Evaluating the Safety, Tolerability, and Pharmacokinetics... | NCT02178800

ID	Type	Description	Link
11964	Registry Identifier	DAIDS ES

Label	Type	Description	Intervention Names
Group 1: GSK1265744	Experimental	Participants in Cohorts 1 and 2 will receive one GSK1265744 tablet orally every day from study entry through Week 4. They will then receive an injection of GSK1265744-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.	Drug: GSK1265744 Tablets Drug: Injectable GSK1265744
Group 2: Placebo	Placebo Comparator	Participants in Cohorts 1 and 2 will receive one placebo tablet orally every day from study entry through Week 4. They will then receive an injection of placebo-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.	Drug: Placebo for GSK1265744 Tablets Drug: Injectable Placebo for GSK1265744

Name	Type	Description	Arm Group Labels	Other Names
GSK1265744 Tablets	Drug	30-mg tablets, taken orally	Group 1: GSK1265744

Measure	Description	Time Frame
Number of Participants Experiencing Any Grade 2 or Higher Clinical Adverse Events (AEs) and Laboratory Abnormalities That Occur From the Initial Injection to Week 41 Among Participants Who Receive at Least One Injection (Injectable Phase Only)	An adverse events (AE) or laboratory abnormality can be an unfavorable or unintended sign, symptom or disease temporally associated with the use of an investigational product, whether or not considered related to the product. AE severity was graded per the DAIDS Table for Grading Adult and Pediatric Adverse Events, Version 2.0, November 2014. The outcome in this table is stratified by arm.	Measured through Week 41
Number of Participants Who Discontinue Injectable Study Product for Reasons of Toxicity, Tolerability, or Acceptability That Occur From the Initial Injection to Week 41 Among Participants Who Receive at Least One Injection (Injectable Phase Only)	Stratified by arm	Measured through Week 41
Plasma Drug Levels of GSK1265744 at Designated Time Points After Each Injection of 744LA (Injectable Formulation of GSK1265744)	Geometric means and 90% prediction intervals by sex at birth and cohort are reported.	Measured through Week 41

Measure	Description	Time Frame
Number of Participants Experiencing Grade 2 or Higher Clinical Adverse Events (AEs) and Laboratory Abnormalities During Tail Phase	An adverse events (AE) or laboratory abnormality can be an unfavorable or unintended sign, symptom or disease temporally associated with the use of an investigational product, whether or not considered related to the product. AE severity was graded per the DAIDS Table for Grading Adult and Pediatric Adverse Events, Version 2.0, November 2014. The outcome in this table is stratified by arm.

Name	Affiliation	Role
Raphael J. Landovitz, MD, MSc	University of California, Los Angeles	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
UCLA CARE Center CRS		Los Angeles	California	90035	United States
Bridge HIV CRS

PubMed Identifier	Type	Citation	Retractions
32497491	Derived	Landovitz RJ, Li S, Eron JJ Jr, Grinsztejn B, Dawood H, Liu AY, Magnus M, Hosseinipour MC, Panchia R, Cottle L, Chau G, Richardson P, Marzinke MA, Eshleman SH, Kofron R, Adeyeye A, Burns D, Rinehart AR, Margolis D, Cohen MS, McCauley M, Hendrix CW. Tail-phase safety, tolerability, and pharmacokinetics of long-acting injectable cabotegravir in HIV-uninfected adults: a secondary analysis of the HPTN 077 trial. Lancet HIV. 2020 Jul;7(7):e472-e481. doi: 10.1016/S2352-3018(20)30106-5. Epub 2020 Jun 1.
30408115

ID	Title	Description
FG000	Group 1: GSK1265744	Participants in Cohorts 1 and 2 will receive one GSK1265744 tablet orally every day from study entry through Week 4. They will then receive an injection of GSK1265744-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2. GSK1265744 Tablets: 30-mg tablets, taken orally Injectable GSK1265744: Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections Cohort 2: 600-mg injection, administered as one IM gluteal injection

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 13, 2015	Apr 26, 2018

ID	Title	Description
BG000	Group 1: GSK1265744	Participants in Cohorts 1 and 2 will receive one GSK1265744 tablet orally every day from study entry through Week 4. They will then receive an injection of GSK1265744-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2. GSK1265744 Tablets: 30-mg tablets, taken orally Injectable GSK1265744: Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections Cohort 2: 600-mg injection, administered as one IM gluteal injection
BG001	Group 2: Placebo	Participants in Cohorts 1 and 2 will receive one placebo tablet orally every day from study entry through Week 4. They will then receive an injection of placebo-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2. Placebo for GSK1265744 Tablets: Taken orally Injectable Placebo for GSK1265744: Cohort 1: Sodium Chloride for Injection USP, 0.9%; administered as two 400-mg IM gluteal injections Cohort 2: Sodium Chloride for Injection USP, 0.9%; administered as one 600-mg IM gluteal injection
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000151 BG00148 BG002199

