ID
34029
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)
- 2018-11-09 2018-11-09 -
- 2019-01-11 2019-01-11 -
Rättsinnehavare
GSK group of companies
Uppladdad den
11 januari 2019
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
Logs and Repeats: Adverse Event
- StudyEvent: ODM
Beskrivning
Adverse Events
Alias
- UMLS CUI-1
- C0877248
Beskrivning
Sequence Number
Datatyp
integer
Alias
- UMLS CUI [1]
- C2348184
Beskrivning
Event Diagnosis Only (if known) Otherwise Sign/Symptom
Datatyp
text
Alias
- UMLS CUI [1]
- C0011900
- UMLS CUI [2]
- C0037088
Beskrivning
Modified Term
Datatyp
text
Alias
- UMLS CUI [1]
- C2826302
Beskrivning
Start Date
Datatyp
date
Alias
- UMLS CUI [1]
- C0808070
Beskrivning
Start Time
Datatyp
time
Alias
- UMLS CUI [1]
- C1301880
Beskrivning
Outcome
Datatyp
text
Alias
- UMLS CUI [1]
- C1705586
Beskrivning
if FATAL, Date of Death
Datatyp
date
Alias
- UMLS CUI [1]
- C0806020
Beskrivning
if FATAL, Time of Death
Datatyp
time
Alias
- UMLS CUI [1]
- C1522314
Beskrivning
Frequency
Datatyp
text
Alias
- UMLS CUI [1]
- C0439603
Beskrivning
Maximum Intensity
Datatyp
text
Alias
- UMLS CUI [1]
- C0518690
Beskrivning
Action Taken with Investigational Product(s) as a Result of the AE
Datatyp
text
Alias
- UMLS CUI [1]
- C1704758
- UMLS CUI [2]
- C0877248
Beskrivning
Did the subject withdraw from study as a result of this AE?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1710677
- UMLS CUI [2]
- C0877248
Beskrivning
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C0877248
Beskrivning
If YES, complete paper SAE form and fax to GSK Safety within 24 hr
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1519255
Beskrivning
If YES, check all that apply
Datatyp
text
Alias
- UMLS CUI [1]
- C1519255
Beskrivning
If OTHER, specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C2348235
Beskrivning
Was the SAE caused by an activity related to study participation (e.g., procedures)?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [2]
- C1997894
Beskrivning
Serious Flag
Datatyp
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])