ID

38228

Beschrijving

Study ID: 109035 Clinical Study ID: 109035 Study Title: A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy and Safety of GSK163090 in Subjects With Major Depressive Disorder Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00896363 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK163090 1 mg, GSK163090 Placebo, GSK163090 3 mg Trade Name: Study Indication: Depressive Disorder

Trefwoorden

D003866

D016430

Adverse event

29-09-19 29-09-19 -
24-10-19 24-10-19 -

Houder van rechten

GlaxoSmithKline

Geüploaded op

29 september 2019

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0

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Efficacy and Safety of GSK163090 in Subjects with Major Depressive Disorder; NCT00896363

model
Details

Serious Adverse Events

1 Formulieren

StudyEvent: ODM
1. Serious Adverse Events

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

Administrative documentation

Item Group

Administrative Data

C1320722 (UMLS CUI-1)

Study Site

Item

Site

text

C2825164 (UMLS CUI [1])

Patient name

Item

Patient

text

C1299487 (UMLS CUI [1])

Patients, Identification number

Item

Patient No

integer

C0030705 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])

Serious Adverse Event, Report, Type

Item Group

Type of Report

C1519255 (UMLS CUI-1)
C0684224 (UMLS CUI-2)
C0332307 (UMLS CUI-3)

Serious Adverse Event, Report, Type

Item

Type of Report

text

C1519255 (UMLS CUI [1,1])
C0684224 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])

Serious Adverse Event, Report, Type

Code List

Type of Report

CL Item

Initial Report (1)

CL Item

Follow-Up Report (2)

Serious Adverse Event, Randomization

Item Group

Randomisation

C1519255 (UMLS CUI-1)
C0034656 (UMLS CUI-2)

Serious Adverse Event, Experimental drug

Item

Did SAE occur after initiation of study medication?

boolean

C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])

Serious Adverse Event

Item Group

Serious Adverse Event

C1519255 (UMLS CUI-1)

Serious Adverse Event, Sequence Number

Item

SAE Sequence Number

integer

C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])

Serious Adverse Event

Item

Serious Adverse Event Diagnosis Only (if known) Otherwise Sign/Symptom

text

C1519255 (UMLS CUI [1])

Serious Adverse Event, Adverse Event Modified Reported Term

Item

Modified term

text

C1519255 (UMLS CUI [1,1])
C2826798 (UMLS CUI [1,2])

Serious Adverse Event, Medical Dictionary for Regulatory Activities Terminology (MedDRA)

Item

MedDRA synonym

text

C1519255 (UMLS CUI [1,1])
C1140263 (UMLS CUI [1,2])

Serious Adverse Event, MedDRA Low Level Term Code

Item

MedDRA lower level term code

text

C1519255 (UMLS CUI [1,1])
C3898442 (UMLS CUI [1,2])

Serious Adverse Event, Code, Failed

Item

Failed coding

text

C1519255 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])

Serious Adverse Event, Start Date, Start time

Item

Start Date and Time

datetime

C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])

Serious Adverse Event, Adverse Event Outcome

Item

Outcome

text

C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])

Non-serious Adverse Event, Adverse Event Outcome

Code List

Outcome

CL Item

Recovered/Resolved, provide End Date (1)

CL Item

Recovering/Resolving (2)

CL Item

Not recovered/Not resolved (3)

CL Item

Recovered/Resolved with sequelae, provide End Date (4)

CL Item

Fatal, record Date of Death (5)

Serious Adverse Event, End Date; Serious Adverse Event, Date of death

Item

End Date/Date of Death

date

C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C1148348 (UMLS CUI [2,2])

Non-serious Adverse Event, Frequencies

Item

Frequency

text

C1518404 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])

Non-serious Adverse Event, Frequencies

Code List

Frequency

CL Item

Single Episode (1)

CL Item

Intermittent (2)

Serious Adverse Event, Severity of Adverse Event

Item

Maximum Intensity

text

C1519255 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])

Non-serious Adverse Event, Severity of Adverse Event

Code List

Maximum Intensity

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

CL Item

Not applicable (4)

Serious Adverse Event, Symptom intensity, Date of onset

Item

Intensity at onset of event

text

C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,3])

Non-serious Adverse Event, Symptom intensity, Date of onset

Code List

Intensity at onset of event

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

CL Item

Not applicable (4)

