ID

35644

Beskrivning

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

Nyckelord

Versioner (1)
  1. 2019-03-13 2019-03-13 -
Rättsinnehavare

GSK group of companies

Uppladdad den

13 mars 2019

DOI

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Licens

Creative Commons BY-NC 3.0
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the Effect of Food on the Pharmacokinetics of a Tablet Formulation - 103268

Engelsk

Adverse Events

1 Formulär  
  1. StudyEvent: ODM
    1. Adverse Events
Administrative data
Beskrivning

Administrative data

Date of Visit
Beskrivning

Visit Date

Datatyp

date

Subject Identifier
Beskrivning

Subject Identifier

Datatyp

integer

Centre Number
Beskrivning

Centre Number

Datatyp

integer

Randomisation Number
Beskrivning

Randomisation Number

Datatyp

integer

Serious Adverse Event
Beskrivning

Serious Adverse Event

Did the subject experience a serious adverse event during the study?
Beskrivning

serious adverse event

Datatyp

boolean

SECTION 1
Beskrivning

SECTION 1

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C1519255
Diagnosis Only (if known) Otherwise Sign/Symptom
Beskrivning

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.

Datatyp

text

Alias
UMLS CUI [1]
C0011900
Start Date
Beskrivning

Record the start date of the first occurrence of the SAE.

Datatyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1519255
Start Time
Beskrivning

Record the start date of the first occurrence of the SAE.

Datatyp

time

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C1519255
Outcome
Beskrivning

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.

Datatyp

integer

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1519255
End Date
Beskrivning

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’.

Datatyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1519255
End Time
Beskrivning

Record the end time of the SAE.

Datatyp

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C1519255
Maximum Intensity
Beskrivning

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).

Datatyp

text

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C1519255
Actions taken with Investigational Product(s) as a Result of the SAE
Beskrivning

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).

Datatyp

text

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1519255
Did the subject withdraw from study as a result of this SAE? If yes: Complete Study Conclusion page and tick Adverse event as reason for withdrawal.
Beskrivning

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.

Datatyp

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1519255
Is there a reasonable possibility the SAE may have been caused by the investigational product?
Beskrivning

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.

Datatyp

text

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C1519255
Section 2: Seriousness
Beskrivning

Section 2: Seriousness

[A] Results in death
Beskrivning

SAE results in death

Datatyp

boolean

Alias
UMLS CUI [1]
C0011065
[B] Is life-threatening
Beskrivning

SAE is life-threatening

Datatyp

boolean

Alias
UMLS CUI [1]
C2826244
[C] Requires hospitalisation or prolongation of existing hospitalisation
Beskrivning

SAE requires hospitalisation

Datatyp

boolean

Alias
UMLS CUI [1]
C0019993
[D] Results in disability/incapacity
Beskrivning

SAE results in disability/incapacity

Datatyp

boolean

Alias
UMLS CUI [1]
C0231170
[E] Congenital anomaly/birth defect
Beskrivning

Congenital anomaly/birth defect

Datatyp

boolean

Alias
UMLS CUI [1]
C0000768
[F] Other
Beskrivning

Óther SAE

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1880177
Other, specify
Beskrivning

Other SAE specificationn

Datatyp

text

Alias
UMLS CUI [1]
C3845569
SECTION 3: Demography Data
Beskrivning

SECTION 3: Demography Data

Alias
UMLS CUI-1
C0011298
UMLS CUI-2
C1828479
Date of birth
Beskrivning

Date of birth

Datatyp

date

Alias
UMLS CUI [1]
C0421451
Sex
Beskrivning

Sex

Datatyp

text

Alias
UMLS CUI [1]
C0079399
Weight
Beskrivning

Weight

Datatyp

float

Måttenheter
  • kg
Alias
UMLS CUI [1]
C0005910
kg
SECTION 4
Beskrivning

SECTION 4

Alias
UMLS CUI-1
C1828479
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
Beskrivning

Adverse event Recurrence

Datatyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0034897
Section 5
Beskrivning

Section 5

Alias
UMLS CUI-1
C0015127
UMLS CUI-2
C1519255
Possible Causes of SAE Other Than Investigational Product(s)
Beskrivning

Possible Causes of SAE Other Than Investigational Product(s)

Datatyp

text

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C1519255
If "Medical condition(s)", specify:
Beskrivning

If

Datatyp

text

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C0012634
If "Concomitant medication(s)", specify:
Beskrivning

If "Concomitant medication(s)", specify:

Datatyp

text

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C2347852
If "Other", specify:
Beskrivning

If "Other", specify:

Datatyp

text

Alias
UMLS CUI [1]
C2348235
SECTION 6: RELEVANT Medical Conditions
Beskrivning

SECTION 6: RELEVANT Medical Conditions

Alias
UMLS CUI-1
C0262926
Specify any relevant past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE.
Beskrivning

