ID

32636

Beskrivning

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

Nyckelord

Versioner (2)
  1. 2018-11-09 2018-11-09 -
  2. 2019-01-11 2019-01-11 -
Rättsinnehavare

GSK group of companies

Uppladdad den

9 november 2018

DOI

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Licens

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

Engelsk

Logs and Repeats: Adverse Event

1 Formulär  
Administrative data
Beskrivning

Administrative data

Site
Beskrivning

Site

Datatyp

text

Patient
Beskrivning

Patient

Datatyp

text

Patient Number
Beskrivning

Patient Number

Datatyp

integer

Adverse Events
Beskrivning

Adverse Events

Sequence Number
Beskrivning

Sequence Number

Datatyp

integer

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

Event Diagnosis Only (if known) Otherwise Sign/Symptom

Datatyp

text

Modified Term
Beskrivning

Modified Term

Datatyp

text

Start Date
Beskrivning

Start Date

Datatyp

date

Start Time
Beskrivning

Start Time

Datatyp

time

Outcome
Beskrivning

Outcome

Datatyp

text

End Date
Beskrivning

if FATAL, Date of Death

Datatyp

date

End Time
Beskrivning

if FATAL, Time of Death

Datatyp

time

Frequency
Beskrivning

Frequency

Datatyp

text

Maximum Intensity
Beskrivning

Maximum Intensity

Datatyp

text

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

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

Datatyp

text

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

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

Datatyp

boolean

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

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

Datatyp

boolean

Does the AE meet the definition of serious?
Beskrivning

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

Datatyp

boolean

If YES, check all that apply
Beskrivning

If YES, check all that apply

Datatyp

text

If OTHER, specify
Beskrivning

If OTHER, specify

Datatyp

text

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

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

Datatyp

boolean

Serious Flag
Beskrivning

Serious Flag

Datatyp

text

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Similar models

Logs and Repeats: Adverse Event

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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