Serious Adverse Event, Grade, Maximum

Item

Maximum Grade

text

C1519255 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])

Non-serious Adverse Event, Grade, Maximum

Code List

Maximum Grade

CL Item

Grade 1 (1)

CL Item

Grade 2 (2)

CL Item

Grade 3 (3)

CL Item

Grade 4 (4)

CL Item

Grade 5 (5)

Serious Adverse Event, Grade, Date of onset

Item

Grade at onset of event

text

C1519255 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,3])

Non-serious Adverse Event, Grade, Date of onset

Code List

Grade at onset of event

CL Item

Grade 1 (1)

CL Item

Grade 2 (2)

CL Item

Grade 3 (3)

CL Item

Grade 4 (4)

CL Item

Grade 5 (5)

Serious Adverse Event, Grade, Symptom intensity, Maximum

Item

Maximum Grade or Intensity

text

C1519255 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
C0806909 (UMLS CUI [1,4])

Non-serious Adverse Event, Grade, Symptom intensity, Maximum

Code List

Maximum Grade or Intensity

CL Item

Mild or Grade 1 (1)

CL Item

Moderate or Grade 2 (2)

CL Item

Severe or Grade 3 (3)

CL Item

Grade 4 (4)

CL Item

Grade 5 (5)

CL Item

Not applicable (6)

Serious Adverse Event, Grade, Symptom intensity, Date of onset

Item

Grade or Intensity at onset of event

text

C1519255 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
C0574845 (UMLS CUI [1,4])

Non-serious Adverse Event, Grade, Symptom intensity, Date of onset

Code List

Grade or Intensity at onset of event

CL Item

Mild or Grade 1 (1)

CL Item

Moderate or Grade 2 (2)

CL Item

Severe or Grade 3 (3)

CL Item

Grade 4 (4)

CL Item

Grade 5 (5)

CL Item

Not applicable (6)

Serious Adverse Event, Action Taken with Study Treatment

Item

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

text

C1519255 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])

Non-serious Adverse Event, Action Taken with Study Treatment

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)

Serious Adverse Event, Withdraw

Item

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

boolean

C1519255 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])

Serious Adverse Event, Relationships, Experimental drug

Item

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

boolean

C1519255 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])

Serious Adverse Event, Duration

Item

Duration of AE if < 24 hours

time

C1519255 (UMLS CUI [1,1])
C2926735 (UMLS CUI [1,2])

Serious Adverse Event, Time Last Dose

Item

Time to Onset Since Last Dose

time

C1519255 (UMLS CUI [1,1])
C0946444 (UMLS CUI [1,2])

Serious Adverse Event, Relationship, Study Subject Participation Status

Item

Was the SAE caused by activities related to study participation other than investigational product (e.g. procedures, blood draws, washout, etc)?

boolean

C1519255 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])

Serious Adverse Event

Item

Was the event serious?

boolean

C1519255 (UMLS CUI [1])

Serious Adverse Event, Relationship, Experimental drug

Item

Related Investigational Product

text

C1519255 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])

Serious Adverse Event, Symptom intensity, Changing

Item Group

Intensity Changes

C1519255 (UMLS CUI-1)
C0518690 (UMLS CUI-2)
C0392747 (UMLS CUI-3)

Serious Adverse Event

Item

Serious Adverse Event Diagnosis Only (if known) Otherwise Sign/ Symptom

text

C1519255 (UMLS CUI [1])

Serious Adverse Event, Part, Start Date, Start time

Item

Start Date and Time of event segment

datetime

C1519255 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C1301880 (UMLS CUI [1,4])

Serious Adverse Event, Part, Symptom intensity

Item

Intensity of event segment

text

C1519255 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])

Non-serious Adverse Event, Part, Symptom intensity

Code List

Intensity of event segment

CL Item

Mild (1)

CL Item

Moderate (2)

CL Item

Severe (3)

Serious Adverse Event, Part, Grade

Item

Grade of event segment

text

C1519255 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])

Non-serious Adverse Event, Part, Grade

Code List

Grade of event segment

CL Item

Grade 1 (1)

CL Item

Grade 2 (2)

CL Item

Grade 3 (3)

CL Item

Grade 4 (4)

CL Item

Grade 5 (5)