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants Experiencing Any Grade 2 or Higher Clinical Adverse Events (AEs) and Laboratory Abnormalities That Occur From the Initial Injection to Week 41 Among Participants Who Receive at Least One Injection (Injectable Phase Only)

An adverse events (AE) or laboratory abnormality can be an unfavorable or unintended sign, symptom or disease temporally associated with the use of an investigational product, whether or not considered related to the product. AE severity was graded per the DAIDS Table for Grading Adult and Pediatric Adverse Events, Version 2.0, November 2014. The outcome in this table is stratified by arm.

This population includes participants who receive at least one injection in the study.

Posted

Count of Participants

Participants

Measured through Week 41

ID	Title	Description
OG000	Group 1: GSK1265744	Participants in Cohorts 1 and 2 will receive one GSK1265744 tablet orally every day from study entry through Week 4. They will then receive an injection of GSK1265744-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2. GSK1265744 Tablets: 30-mg tablets, taken orally Injectable GSK1265744: Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections Cohort 2: 600-mg injection, administered as one IM gluteal injection
OG001	Group 2: Placebo	Participants in Cohorts 1 and 2 will receive one placebo tablet orally every day from study entry through Week 4. They will then receive an injection of placebo-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2. Placebo for GSK1265744 Tablets: Taken orally Injectable Placebo for GSK1265744: Cohort 1: Sodium Chloride for Injection USP, 0.9%; administered as two 400-mg IM gluteal injections Cohort 2: Sodium Chloride for Injection USP, 0.9%; administered as one 600-mg IM gluteal injection

Units	Counts
Participants	OG000134 OG00143

Title

Denominators

Categories

Title	Measurements
	OG000121 OG00138

Primary

Number of Participants Who Discontinue Injectable Study Product for Reasons of Toxicity, Tolerability, or Acceptability That Occur From the Initial Injection to Week 41 Among Participants Who Receive at Least One Injection (Injectable Phase Only)

Stratified by arm

This population includes participants who received at least one injection in the study.

Posted

Count of Participants

Participants

Measured through Week 41

ID	Title	Description
OG000	Group 1: GSK1265744	Participants in Cohorts 1 and 2 will receive one GSK1265744 tablet orally every day from study entry through Week 4. They will then receive an injection of GSK1265744-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2. GSK1265744 Tablets: 30-mg tablets, taken orally Injectable GSK1265744: Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections Cohort 2: 600-mg injection, administered as one IM gluteal injection
OG001	Group 2: Placebo	Participants in Cohorts 1 and 2 will receive one placebo tablet orally every day from study entry through Week 4. They will then receive an injection of placebo-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2. Placebo for GSK1265744 Tablets: Taken orally Injectable Placebo for GSK1265744: Cohort 1: Sodium Chloride for Injection USP, 0.9%; administered as two 400-mg IM gluteal injections Cohort 2: Sodium Chloride for Injection USP, 0.9%; administered as one 600-mg IM gluteal injection

Primary

Plasma Drug Levels of GSK1265744 at Designated Time Points After Each Injection of 744LA (Injectable Formulation of GSK1265744)

Geometric means and 90% prediction intervals by sex at birth and cohort are reported.

PK sample size varies by visit due to reasons such as missing visits, different schedule and sample contamination.

Posted

Geometric Mean

90% Confidence Interval

ug/ml

Measured through Week 41

ID	Title	Description
OG000	Female, Cohort 1	Female, GSK1265744 arm, Cohort 1 participants who received at least one injection only. Plasma drug concentrations at Week 6, 9,13,17,18,23,29,30,35 and 41 are measured.
OG001	Male, Cohort 1	Male, GSK1265744 arm, Cohort 1 participants who received at least one injection only. Plasma drug concentrations at Week 6, 9,13,17,18,23,29,30,35 and 41 are measured.
OG002	Female, Cohort 2	Female, GSK1265744 arm, Cohort 2 participants who received at least one injection only. Plasma drug concentrations at Week 6, 9,10,13,17,18,21,25,26,29,33,34,37 and 41 are measured.
OG003	Male, Cohort 2

Secondary

Number of Participants Experiencing Grade 2 or Higher Clinical Adverse Events (AEs) and Laboratory Abnormalities During Tail Phase

