ID

29503

Descripción

Study ID: 104257 Clinical Study ID: CRV104257 Study Title: A randomized, open-label, two period, period balanced, crossover study to estimate the relative bioavailability of an investigational drug compared to Coreg IR in healthy adult volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension Documentation part: Serious Adverse Event

Palabras clave

Versiones (1)
  1. 4/4/18 4/4/18 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

4 de abril de 2018

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
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Bioavailability of an investigational drug compared to Coreg IR in healthy adults GSK104257

Inglés

Serious Adverse Event

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

Serious Adverse Event

Alias
UMLS CUI-1
C1519255
Subject Identifier
Descripción

Subject Identifier

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Centre Number
Descripción

Centre Number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0019994
UMLS CUI [1,2]
C0600091
Randomisation Number
Descripción

Randomisation Number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Did the subject experience a serious adverse event during the study?
Descripción

serious adverse event

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1519255
Serious Adverse Event Diagnosis Only (if known) Otherwise Sign/Symptom
Descripción

Serious Adverse Event

Tipo de datos

text

Alias
UMLS CUI [1]
C1519255
Serious Adverse Event Start Date
Descripción

Serious Adverse Event Start Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2697888
Start Time Serious Adverse Event
Descripción

Start Time Serious Adverse Event

Tipo de datos

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2697889
Serious Adverse Event End Date
Descripción

Serious Adverse Event End Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2697886
Serious Adverse Event End Time
Descripción

Serious Adverse Event End Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826658
Outcome
Descripción

Outcome

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1624730
UMLS CUI [1,2]
C1519255
Date of Death
Descripción

Date of Death

Tipo de datos

date

Alias
UMLS CUI [1]
C1148348
If fatal, was a post-mortem/autopsy performed
Descripción

autopsy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0004398
UMLS CUI [1,2]
C1519255
Maximum Intensity
Descripción

Maximum Intensity

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C1519255
Action Taken with Respect to Investigational Drug
Descripción

Action Taken

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1547656
UMLS CUI [1,2]
C1519255
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Descripción

Relationship investigational product

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1519255
Did the subject withdraw from study as a result of this AE?
Descripción

Did the subject withdraw from study as a result of this AE?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C1519255
Seriousness, Specify the reason for considering this an SAE
Descripción

Seriousness

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C0392360
Possible Cause of SAE Other Than Investigational Product(s):
Descripción

SAE Causation

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C3641099
UMLS CUI [1,2]
C1519255
If other ossible Cause of SAE, specify
Descripción

SAE Causation

Tipo de datos

text

Alias
UMLS CUI [1,1]
C3641099
UMLS CUI [1,2]
C1519255
If deliberate or inadvertent administration of further dose(s) of investigational product(s) to the subject occurred, did the reported adverse event recur?
Descripción

adverse event recur

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C0034897
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
Descripción

Serious Adverse Event Recurrence

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0034897
UMLS CUI [1,3]
C0304229
Details of RELEVANT Assessments (provide details of any other tests/procedures which were carried out to diagnose or confirm the SAE e.g., laboratory data with units and normal range)
Descripción

Details of relevant Assessments

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0430022
UMLS CUI [1,2]
C1519255
General narrative comments
Descripción

General narrative comments

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0678257
Investigator’s signature
Descripción

Investigator’s signature

Tipo de datos

text

Alias
UMLS CUI [1]
C2346576
Demography Data
Descripción

Demography Data

Alias
UMLS CUI-1
C0011298
UMLS CUI-2
C1519255
Date of birth
Descripción

Date of birth

Tipo de datos

date

Alias
UMLS CUI [1]
C0421451
Sex
Descripción

Sex

Tipo de datos

integer

Alias
UMLS CUI [1]
C0079399
Weight
Descripción

Weight

Tipo de datos

float

Unidades de medida
  • kG
Alias
UMLS CUI [1]
C0005910
kG
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

Specific Condition name

Tipo de datos

text

Alias
UMLS CUI [1]
C0012634
Date of onset
Descripción

Date of onset

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0574845
Condition Present at Time of the SAE?
Descripción

Condition Present at Time of the SAE

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1519255
No, specify date of last occurrence
Descripción

date of last occurrence

Tipo de datos

date

Alias
UMLS CUI [1,1]
C2745955
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0011008
Relevant concomitant medications
Descripción

Relevant concomitant medications

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C1519255
Drug name
Descripción

Drug name

Tipo de datos

text

Alias
UMLS CUI [1]
C2360065
Total Daily Dose
Descripción

Total Daily Dose

Tipo de datos

float

Alias
UMLS CUI [1]
C2348070
Unit
Descripción

Unit

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1519795
Frequency
Descripción

Frequency

Tipo de datos

integer

Alias
UMLS CUI [1]
C3476109
Route
Descripción

Route

Tipo de datos

integer

Alias
UMLS CUI [1]
C0013153
Taken Prior to Study?
Descripción

Taken Prior to Study?

