ID

32636

Beschreibung

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

Stichworte

Versionen (2)
  1. 09.11.18 09.11.18 -
  2. 11.01.19 11.01.19 -
Rechteinhaber

GSK group of companies

Hochgeladen am

9. November 2018

DOI

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Lizenz

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

Englisch

Logs and Repeats: Adverse Event

1 Formulare  
Administrative data
Beschreibung

Administrative data

Site
Beschreibung

Site

Datentyp

text

Patient
Beschreibung

Patient

Datentyp

text

Patient Number
Beschreibung

Patient Number

Datentyp

integer

Adverse Events
Beschreibung

Adverse Events

Sequence Number
Beschreibung

Sequence Number

Datentyp

integer

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

Event Diagnosis Only (if known) Otherwise Sign/Symptom

Datentyp

text

Modified Term
Beschreibung

Modified Term

Datentyp

text

Start Date
Beschreibung

Start Date

Datentyp

date

Start Time
Beschreibung

Start Time

Datentyp

time

Outcome
Beschreibung

Outcome

Datentyp

text

End Date
Beschreibung

if FATAL, Date of Death

Datentyp

date

End Time
Beschreibung

if FATAL, Time of Death

Datentyp

time

Frequency
Beschreibung

Frequency

Datentyp

text

Maximum Intensity
Beschreibung

Maximum Intensity

Datentyp

text

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

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

Datentyp

text

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

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

Datentyp

boolean

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

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

Datentyp

boolean

Does the AE meet the definition of serious?
Beschreibung

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

Datentyp

boolean

If YES, check all that apply
Beschreibung

If YES, check all that apply

Datentyp

text

If OTHER, specify
Beschreibung

If OTHER, specify

Datentyp

text

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

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

Datentyp

boolean

Serious Flag
Beschreibung

Serious Flag

Datentyp

text

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Ähnliche Modelle

Logs and Repeats: Adverse Event

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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