This includes participants who entered tail phase

Posted

Count of Participants

Participants

Measured from 12 weeks after last injection through Week 105 for Cohort 1 and 8 weeks after last injection through Week 109 for Cohort 2

ID	Title	Description
OG000	Group 1: GSK1265744	Participants in Cohorts 1 and 2 will receive one GSK1265744 tablet orally every day from study entry through Week 4. They will then receive an injection of GSK1265744-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2. GSK1265744 Tablets: 30-mg tablets, taken orally Injectable GSK1265744: Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections Cohort 2: 600-mg injection, administered as one IM gluteal injection
OG001	Group 2: Placebo	Participants in Cohorts 1 and 2 will receive one placebo tablet orally every day from study entry through Week 4. They will then receive an injection of placebo-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2. Placebo for GSK1265744 Tablets: Taken orally Injectable Placebo for GSK1265744: Cohort 1: Sodium Chloride for Injection USP, 0.9%; administered as two 400-mg IM gluteal injections Cohort 2: Sodium Chloride for Injection USP, 0.9%; administered as one 600-mg IM gluteal injection

Secondary

Number of Participants Experiencing Grade 2 or Higher Clinical Adverse Events (AEs) and Laboratory Abnormalities Prior to Completion of the Oral Phase

Posted

Count of Participants

Participants

Measured through Week 5

ID	Title	Description
OG000	Group 1: GSK1265744	Participants in Cohorts 1 and 2 will receive one GSK1265744 tablet orally every day from study entry through Week 4. They will then receive an injection of GSK1265744-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2. GSK1265744 Tablets: 30-mg tablets, taken orally Injectable GSK1265744: Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections Cohort 2: 600-mg injection, administered as one IM gluteal injection
OG001	Group 2: Placebo	Participants in Cohorts 1 and 2 will receive one placebo tablet orally every day from study entry through Week 4. They will then receive an injection of placebo-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2. Placebo for GSK1265744 Tablets: Taken orally Injectable Placebo for GSK1265744: Cohort 1: Sodium Chloride for Injection USP, 0.9%; administered as two 400-mg IM gluteal injections Cohort 2: Sodium Chloride for Injection USP, 0.9%; administered as one 600-mg IM gluteal injection

Secondary

Number of Participants Willing to Use an Injectable Agent Such as the Study Product for HIV Prevention in the Future

Stratified by Visit and Cohort

Sample size varies by visit due to reasons such as missing visits and different schedules.

Posted

Count of Participants

Participants

Measured from week 6 through Week 30 in cohort 1 and Week 34 in cohort 2

ID	Title	Description
OG000	Cohort 1	Participants who were planned to receive IM injections of 744LA or placebo at three time points at 12 week intervals.Two sequential 400 mg gluteal injections were given at each injection visit (if not discontinued).
OG001	Cohort 2	participants who were planned to receive IM injections of 744LA or placebo at five time points at 4 and 8 week intervals.One 600 mg gluteal injection was given at each injection visit (if not discontinued).

Units	Counts
Participants	OG000

Secondary

Number of Participants With HIV Infections Through the Study Period, Stratified by Arm

Posted

Count of Participants

Participants

Measured through Week 105 for Cohort 1 and Week 109 for Cohort 2

ID	Title	Description
OG000	Group 1: GSK1265744	Participants in Cohorts 1 and 2 will receive one GSK1265744 tablet orally every day from study entry through Week 4. They will then receive an injection of GSK1265744-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2. GSK1265744 Tablets: 30-mg tablets, taken orally Injectable GSK1265744: Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections Cohort 2: 600-mg injection, administered as one IM gluteal injection
OG001	Group 2: Placebo	Participants in Cohorts 1 and 2 will receive one placebo tablet orally every day from study entry through Week 4. They will then receive an injection of placebo-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2. Placebo for GSK1265744 Tablets: Taken orally Injectable Placebo for GSK1265744: Cohort 1: Sodium Chloride for Injection USP, 0.9%; administered as two 400-mg IM gluteal injections Cohort 2: Sodium Chloride for Injection USP, 0.9%; administered as one 600-mg IM gluteal injection

Secondary

Self-reported Sexual Behavior (Number of Sexual Partners) During the Study Period

Week 29/31 is a combination of week 29, cohort 1 and week 33, cohort 2. The outcome in this table is stratified by arm.

Analysis sample size is different at each visit due to multiple reasons (early termination, missing data, study unblinding, etc.)