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2826667
Start Date
Descripción

start date of medication

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
End Date
Descripción

End Date of medication

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Medication Ongoing?
Descripción

Medication Ongoing

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2826666
Reason for Medication
Descripción

Reason for Medication

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C3146298
Details of Investigational Product(s)
Descripción

Details of Investigational Product(s)

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C1519255
Investigational Product Period and Formulation
Descripción

Investigational Product Period and Formulation

Tipo de datos

text

Alias
UMLS CUI [1]
C0304229
Date of Dose
Descripción

Date of Dose

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0011008
Time of Dose
Descripción

Time of Dose

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0040223
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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
Serious Adverse Event
C1519255 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Centre Number
Item
Centre Number
integer
C0019994 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Randomisation Number
Item
Randomisation Number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
serious adverse event
Item
Did the subject experience a serious adverse event during the study?
boolean
C1519255 (UMLS CUI [1])
Serious Adverse Event
Item
Serious Adverse Event Diagnosis Only (if known) Otherwise Sign/Symptom
text
C1519255 (UMLS CUI [1])
Serious Adverse Event Start Date
Item
Serious Adverse Event Start Date
date
C1519255 (UMLS CUI [1,1])
C2697888 (UMLS CUI [1,2])
Start Time Serious Adverse Event
Item
Start Time Serious Adverse Event
time
C1519255 (UMLS CUI [1,1])
C2697889 (UMLS CUI [1,2])
Serious Adverse Event End Date
Item
Serious Adverse Event End Date
date
C1519255 (UMLS CUI [1,1])
C2697886 (UMLS CUI [1,2])
Serious Adverse Event End Time
Item
Serious Adverse Event End Time
time
C1519255 (UMLS CUI [1,1])
C2826658 (UMLS CUI [1,2])
Item
Outcome
integer
C1624730 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Outcome
Code List
Outcome
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, record Date of Death  (5)
Date of Death
Item
Date of Death
date
C1148348 (UMLS CUI [1])
autopsy
Item
If fatal, was a post-mortem/autopsy performed
boolean
C0004398 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Maximum Intensity
integer
C0518690 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Intensity (maximum)
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Item
Action Taken with Respect to Investigational Drug
integer
C1547656 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Action Taken
Code List
Action Taken with Respect to Investigational Drug
CL Item
lnvestigational 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 (6)
Relationship investigational product
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Did the subject withdraw from study as a result of this AE?
Item
Did the subject withdraw from study as a result of this AE?
boolean
C1710677 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Seriousness, Specify the reason for considering this an SAE
integer
C1710056 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Seriousness
Code List
Seriousness, Specify the reason for considering this an SAE
CL Item
Results in death (1)
CL Item
Is life-threatening (2)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (3)
CL Item
Results in disability/incapacity (4)
CL Item
Congenital anomaly/birth defect (5)
CL Item
Other, specify within general narrative comment (6)
Item
Possible Cause of SAE Other Than Investigational Product(s):
integer
C3641099 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
SAE Causation
Code List
Possible Cause of SAE Other Than Investigational Product(s):
CL Item
Disease under study  (1)
CL Item
Medical condition(s)  (2)
CL Item
Lack of efficacy (3)
CL Item
Withdrawal of investigational product(s) (4)
CL Item
Concomitant medication  (5)
CL Item
Activity related to study participation  (6)
CL Item
Other, specify (7)
SAE Causation
Item
If other ossible Cause of SAE, specify
text
C3641099 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
adverse event recur
Item
If deliberate or inadvertent administration of further dose(s) of investigational product(s) to the subject occurred, did the reported adverse event recur?
boolean
C0304229 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0034897 (UMLS CUI [1,3])
Serious Adverse Event Recurrence
Item
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
boolean
C1519255 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Details of relevant Assessments
Item
Details of RELEVANT Assessments (provide details of any other tests/procedures which were carried out to diagnose or confirm the SAE e.g., laboratory data with units and normal range)
text
C0430022 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
General narrative comments
Item
General narrative comments
text
C1519255 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Investigator’s signature
