ID

32636

Beschrijving

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

Trefwoorden

Versies (2)
  1. 09-11-18 09-11-18 -
  2. 11-01-19 11-01-19 -
Houder van rechten

GSK group of companies

Geüploaded op

9 november 2018

DOI

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Licentie

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

Engels

Logs and Repeats: Adverse Event

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Site
Beschrijving

Site

Datatype

text

Patient
Beschrijving

Patient

Datatype

text

Patient Number
Beschrijving

Patient Number

Datatype

integer

Adverse Events
Beschrijving

Adverse Events

Sequence Number
Beschrijving

Sequence Number

Datatype

integer

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

Event Diagnosis Only (if known) Otherwise Sign/Symptom

Datatype

text

Modified Term
Beschrijving

Modified Term

Datatype

text

Start Date
Beschrijving

Start Date

Datatype

date

Start Time
Beschrijving

Start Time

Datatype

time

Outcome
Beschrijving

Outcome

Datatype

text

End Date
Beschrijving

if FATAL, Date of Death

Datatype

date

End Time
Beschrijving

if FATAL, Time of Death

Datatype

time

Frequency
Beschrijving

Frequency

Datatype

text

Maximum Intensity
Beschrijving

Maximum Intensity

Datatype

text

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

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

Datatype

text

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

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

Datatype

boolean

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

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

Datatype

boolean

Does the AE meet the definition of serious?
Beschrijving

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

Datatype

boolean

If YES, check all that apply
Beschrijving

If YES, check all that apply

Datatype

text

If OTHER, specify
Beschrijving

If OTHER, specify

Datatype

text

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

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

Datatype

boolean

Serious Flag
Beschrijving

Serious Flag

Datatype

text

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Similar models

Logs and Repeats: Adverse Event

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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
Terug naar het begin van de pagina 

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