Posted

Mean

Standard Deviation

partners

Measured through Week 77

ID	Title	Description
OG000	Group 1: GSK1265744	Participants in Cohorts 1 and 2 will receive one GSK1265744 tablet orally every day from study entry through Week 4. They will then receive an injection of GSK1265744-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2. GSK1265744 Tablets: 30-mg tablets, taken orally Injectable GSK1265744: Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections Cohort 2: 600-mg injection, administered as one IM gluteal injection
OG001	Group 2: Placebo	Participants in Cohorts 1 and 2 will receive one placebo tablet orally every day from study entry through Week 4. They will then receive an injection of placebo-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2. Placebo for GSK1265744 Tablets: Taken orally Injectable Placebo for GSK1265744: Cohort 1: Sodium Chloride for Injection USP, 0.9%; administered as two 400-mg IM gluteal injections Cohort 2: Sodium Chloride for Injection USP, 0.9%; administered as one 600-mg IM gluteal injection

Secondary

Number of Injectable Hormonal-contraception-using Female Participants Experiencing Grade 2 or Higher Clinical AE and Laboratory Abnormalities During Oral Phase

This population includes injectable hormonal-contraception-using female participants in the study

Posted

Count of Participants

Participants

Measured through Week 4

ID	Title	Description
OG000	Group 1: GSK1265744	Participants in Cohorts 1 and 2 will receive one GSK1265744 tablet orally every day from study entry through Week 4. They will then receive an injection of GSK1265744-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2. GSK1265744 Tablets: 30-mg tablets, taken orally Injectable GSK1265744: Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections Cohort 2: 600-mg injection, administered as one IM gluteal injection
OG001	Group 2: Placebo	Participants in Cohorts 1 and 2 will receive one placebo tablet orally every day from study entry through Week 4. They will then receive an injection of placebo-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2. Placebo for GSK1265744 Tablets: Taken orally Injectable Placebo for GSK1265744: Cohort 1: Sodium Chloride for Injection USP, 0.9%; administered as two 400-mg IM gluteal injections Cohort 2: Sodium Chloride for Injection USP, 0.9%; administered as one 600-mg IM gluteal injection

Secondary

Number of Injectable Hormonal-contraception-using Female Participants Experiencing Grade 2 or Higher Clinical AE and Laboratory Abnormalities During Injection Phase

This population includes injectable hormonal-contraception-using female participants who received at least one injection of study drug in the study

Posted

Count of Participants

Participants

Measured from first injection through 12 weeks after last injection for Cohort 1 and 8 weeks after last injection for Cohort 2

ID	Title	Description
OG000	Group 1: GSK1265744	Participants in Cohorts 1 and 2 will receive one GSK1265744 tablet orally every day from study entry through Week 4. They will then receive an injection of GSK1265744-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2. GSK1265744 Tablets: 30-mg tablets, taken orally Injectable GSK1265744: Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections Cohort 2: 600-mg injection, administered as one IM gluteal injection
OG001	Group 2: Placebo	Participants in Cohorts 1 and 2 will receive one placebo tablet orally every day from study entry through Week 4. They will then receive an injection of placebo-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2. Placebo for GSK1265744 Tablets: Taken orally Injectable Placebo for GSK1265744: Cohort 1: Sodium Chloride for Injection USP, 0.9%; administered as two 400-mg IM gluteal injections Cohort 2: Sodium Chloride for Injection USP, 0.9%; administered as one 600-mg IM gluteal injection

Secondary

Number of Injectable Hormonal-contraception-using Female Participants Who Discontinue Study Product for Reasons of Toxicity, Tolerability, or Acceptability During Oral Phase

Stratified by arm

This population includes injectable hormonal-contraception-using female participants in the study

Posted

Count of Participants

Participants

Measured through Week 4

ID	Title	Description
OG000	Group 1: GSK1265744	Participants in Cohorts 1 and 2 will receive one GSK1265744 tablet orally every day from study entry through Week 4. They will then receive an injection of GSK1265744-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2. GSK1265744 Tablets: 30-mg tablets, taken orally Injectable GSK1265744: Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections Cohort 2: 600-mg injection, administered as one IM gluteal injection
OG001	Group 2: Placebo	Participants in Cohorts 1 and 2 will receive one placebo tablet orally every day from study entry through Week 4. They will then receive an injection of placebo-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2. Placebo for GSK1265744 Tablets: Taken orally Injectable Placebo for GSK1265744: Cohort 1: Sodium Chloride for Injection USP, 0.9%; administered as two 400-mg IM gluteal injections Cohort 2: Sodium Chloride for Injection USP, 0.9%; administered as one 600-mg IM gluteal injection