Serious Adverse Event, Part, Symptom intensity, Grade

Item

Grade or Intensity of event segment

text

C1519255 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,4])

Non-serious Adverse Event, Part, Symptom intensity, Grade

Code List

Grade or Intensity of event segment

CL Item

Mild or Grade 1 (1)

CL Item

Moderate or Grade 2 (2)

CL Item

Severe or Grade 3 (3)

CL Item

Grade 4 (4)

CL Item

Grade 5 (5)

Serious Adverse Event, Severity of Adverse Event

Item Group

Seriousness

C1519255 (UMLS CUI-1)
C1710066 (UMLS CUI-2)

Serious Adverse Event, Severity of Adverse Event

Item

Seriousness?

text

C1519255 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])

Serious Adverse Event, Severity of Adverse Event

Code List

Seriousness?

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, specify within general narrative comment (6)

Serious Adverse Event, Concomitant Agent

Item Group

Relevant Concomitant/Treatment Medications

C1519255 (UMLS CUI-1)
C2347852 (UMLS CUI-2)

Serous Adverse Event, Concomitant Agent, Sequence Number

Item

CM Sequence Number

integer

C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,3])

Serous Adverse Event, Concomitant Agent, Medication name

Item

Drug name

text

C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])

Serous Adverse Event, Concomitant Agent, Adverse Event Modified Reported Term

Item

Modified reported term

text

C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2826819 (UMLS CUI [1,3])

Serous Adverse Event, Concomitant Agent, Medication dose

Item

Dose

text

C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])

Serous Adverse Event, Concomitant Agent, Unit

Item

Unit

text

C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0439148 (UMLS CUI [1,3])

Serous Adverse Event, Concomitant Agent, Frequencies

Item

Frequency

text

C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])

Serous Adverse Event, Concomitant Agent, Drug Administration Routes

Item

Route

text

C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])

Serous Adverse Event, Concomitant Medication Start Date

Item

Start Date

date

C1519255 (UMLS CUI [1,1])
C2826734 (UMLS CUI [1,2])

Serous Adverse Event, Concomitant Medication Ongoing

Item

Ongoing?

boolean

C1519255 (UMLS CUI [1,1])
C2826666 (UMLS CUI [1,2])

Serous Adverse Event, Concomitant Medication Ongoing

Item

No, specify End Date

date

C1519255 (UMLS CUI [1,1])
C2826744 (UMLS CUI [1,2])

Serous Adverse Event, Concomitant Agent, Indication

Item

Primary Indication

text

C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])

Serous Adverse Event, Concomitant Agent, Adverse Event Modified Reported Term

Item

Modified reported term

text

C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2826798 (UMLS CUI [1,3])

Serous Adverse Event, Concomitant Agent, Type

Item

Drug Type

text

C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])

Serious Adverse Event, Disease, Risk factor

Item Group

Relevant Medical Conditions / Risk Factors

C1519255 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
C0035648 (UMLS CUI-3)

Serious Adverse Event, Disease, Sequence Number

Item

MHx Sequence Number

integer

C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,3])

Serious Adverse Event, Disease

Item

Specific Condition Name

text

C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])

Serious Adverse Event, Disease, Adverse Event Modified Reported Term

Item

Modified reported term

text

C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C2826798 (UMLS CUI [1,3])

Serious Adverse Event, Disease, Start Date

Item

Date of onset

date

C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])

Serious Adverse Event, Disease, Continuous

Item

Continuing?

text

C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])

Serious Adverse Event, Disease, Continuous

Code List

Continuing?

CL Item

Yes (1)

CL Item

No (2)

CL Item

Unknown (3)

Serious Adverse Event, Disease, End Date

Item

No, specify date of last occurrence

date

C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])

Serious Adverse Event, Disease, Risk factor

Item

Relevant Medical History / Risk Factors not noted above

text

C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0035648 (UMLS CUI [1,3])

Serious Adverse Event, Diagnostic procedure, Result

Item Group

Relevant Diagnostic Results

C1519255 (UMLS CUI-1)
C0430022 (UMLS CUI-2)
C1274040 (UMLS CUI-3)

Serious Adverse Event, Laboratory Procedures, Sequence Number

Item

Lab Sequence Number

integer

C1519255 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,3])

Serious Adverse Event, Diagnostic procedure

Item

Test Name

text

C1519255 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])

