CUI [1])
Primary Indication
Item
Primary Indication for medication
text
C3146298 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Item
Drug Type
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Drug Type
Code List
Drug Type
CL Item
2 (Concomitant)
CL Item
T (Treatment)
CL Item
1 (Cause of SAE)
Item Group
Relevant medical conditions/Risk factors
C0262926 (UMLS CUI-1)
C0035648 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
Specific Condition Name
Item
Specific Condition Name
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Date of onset
Item
Date of onset
date
C0574845 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Item
Is the condition continuing?
text
C0012634 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Condition continuing
Code List
Is the condition continuing?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
Date of last occurrence
Item
Date of last occurrence
date
C0012634 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Item Group
Relevant diagnostic results
C0430022 (UMLS CUI-1)
C0456984 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
Item
Test Name
text
C0022885 (UMLS CUI [1])
Test Name
Code List
Test Name
CL Item
Activated partial thromboplastin time (Activated partial thromboplastin time)
CL Item
Albumin (Albumin)
CL Item
Alkaline phosphatase (Alkaline phosphatase)
CL Item
Amylase (Amylase)
CL Item
Basophils (Basophils)
CL Item
Bicarbonate (Bicarbonate)
CL Item
Bilirubin (Bilirubin)
CL Item
Bilirubin direct (Bilirubin direct)
CL Item
Bilirubin total (Bilirubin total)
CL Item
Blood myoglobin (Blood myoglobin)
CL Item
Blood pH (Blood pH)
CL Item
Blood pressure (Blood pressure)
CL Item
Blood urea nitrogen (Blood urea nitrogen)
CL Item
Body temperature (Body temperature)
CL Item
Calcium (Calcium)
CL Item
CD4 lymphocytes (CD4 lymphocytes)
CL Item
CD8 lymphocytes (CD8 lymphocytes)
CL Item
Chloride (Chloride)
CL Item
Cholesterol total (Cholesterol total)
CL Item
C-reactive protein (C-reactive protein)
CL Item
Creatine (Creatine)
CL Item
Creatine phosphokinase (Creatine phosphokinase)
CL Item
Creatine phosphokinase MB (Creatine phosphokinase MB)
CL Item
Creatinine (Creatinine)
CL Item
Creatinine clearance (Creatinine clearance)
CL Item
Diastolic blood pressure (Diastolic blood pressure)
CL Item
Eosinophils (Eosinophils)
CL Item
Erythrocyte sedimentation rate (Erythrocyte sedimentation rate)
CL Item
Fasting blood glucose (Fasting blood glucose)
CL Item
FEV 1 (FEV 1)
CL Item
Gamma-glutamyltransferase (Gamma-glutamyltransferase)
CL Item
Glutamic-oxaloacetic transferase (Glutamic-oxaloacetic transferase)
CL Item
Glutamic-pyruvate transaminase (Glutamic-pyruvate transaminase)
CL Item
HbA1c (HbA1c)
CL Item
HBV-DNA decreased (HBV-DNA decreased)
CL Item
HBV-DNA increased (HBV-DNA increased)
CL Item
Heart rate (Heart rate)
CL Item
Hematocrit (Hematocrit)
CL Item
Hemoglobin (Hemoglobin)
CL Item
High density lipoprotein (High density lipoprotein)
CL Item
HIV viral load (HIV viral load)
CL Item
INR (INR)
CL Item
Lactic dehydrogenase (Lactic dehydrogenase)
CL Item
Lipase (Lipase)
CL Item
Low density lipoprotein (Low density lipoprotein)
CL Item
Lymphocytes (Lymphocytes)
CL Item
Magnesium (Magnesium)
CL Item
Mean cell hemoglobin concentration (Mean cell hemoglobin concentration)
CL Item
Mean corpuscular hemoglobin (Mean corpuscular hemoglobin)
CL Item
Mean corpuscular volume (Mean corpuscular volume)
CL Item
Monocytes (Monocytes)
CL Item
Neutrophils (Neutrophils)
CL Item
Oxygen saturation (Oxygen saturation)
CL Item
pCO2 (pCO2)
CL Item
pH (pH)
CL Item
Phosphate (Phosphate)
CL Item
Platelet count (Platelet count)
CL Item
pO2 (pO2)
CL Item
Potassium (Potassium)
CL Item
Protein total (Protein total)
CL Item
Prothrombin time (Prothrombin time)
CL Item
Red blood cell count (Red blood cell count)
CL Item
Respiratory rate (Respiratory rate)
CL Item
Reticulocyte count (Reticulocyte count)
CL Item
Serum glucose (Serum glucose)
CL Item
Serum uric acid (Serum uric acid)
CL Item
Sodium (Sodium)
CL Item
Systolic blood pressure (Systolic blood pressure)
CL Item
Thrombin time (Thrombin time)
CL Item
Total lung capacity (Total lung capacity)
CL Item
Triglycerides (Triglycerides)
CL Item
Troponin (Troponin)
CL Item
Troponin I (Troponin I)
CL Item
Troponin T (Troponin T)
CL Item
Urine myoglobin (Urine myoglobin)
CL Item
Urine pH (Urine pH)
CL Item
Vital capacity (Vital capacity)
CL Item
White blood cell count (White blood cell count)
Test Date
Item
Test Date
date
C2826247 (UMLS CUI [1])
Test Result
Item
Test Result
text
C0587081 (UMLS CUI [1])
Test Units
Item
Test Units
text
C1519795 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Normal Low Range
Item
Normal Low Range
float
C0086715 (UMLS CUI [1,1])
C0205251 (UMLS CUI [1,2])
Normal High Range
Item
Normal High Range
float
C0086715 (UMLS CUI [1,1])
C0205250 (UMLS CUI [1,2])
Relevant diagnostic results not noted above
Item
Relevant diagnostic results not noted above
text
C0430022 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item Group
Investigational Products
C0304229 (UMLS CUI-1)
Item
If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
text
C0877248 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C1533734 (UMLS CUI [1,4])
Recurrence of event after investigational product administration
Code List
If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
CL Item
No (N)
CL Item
Yes (Y)
CL Item
Unknown at this time (U)
CL Item
Not applicable (X)
Item Group
General Narrative Comments
C0947611 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
General narrative comments
Item
General narrative comments
text
C0947611 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
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