ID
35644
Beschreibung
Study ID: 103268 Clinical Study ID: 103268 Study Title: An Open Label, Randomised, Single Dose, Three-way Crossover Study to Investigate the Relative Bioavailability of Two Different Formulations of GSK163090 and the Effect of Food on the Pharmacokinetics of a Tablet Formulation in Healthy Male and Female Volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00536679 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK163090 capsule, fasted/fed Trade Name: N/A Study Indication: Depression; Depressive Disorder and Anxiety Disorders
Stichworte
Versionen (1)
- 13.03.19 13.03.19 -
Rechteinhaber
GSK group of companies
Hochgeladen am
13. März 2019
DOI
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Lizenz
Creative Commons BY-NC 3.0
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the Effect of Food on the Pharmacokinetics of a Tablet Formulation - 103268
Adverse Events
- StudyEvent: ODM
Beschreibung
Serious Adverse Event
Beschreibung
SECTION 1
Alias
- UMLS CUI-1
- C1828479
- UMLS CUI-2
- C1519255
Beschreibung
Record one SAE diagnosis per line, or a sign/symptom if the diagnosis is not available. If a diagnosis subsequently becomes available, this then should be entered and the sign/symptom crossed out, initialled and dated by the investigator. A separate form should be used for each SAE. However, if multiple SAEs which are temporally or clinically related are apparent at the time of initial reporting then these may be reported on the same page.
Datentyp
text
Alias
- UMLS CUI [1]
- C0011900
Beschreibung
Record the start date of the first occurrence of the SAE.
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C1519255
Beschreibung
Record the start date of the first occurrence of the SAE.
Datentyp
time
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C1519255
Beschreibung
All SAEs must be followed until the events are resolved, the condition stabilises, the events are otherwise explained, or the subject is lost to follow-up. Indicate if the event was ’Recovered/Resolved’ or ’Recovered/Resolved with sequelae’. If the SAE is ongoing at the time the subject completes the study or becomes lost to follow-up, the outcome must be recorded as ’Not recovered/Not resolved’ or ’Recovering/Resolving’. Also enter ’Not recovered/Not resolved’ if the SAE was ongoing at the time of death, but was not the cause of death, enter fatal for the SAE which was the direct cause of death.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C1519255
Beschreibung
Record the end date. This is the date the SAE Recovered/Resolved, or if the outcome was fatal, record the date the subject died. If the event Recovered/ Resolved with sequelae, enter the date the subject’s medical condition resolved or stabilised. Leave blank if the SAE is ’Not recovered/Not resolved’ or ’Recovering/Resolving’.
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C1519255
Beschreibung
Record the end time of the SAE.
Datentyp
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C1519255
Beschreibung
Record the maximum intensity that occurred over the duration of the event. Amend the intensity if it increases. Mild = An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate = An event that is sufficiently discomforting to interfere with everyday activities. Severe = An event that prevents normal everyday activities. Not applicable = Those event(s) where intensity is meaningless or impossible to determine (i.e., blindness and coma).
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C1519255
Beschreibung
Investigational product(s) withdrawn = Dose reduced = Dose increased = Dose not changed = Dose interrupted = Not applicable = Administration of investigational product(s) was permanently discontinued. Dose is reduced for one or more investigational product(s). Dose increased for one or more investigational product(s). Investigational product(s) continues even though an adverse event has occurred. Administration of one or more investigational product(s) was temporarily interrupted but then restarted. Subject was not receiving investigational product(s) when the event occurred (e.g., pre-or post-dosing) or the subject died and there was no prior decision to discontinue IP(s).
