ID

34029

Description

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

Keywords

Versions (2)
  1. 11/9/18 11/9/18 -
  2. 1/11/19 1/11/19 -
Copyright Holder

GSK group of companies

Uploaded on

January 11, 2019

DOI

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License

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

English

Logs and Repeats: Adverse Event

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Site
Description

Site

Data type

text

Alias
UMLS CUI [1]
C2825164
Patient
Description

Patient

Data type

text

Alias
UMLS CUI [1]
C1299487
Patient Number
Description

Patient Number

Data type

integer

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1300638
Adverse Events
Description

Adverse Events

Alias
UMLS CUI-1
C0877248
Sequence Number
Description

Sequence Number

Data type

integer

Alias
UMLS CUI [1]
C2348184
Event Diagnosis Only (if known) Otherwise Sign/Symptom
Description

Event Diagnosis Only (if known) Otherwise Sign/Symptom

Data type

text

Alias
UMLS CUI [1]
C0011900
UMLS CUI [2]
C0037088
Modified Term
Description

Modified Term

Data type

text

Alias
UMLS CUI [1]
C2826302
Start Date
Description

Start Date

Data type

date

Alias
UMLS CUI [1]
C0808070
Start Time
Description

Start Time

Data type

time

Alias
UMLS CUI [1]
C1301880
Outcome
Description

Outcome

Data type

text

Alias
UMLS CUI [1]
C1705586
End Date
Description

if FATAL, Date of Death

Data type

date

Alias
UMLS CUI [1]
C0806020
End Time
Description

if FATAL, Time of Death

Data type

time

Alias
UMLS CUI [1]
C1522314
Frequency
Description

Frequency

Data type

text

Alias
UMLS CUI [1]
C0439603
Maximum Intensity
Description

Maximum Intensity

Data type

text

Alias
UMLS CUI [1]
C0518690
Action Taken with Investigational Product(s) as a Result of the AE
Description

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

Data type

text

Alias
UMLS CUI [1]
C1704758
UMLS CUI [2]
C0877248
Did the subject withdraw from study as a result of this AE?
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C1710677
UMLS CUI [2]
C0877248
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C0877248
Does the AE meet the definition of serious?
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C1519255
If YES, check all that apply
Description

If YES, check all that apply

Data type

text

Alias
UMLS CUI [1]
C1519255
If OTHER, specify
Description

If OTHER, specify

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C2348235
Was the SAE caused by an activity related to study participation (e.g., procedures)?
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0085978
UMLS CUI [2]
C1997894
Serious Flag
Description

Serious Flag

Data type

text

Alias
UMLS CUI [1]
C0205404
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Similar models

Logs and Repeats: Adverse Event

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Site
Item
Site
text
C2825164 (UMLS CUI [1])
Patient
Item
Patient
text
C1299487 (UMLS CUI [1])
Patient Number
Item
Patient Number
integer
C0030705 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Item Group
Adverse Events
C0877248 (UMLS CUI-1)
Sequence Number
Item
Sequence Number
integer
C2348184 (UMLS CUI [1])
Event Diagnosis Only (if known) Otherwise Sign/Symptom
Item
Event Diagnosis Only (if known) Otherwise Sign/Symptom
text
C0011900 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
Modified Term
Item
Modified Term
text
C2826302 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Start Time
Item
Start Time
time
C1301880 (UMLS CUI [1])
Item
Outcome
text
C1705586 (UMLS CUI [1])
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
C0806020 (UMLS CUI [1])
End Time
Item
End Time
time
C1522314 (UMLS CUI [1])
Item
Frequency
text
C0439603 (UMLS CUI [1])
Frequency
Code List
Frequency
CL Item
Single episode (1)
CL Item
Intermittent (2)
Item
Maximum Intensity
text
C0518690 (UMLS CUI [1])
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
C1704758 (UMLS CUI [1])
C0877248 (UMLS CUI [2])
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
C1710677 (UMLS CUI [1])
C0877248 (UMLS CUI [2])
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
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
Does the AE meet the definition of serious?
Item
Does the AE meet the definition of serious?
boolean
C1519255 (UMLS CUI [1])
Item
If YES, check all that apply
text
C1519255 (UMLS CUI [1])
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
C0205394 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
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
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1997894 (UMLS CUI [2])
Serious Flag
Item
Serious Flag
text
C0205404 (UMLS CUI [1])
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