Relevant Medical Conditions

Datatyp

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0262926
UMLS CUI [1,3]
C1519255
Date of onset
Beskrivning

Date of onset

Datatyp

date

Alias
UMLS CUI [1]
C0574845
Condition Present at Time of the SAE?
Beskrivning

continuation SAE

Datatyp

text

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C1519255
If No, Date of Last Occurrence
Beskrivning

Date of Last Occurrence

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2745955
Section 7
Beskrivning

Section 7

Other RELEVANT Risk Factors (provide any family or social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE)
Beskrivning

Other risk factors relevant to SAE

Datatyp

integer

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C1519255
SECTION 8 RELEVANT Concomitant Medications
Beskrivning

SECTION 8 RELEVANT Concomitant Medications

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C2347852
Drug Name
Beskrivning

Drug Name

Datatyp

text

Alias
UMLS CUI [1]
C0013227
Dose
Beskrivning

Dose

Datatyp

integer

Alias
UMLS CUI [1]
C3174092
Unit
Beskrivning

Unit

Datatyp

text

Alias
UMLS CUI [1]
C1519795
Frequency
Beskrivning

Frequency

Datatyp

text

Alias
UMLS CUI [1]
C3476109
Route
Beskrivning

Route

Datatyp

text

Alias
UMLS CUI [1]
C0013153
Taken Prior to Study?
Beskrivning

Taken Prior to Study?

Datatyp

boolean

Alias
UMLS CUI [1]
C2826667
Start Date
Beskrivning

Start Date

Datatyp

date

Alias
UMLS CUI [1]
C0808070
Stop Date
Beskrivning

Stop Date

Datatyp

date

Alias
UMLS CUI [1]
C0806020
Ongoing Medication?
Beskrivning

Ongoing Medication?

Datatyp

boolean

Alias
UMLS CUI [1]
C2826666
Reason for Medication
Beskrivning

Reason for Medication

Datatyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
Section 9 - Investigational Product
Beskrivning

Section 9 - Investigational Product

Record details of investigational product
Beskrivning

Record details of investigational product

Datatyp

text

Section 10
Beskrivning

Section 10

Details of RELEVANT Assessments (provide details of any other tests/procedures which were carried out to diagnose or confirm the SAE e.g., laboratory data with units and normal range)
Beskrivning

Details of relevant assessments

Datatyp

text

Alias
UMLS CUI [1,1]
C1261322
UMLS CUI [1,2]
C1519255
SECTION 11 Narrative Remarks
Beskrivning

SECTION 11 Narrative Remarks

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C0947611
Narrative Remarks (provide a brief narrative description of the SAE and details of treatment given)
Beskrivning

Narrative Remarks

Datatyp

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1519255
Investigator's signature
Beskrivning

Investigator's signature

Alias
UMLS CUI-1
C2346576
Investigator's signature
Beskrivning

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.

Datatyp

text

Alias
UMLS CUI [1]
C2346576
Investigator signature date
Beskrivning

Investigator signature date

Datatyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Printed Investigator's name
Beskrivning

Investigator name

Datatyp

text

Alias
UMLS CUI [1]
C2826892
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Similar models