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1519255
Beschreibung
Indicate ’Yes’ if the event(s) were directly responsible for the subject’s withdrawal as indicated on the Study Conclusion page, otherwise indicate ’No’. If yes: Complete Study Conclusion page and check Adverse event as reason for withdrawal.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1519255
Beschreibung
It is a regulatory requirement for investigators to assess relationship to investigational product(s) based on information available. The assessment should be reviewed on receipt of any new information and amended if necessary. ’A reasonable possibility’ is meant to convey that there are facts/evidence or arguments to suggest a causal relationship. Facts/evidence or arguments that may support ’a reasonable possibility’ include, e.g., a temporal relationship, a pharmacologically-predicted event, or positive dechallenge or rechallenge. Confounding factors, such as concomitant medication, a concurrent illness, or relevant medical history, should also be considered.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0085978
- UMLS CUI [1,2]
- C1519255
Beschreibung
Section 2: Seriousness
Beschreibung
SAE results in death
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0011065
Beschreibung
SAE is life-threatening
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2826244
Beschreibung
SAE requires hospitalisation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0019993
Beschreibung
SAE results in disability/incapacity
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0231170
Beschreibung
Congenital anomaly/birth defect
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0000768
Beschreibung
Óther SAE
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1880177
Beschreibung
Other SAE specificationn
Datentyp
text
Alias
- UMLS CUI [1]
- C3845569
Beschreibung
SECTION 3: Demography Data
Alias
- UMLS CUI-1
- C0011298
- UMLS CUI-2
- C1828479
Beschreibung
SECTION 4
Alias
- UMLS CUI-1
- C1828479
Beschreibung
Section 5
Alias
- UMLS CUI-1
- C0015127
- UMLS CUI-2
- C1519255
Beschreibung
Possible Causes of SAE Other Than Investigational Product(s)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0015127
- UMLS CUI [1,2]
- C1519255
Beschreibung
If
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2348235
- UMLS CUI [1,2]
- C0012634
Beschreibung
If "Concomitant medication(s)", specify:
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2348235
- UMLS CUI [1,2]
- C2347852
Beschreibung
If "Other", specify:
Datentyp
text
Alias
- UMLS CUI [1]
- C2348235
Beschreibung
SECTION 6: RELEVANT Medical Conditions
Alias
- UMLS CUI-1
- C0262926
Beschreibung
Relevant Medical Conditions
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0262926
- UMLS CUI [1,3]
- C1519255
Beschreibung
Date of onset
Datentyp
date
Alias
- UMLS CUI [1]
- C0574845
Beschreibung
continuation SAE
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0805733
- UMLS CUI [1,2]
- C1519255
Beschreibung
Date of Last Occurrence
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C2745955
Beschreibung
Section 7
Beschreibung
SECTION 8 RELEVANT Concomitant Medications
Alias
- UMLS CUI-1
- C1828479
- UMLS CUI-2
- C2347852
Beschreibung
Drug Name
Datentyp
text
Alias
- UMLS CUI [1]
- C0013227
Beschreibung
Dose
Datentyp
integer
Alias
- UMLS CUI [1]
- C3174092
Beschreibung
Unit
Datentyp
text
Alias
- UMLS CUI [1]
- C1519795
Beschreibung
Frequency
Datentyp
text
Alias
- UMLS CUI [1]
- C3476109
Beschreibung
Route
Datentyp
text
Alias
- UMLS CUI [1]
- C0013153
Beschreibung
Taken Prior to Study?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2826667
Beschreibung
Start Date
Datentyp
date
Alias
- UMLS CUI [1]
- C0808070
Beschreibung
Stop Date
Datentyp
date
Alias
- UMLS CUI [1]
- C0806020
Beschreibung
Ongoing Medication?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2826666
Beschreibung
Reason for Medication
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Beschreibung
Section 9 - Investigational Product
Beschreibung
Section 10
Beschreibung
SECTION 11 Narrative Remarks
Alias
- UMLS CUI-1
- C1828479
- UMLS CUI-2
- C0947611
Beschreibung
Investigator's signature
Alias
- UMLS CUI-1
- C2346576
Beschreibung
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
Datentyp
text
Alias
- UMLS CUI [1]
- C2346576
Beschreibung
Investigator signature date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beschreibung
Investigator name
Datentyp
text
Alias
- UMLS CUI [1]
- C2826892
Ähnliche Modelle
Adverse Events
- StudyEvent: ODM
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1880177 (UMLS CUI [1,2])
C1828479 (UMLS CUI-2)
C0034897 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C2347852 (UMLS CUI-2)
C0013227 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0947611 (UMLS CUI-2)
C1519255 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])