ID

32636

Descripción

Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR 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

Palabras clave

Versiones (2)
  1. 9/11/18 9/11/18 -
  2. 11/1/19 11/1/19 -
Titular de derechos de autor

GSK group of companies

Subido en

9 de noviembre de 2018

DOI

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Licencia

Creative Commons BY-NC 3.0
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A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904

Inglés

Logs and Repeats: Adverse Event

1 formularios  
Administrative data
Descripción

Administrative data

Site
Descripción

Site

Tipo de datos

text

Patient
Descripción

Patient

Tipo de datos

text

Patient Number
Descripción

Patient Number

Tipo de datos

integer

Adverse Events
Descripción

Adverse Events

Sequence Number
Descripción

Sequence Number

Tipo de datos

integer

Event Diagnosis Only (if known) Otherwise Sign/Symptom
Descripción

Event Diagnosis Only (if known) Otherwise Sign/Symptom

Tipo de datos

text

Modified Term
Descripción

Modified Term

Tipo de datos

text

Start Date
Descripción

Start Date

Tipo de datos

date

Start Time
Descripción

Start Time

Tipo de datos

time

Outcome
Descripción

Outcome

Tipo de datos

text

End Date
Descripción

if FATAL, Date of Death

Tipo de datos

date

End Time
Descripción

if FATAL, Time of Death

Tipo de datos

time

Frequency
Descripción

Frequency

Tipo de datos

text

Maximum Intensity
Descripción

Maximum Intensity

Tipo de datos

text

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

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

Is there a reasonable possibility that the AE may have been caused by the investigational product?
Descripción

Is there a reasonable possibility that the AE may have been caused by the investigational product?

Tipo de datos

boolean

Does the AE meet the definition of serious?
Descripción

If YES, complete paper SAE form and fax to GSK Safety within 24 hr

Tipo de datos

boolean

If YES, check all that apply
Descripción

If YES, check all that apply

Tipo de datos

text

If OTHER, specify
Descripción

If OTHER, specify

Tipo de datos

text

Was the SAE caused by an activity related to study participation (e.g., procedures)?
Descripción

Was the SAE caused by an activity related to study participation (e.g., procedures)?

Tipo de datos

boolean

Serious Flag
Descripción

Serious Flag

Tipo de datos

text

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Similar models

Logs and Repeats: Adverse Event

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative data
Site
Item
Site
text
Patient
Item
Patient
text
Patient Number
Item
Patient Number
integer
Item Group
Adverse Events
Sequence Number
Item
Sequence Number
integer
Event Diagnosis Only (if known) Otherwise Sign/Symptom
Item
Event Diagnosis Only (if known) Otherwise Sign/Symptom
text
Modified Term
Item
Modified Term
text
Start Date
Item
Start Date
date
Start Time
Item
Start Time
time
Item
Outcome
text
Outcome
Code List
Outcome
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not reslved (3)
CL Item
Recovered/Resolved with sequelae (4)
CL Item
Fatal (5)
End Date
Item
End Date
date
End Time
Item
End Time
time
Item
Frequency
text
Frequency
Code List
Frequency
CL Item
Single episode (1)
CL Item
Intermittent (2)
Item
Maximum Intensity
text
Maximum Intensity
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 Investigational Product(s) as a Result of the AE
text
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 (6)
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
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
Does the AE meet the definition of serious?
Item
Does the AE meet the definition of serious?
boolean
Item
If YES, check all that apply
text
If YES, check all that apply
Code List
If YES, check all that apply
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 (6)
If OTHER, specify
Item
If OTHER, specify
text
Was the SAE caused by an activity related to study participation (e.g., procedures)?
Item
Was the SAE caused by an activity related to study participation (e.g., procedures)?
boolean
Serious Flag
Item
Serious Flag
text
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