Adverse Events

1 Formulär
  1. StudyEvent: ODM
    1. Adverse Events
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
Visit Date
Item
Date of Visit
date
Subject Identifier
Item
Subject Identifier
integer
Centre Number
Item
Centre Number
integer
Randomisation Number
Item
Randomisation Number
integer
Item Group
Serious Adverse Event
serious adverse event
Item
Did the subject experience a serious adverse event during the study?
boolean
Item Group
SECTION 1
C1828479 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Event
Item
Diagnosis Only (if known) Otherwise Sign/Symptom
text
C0011900 (UMLS CUI [1])
Start Date of the Serious Adverse Event
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Start Time of Serious Adverse Event
Item
Start Time
time
C1301880 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Outcome
integer
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Outcome
Code List
Outcome
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae (4)
CL Item
Fatal (5)
End Date of Serious Adverse Event
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
End Time of Serious Adverse Event
Item
End Time
time
C1522314 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Maximum Intensity
text
C1710056 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Maximum Intensity
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
Actions taken with Investigational Product(s) as a Result of the SAE
text
C1704758 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Actions taken with Investigational Product(s) as a Result of the SAE
Code List
Actions taken with Investigational Product(s) as a Result of the SAE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Doce increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (X)
Item
Did the subject withdraw from study as a result of this SAE? If yes: Complete Study Conclusion page and tick Adverse event as reason for withdrawal.
text
C0422727 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Did the subject withdraw from study as a result of this SAE?
Code List
Did the subject withdraw from study as a result of this SAE? If yes: Complete Study Conclusion page and tick Adverse event as reason for withdrawal.
CL Item
No (N)
CL Item
Yes (Y)
Item
Is there a reasonable possibility the SAE may have been caused by the investigational product?
text
C0085978 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Is there a reasonable possibility the SAE may have been caused by the investigational product?
Code List
Is there a reasonable possibility the SAE may have been caused by the investigational product?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Section 2: Seriousness
SAE results in death
Item
[A] Results in death
boolean
C0011065 (UMLS CUI [1])
SAE is life-threatening
Item
[B] Is life-threatening
boolean
C2826244 (UMLS CUI [1])
SAE requires hospitalisation
Item
[C] Requires hospitalisation or prolongation of existing hospitalisation
boolean
C0019993 (UMLS CUI [1])
SAE results in disability/incapacity
Item
[D] Results in disability/incapacity
boolean
C0231170 (UMLS CUI [1])
Congenital anomaly/birth defect
Item
[E] Congenital anomaly/birth defect
boolean
C0000768 (UMLS CUI [1])
Óther SAE
Item
[F] Other
boolean
C1519255 (UMLS CUI [1,1])
C1880177 (UMLS CUI [1,2])
Other SAE specificationn
Item
Other, specify
text
C3845569 (UMLS CUI [1])
Item Group
SECTION 3: Demography Data
C0011298 (UMLS CUI-1)
C1828479 (UMLS CUI-2)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Seriousness
Code List
Sex
CL Item
Male (Male)
CL Item
Female (Female)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
SECTION 4
C1828479 (UMLS CUI-1)
Item
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
text
C0877248 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
Adverse event Recurrence
Code List
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Unknown at this time (Unknown at this time)
CL Item
Not applicable (Not applicable)
Item Group
Section 5
C0015127 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Item
Possible Causes of SAE Other Than Investigational Product(s)
text
C0015127 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Possible Causes of SAE Other Than Investigational Product(s)
Code List
Possible Causes of SAE Other Than Investigational Product(s)
CL Item
Disease under study (1)
CL Item
Medical condition(s) (2)
CL Item
Lack of efficacy (3)
CL Item
Withdrawal of investigational product(s) (4)
CL Item
Concomitant medication(s) (5)
CL Item
Activity related to study participation (e.g., procedures) (6)
CL Item
Other (7)
If
Item
If "Medical condition(s)", specify:
text
C2348235 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
If "Concomitant medication(s)", specify:
Item
If "Concomitant medication(s)", specify:
text
C2348235 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
If "Other", specify:
Item
If "Other", specify:
text
C2348235 (UMLS CUI [1])
Item Group
SECTION 6: RELEVANT Medical Conditions
C0262926 (UMLS CUI-1)
Relevant Medical Conditions
Item
Specify any relevant past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE.
text
C0012634 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Date of onset
Item
Date of onset
date
C0574845 (UMLS CUI [1])
Item
Condition Present at Time of the SAE?
text
C0805733 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Condition Present at Time of the SAE
Code List
Condition Present at Time of the SAE?
CL Item
Yes (Y)
CL Item
No (N)
Date of Last Occurrence
Item
If No, Date of Last Occurrence
date
C0011008 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
Item Group
Section 7
Other risk factors relevant to SAE
Item
Other RELEVANT Risk Factors (provide any family or social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE)
integer
C0035648 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
SECTION 8 RELEVANT Concomitant Medications
C1828479 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Drug Name
Item
Drug Name
text
C0013227 (UMLS CUI [1])
Dose
Item
Dose
integer
C3174092 (UMLS CUI [1])
Unit
Item
Unit
text
C1519795 (UMLS CUI [1])
Frequency
Item
Frequency
text
C3476109 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1])
Taken Prior to Study?
Item
Taken Prior to Study?
boolean
C2826667 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Ongoing Medication?
Item
Ongoing Medication?
boolean
C2826666 (UMLS CUI [1])
Reason for Medication
Item
Reason for Medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item Group
Section 9 - Investigational Product
Record details of investigational product
Item
Record details of investigational product
text
Item Group
Section 10
Details of relevant assessments
Item
Details of RELEVANT Assessments (provide details of any other tests/procedures which were carried out to diagnose or confirm the SAE e.g., laboratory data with units and normal range)
text
C1261322 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
SECTION 11 Narrative Remarks
C1828479 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
Narrative Remarks
Item
Narrative Remarks (provide a brief narrative description of the SAE and details of treatment given)
text
C0947611 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Investigator's signature
C2346576 (UMLS CUI-1)
Investigator signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Investigator signature date
Item
Investigator signature date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator name
Item
Printed Investigator's name
text
C2826892 (UMLS CUI [1])
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