Item
Investigator’s signature
text
C2346576 (UMLS CUI [1])
Item Group
Demography Data
C0011298 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
integer
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (1)
CL Item
Female (2)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
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])
Date of onset
Item
Date of onset
date
C0012634 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Condition Present at Time of the SAE
Item
Condition Present at Time of the SAE?
boolean
C0012634 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
date of last occurrence
Item
No, specify date of last occurrence
date
C2745955 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
Relevant concomitant medications
C2347852 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Drug name
Item
Drug name
text
C2360065 (UMLS CUI [1])
Total Daily Dose
Item
Total Daily Dose
float
C2348070 (UMLS CUI [1])
Item
Unit
integer
C0013227 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Unit
Code List
Unit
CL Item
Actuation ACTU (1)
CL Item
Ampoule AMP (2)
CL Item
Application AP (3)
CL Item
Bottle BT (4)
CL Item
Capsule CAP (5)
CL Item
Cubic centimeter cc (6)
CL Item
Drops 031 (7)
CL Item
Gram 002 (8)
CL Item
International units  (9)
CL Item
International units per kilogram  (10)
CL Item
Internatcional units per millilitre IUML (11)
CL Item
Litre  (12)
CL Item
Litre per minute LM (13)
CL Item
Lozenge LOZ (14)
CL Item
Megaunits (million units) MEGU (15)
CL Item
Microgram (MCG) (16)
CL Item
Microgram (UG)  (17)
CL Item
Microgram /kilogram (18)
CL Item
Microgram/kilogram per minute MCG/KG/MIN (19)
CL Item
Micrograms per minute MCG/MIN (20)
CL Item
Micro litre  (21)
CL Item
Milliequivalent (22)
CL Item
Milliequivalent per 24 hours MEQ24 (23)
CL Item
Milligram  (24)
CL Item
Milligrams percent MGPER (25)
CL Item
Milligram per hour MGH (26)
CL Item
Milligram/kilogram (27)
CL Item
Milligram/kilogram per hour MGKH (28)
CL Item
Milligram/kilogram per minute MGKM (29)
CL Item
Milligram/metre squared (30)
CL Item
Milligram/millilitre MGML (31)
CL Item
Millilitre (32)
CL Item
Millilitre per hour MLH (33)
CL Item
Millilitre per minute MLM (34)
CL Item
Millimole (35)
CL Item
Million international units (36)
CL Item
Minimum alveolar concentration MAC (37)
CL Item
Nebule NEB (38)
CL Item
Patch PAT (39)
CL Item
Percent (40)
CL Item
Puff PUFF (41)
CL Item
Sachet SAC (42)
CL Item
Spray SPR (43)
CL Item
Suppository SUP (44)
CL Item
Tablespoon TBS (45)
CL Item
Tablet TAB (46)
CL Item
Teaspoon TSP (47)
CL Item
Units UNT (48)
CL Item
Unknown u (49)
CL Item
Vial VIA (50)
Item
Frequency
integer
C3476109 (UMLS CUI [1])
Frequency
Code List
Frequency
CL Item
2 times per week 2W (1)
CL Item
3 times per week 3W (2)
CL Item
4times per week 4W (3)
CL Item
5 times per day 50 (4)
CL Item
5 times per week SW (5)
CL Item
AC AC (6)
CL Item
BID 2D (7)
CL Item
Continuous Infusion co (8)
CL Item
Every 2 weeks FO (9)
CL Item
Every 3 weeks Q3WK (10)
CL Item
Every 3 months Q3M (11)
CL Item
Every other day AD (12)
CL Item
At Bedtime IN (13)
CL Item
Once a month MO (14)
CL Item
Once a week WE (15)
CL Item
Once daily 1D (16)
CL Item
Once only 15 (17)
CL Item
PC PC  (18)
CL Item
PRN PRN (19)
CL Item
Q2H 12D (20)
CL Item
Q3D Q3D (21)
CL Item
Q4D Q4D (22)
CL Item
Q4H 6D (23)
CL Item
Q6H 4D (24)
CL Item
Q8H 3D (25)
CL Item
Q12H 2D (26)
CL Item
QAM lM (27)
CL Item
QH 24D (28)
CL Item
QID 4D (29)
CL Item
QPM lN (30)
CL Item
TIO 3D (31)
CL Item
Unknown u (32)
Item
Route
integer
C0013153 (UMLS CUI [1])
Route
Code List
Route
CL Item
Both eyes 047 (1)
CL Item
Epidural 008 (2)
CL Item
Gastrostomy tube GT (3)
CL Item
Inhalation 055 (4)
CL Item
Injection INJ (5)
CL Item
Intra-arterial 013 (6)
CL Item
Intra-buru IBU (7)
CL Item
Intralesional 026 (8)
CL Item
IM Intramuscular 030 (9)
CL Item
Intranasal 045 (10)
CL Item
Intraocular 031 (11)
CL Item
Intraosteal 10S (12)
CL Item
Intraperitoneal 033 (13)
CL Item
lntrathecal 037 (14)
CL Item
Intrauterine 015 (15)
CL Item
IV Intravenous 042 (16)
CL Item
Nasal 045 (17)
CL Item
Oral 048 (18)
CL Item
Rectal 054 (19)
CL Item
Subcutaneous 058 (20)
CL Item
Sublingua1 060 (21)
CL Item
Topical 061 (22)
CL Item
Transdermal 062 (23)
CL Item
Unknown 065 (24)
CL Item
Vaginal 067 (25)
Taken Prior to Study?
Item
Taken Prior to Study?
boolean
C2826667 (UMLS CUI [1])
start date of medication
Item
Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
End Date of medication
Item
End Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Medication Ongoing
Item
Medication Ongoing?
boolean
C2826666 (UMLS CUI [1])
Reason for Medication
Item
Reason for Medication
text
C2347852 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Item Group
Details of Investigational Product(s)
C0304229 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Investigational Product Period and Formulation
Item
Investigational Product Period and Formulation
text
C0304229 (UMLS CUI [1])
Date of Dose
Item
Date of Dose
date
C0304229 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of Dose
Item
Time of Dose
time
C0304229 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
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