Serious Adverse Event, Diagnostic procedure, Date in time

Item

Test Date

date

C1519255 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])

Serious Adverse Event, Diagnostic procedure, Result

Item

Test Result

text

C1519255 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])

Serious Adverse Event, Diagnostic procedure, Unit of Measure

Item

Test Units

text

C1519255 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])

Serious Adverse Event, Diagnostic procedure, Normal Range, Low

Item

Normal Low Range

text

C1519255 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C0086715 (UMLS CUI [1,3])
C0205251 (UMLS CUI [1,4])

Serious Adverse Event, Diagnostic procedure, Normal Range, High

Item

Normal High Range

text

C1519255 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C0086715 (UMLS CUI [1,3])
C0205250 (UMLS CUI [1,4])

Serious Adverse Event, Diagnostic procedure, Result, Other

Item

Relevant diagnostic results not noted above

text

C1519255 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])

Serious Adverse Event, Rechallenge

Item Group

Rechallenge

C1519255 (UMLS CUI-1)
C2347900 (UMLS CUI-2)

Serious Adverse Event, Rechallenge

Item

If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?

text

C1519255 (UMLS CUI [1,1])
C2347900 (UMLS CUI [1,2])

Serious Adverse Event, Rechallenge

Code List

If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?

CL Item

No (1)

CL Item

Yes (2)

CL Item

Unknown at this time (3)

CL Item

Not applicable (4)

Serious Adverse Event, Experimental drug

Item Group

Investigational Product

C1519255 (UMLS CUI-1)
C0304229 (UMLS CUI-2)

Serious Adverse Event, Experimental drug

Item

Study Drug

text

C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])

Serious Adverse Event, Experimental drug, Start Date

Item

Start Date

date

C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])

Serious Adverse Event, Experimental drug, End Date

Item

Stop Date

date

C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])

Serious Adverse Event, Experimental drug, Dosage

Item

Dose

text

C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])

Serious Adverse Event, Experimental drug, Cumulative dose

Item

Cumulative Dose

text

C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C2986497 (UMLS CUI [1,3])

Serious Adverse Event, Experimental drug, Therapeutic regimen

Item

Regimen

text

C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1276413 (UMLS CUI [1,3])

Serious Adverse Event, Comment

Item Group

General Narrative Comments

C1519255 (UMLS CUI-1)
C0947611 (UMLS CUI-2)

Serious Adverse Event, Comment

Item

Provide a brief narrative description of SAE, possible other causes of the event (e.g. lack of efficacy, withdrawal of investigational product, the disease under study or other medical conditions) and details of the treatment.

text

C1519255 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])

Serious Adverse Event, Non-clinical Overview

Item Group

Non Clinical

C1519255 (UMLS CUI-1)
C2698490 (UMLS CUI-2)

Serious Adverse Event, Data, Incomplete

Item

Send incomplete SAE data to GSK Safety

text

C1519255 (UMLS CUI [1,1])
C1511726 (UMLS CUI [1,2])
C0205257 (UMLS CUI [1,3])

Serious Adverse Event, Data, Incomplete

Code List

Send incomplete SAE data to GSK Safety

CL Item

Incomplete SAE (1)

Serious Adverse Event, Receipt, Date in time, Time

Item

Receipt by GSK date

datetime

C1519255 (UMLS CUI [1,1])
C2985846 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])

Serious Adverse Event

Item

Was the event serious?

boolean

C1519255 (UMLS CUI [1])

Serious Adverse Event, Sequence Number

Item

SAE Sequence Number

integer

C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])

Serious Adverse Event, Version, Numbers

Item

Version Number

integer

C1519255 (UMLS CUI [1,1])
C0333052 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])

Serious Adverse Event, Case Subject, Identifier

Item

Case ID

integer

C1519255 (UMLS CUI [1,1])
C1698493 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])

Serious Adverse Event, Randomization, Numbers

Item

Randomisation Number

integer

C1519255 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])

Serious Adverse Event, Code

Item

OCEANS Code

text

C1519255 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])

Serious Adverse Event, Email

Item

Email Flag

text

C1519255 (UMLS CUI [1,1])
C0013849 (UMLS CUI [1,2])

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Efficacy and Safety of GSK163090 in Subjects with Major Depressive Disorder; NCT00896363

Serious Adverse Events

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