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)
- 11/9/18 11/9/18 -
- 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
Logs and Repeats: Adverse Event
- StudyEvent: ODM
Description
Adverse Events
Alias
- UMLS CUI-1
- C0877248
Description
Sequence Number
Data type
integer
Alias
- UMLS CUI [1]
- C2348184
Description
Event Diagnosis Only (if known) Otherwise Sign/Symptom
Data type
text
Alias
- UMLS CUI [1]
- C0011900
- UMLS CUI [2]
- C0037088
Description
Modified Term
Data type
text
Alias
- UMLS CUI [1]
- C2826302
Description
Start Date
Data type
date
Alias
- UMLS CUI [1]
- C0808070
Description
Start Time
Data type
time
Alias
- UMLS CUI [1]
- C1301880
Description
Outcome
Data type
text
Alias
- UMLS CUI [1]
- C1705586
Description
if FATAL, Date of Death
Data type
date
Alias
- UMLS CUI [1]
- C0806020
Description
if FATAL, Time of Death
Data type
time
Alias
- UMLS CUI [1]
- C1522314
Description
Frequency
Data type
text
Alias
- UMLS CUI [1]
- C0439603
Description
Maximum Intensity
Data type
text
Alias
- UMLS CUI [1]
- C0518690
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
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
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
Description
If YES, complete paper SAE form and fax to GSK Safety within 24 hr
Data type
boolean
Alias
- UMLS CUI [1]
- C1519255
Description
If YES, check all that apply
Data type
text
Alias
- UMLS CUI [1]
- C1519255
Description
If OTHER, specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C2348235
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
Description
Serious Flag
Data type
text
Alias
- UMLS CUI [1]
- C0205404
Similar models
Logs and Repeats: Adverse Event
- StudyEvent: ODM
C1300638 (UMLS CUI [1,2])
C0037088 (UMLS CUI [2])
C0877248 (UMLS CUI [2])
C0877248 (UMLS CUI [2])
C0085978 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,2])
C1997894 (UMLS CUI [2])