Secondary

Number of Injectable Hormonal-contraception-using Female Participants Who Discontinue Study Product for Reasons of Toxicity, Tolerability, or Acceptability During Injection Phase

This population includes injectable hormonal-contraception-using female participants who received at least one injection of study drug in the study

Posted

Count of Participants

Participants

Measured from first injection through 12 weeks after last injection for Cohort 1 and 8 weeks after last injection for Cohort 2

ID	Title	Description
OG000	Group 1: GSK1265744	Participants in Cohorts 1 and 2 will receive one GSK1265744 tablet orally every day from study entry through Week 4. They will then receive an injection of GSK1265744-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2. GSK1265744 Tablets: 30-mg tablets, taken orally Injectable GSK1265744: Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections Cohort 2: 600-mg injection, administered as one IM gluteal injection
OG001	Group 2: Placebo	Participants in Cohorts 1 and 2 will receive one placebo tablet orally every day from study entry through Week 4. They will then receive an injection of placebo-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2. Placebo for GSK1265744 Tablets: Taken orally Injectable Placebo for GSK1265744: Cohort 1: Sodium Chloride for Injection USP, 0.9%; administered as two 400-mg IM gluteal injections Cohort 2: Sodium Chloride for Injection USP, 0.9%; administered as one 600-mg IM gluteal injection

Secondary

Number of Participants Who Discontinue Oral Study Product for Reasons of Toxicity, Tolerability, or Acceptability Prior to Completion of the Oral Phase

Stratified by arm

Posted

Count of Participants

Participants

Measured through Week 4

ID	Title	Description
OG000	Group 1: GSK1265744	Participants in Cohorts 1 and 2 will receive one GSK1265744 tablet orally every day from study entry through Week 4. They will then receive an injection of GSK1265744-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2. GSK1265744 Tablets: 30-mg tablets, taken orally Injectable GSK1265744: Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections Cohort 2: 600-mg injection, administered as one IM gluteal injection
OG001	Group 2: Placebo	Participants in Cohorts 1 and 2 will receive one placebo tablet orally every day from study entry through Week 4. They will then receive an injection of placebo-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2. Placebo for GSK1265744 Tablets: Taken orally Injectable Placebo for GSK1265744: Cohort 1: Sodium Chloride for Injection USP, 0.9%; administered as two 400-mg IM gluteal injections Cohort 2: Sodium Chloride for Injection USP, 0.9%; administered as one 600-mg IM gluteal injection

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Abdominal discomfort	Gastrointestinal disorders	Non-systematic Assessment	EG0003 events2 affected151 at risk EG0010 events0 affected48 at risk
Abdominal distension	Gastrointestinal disorders	Non-systematic Assessment	EG0002 events2 affected151 at risk EG0010 events0 affected48 at risk
Abdominal pain	Gastrointestinal disorders	Non-systematic Assessment	EG0009 events7 affected151 at risk EG0010 events0 affected48 at risk
Abdominal pain lower	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected48 at risk
Abdominal pain upper	Gastrointestinal disorders	Non-systematic Assessment	EG0004 events3 affected151 at risk EG0011 events1 affected48 at risk
Abnormal dreams	Psychiatric disorders	Non-systematic Assessment	EG00012 events8 affected151 at risk EG0014 events4 affected48 at risk
Abnormal loss of weight	Metabolism and nutrition disorders	Non-systematic Assessment	EG0005 events4 affected151 at risk EG0010 events0 affected48 at risk
Acne	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0003 events3 affected151 at risk EG0011 events1 affected48 at risk
Acute sinusitis	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Alanine aminotransferase increased	Investigations	Non-systematic Assessment	EG00026 events18 affected151 at risk EG0018 events5 affected48 at risk
Allergic pharyngitis	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Allergic sinusitis	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0003 events3 affected151 at risk EG0010 events0 affected48 at risk
Amylase decreased	Investigations	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Amylase increased	Investigations	Non-systematic Assessment	EG00032 events18 affected151 at risk EG00110 events5 affected48 at risk
Anaemia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0002 events1 affected151 at risk EG0010 events0 affected48 at risk
Anal fissure	Gastrointestinal disorders	Non-systematic Assessment	EG0002 events1 affected151 at risk EG0010 events0 affected48 at risk
Angioedema	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0002 events2 affected151 at risk EG0010 events0 affected48 at risk
Anxiety	Psychiatric disorders	Non-systematic Assessment	EG0004 events4 affected151 at risk EG0011 events1 affected48 at risk
Anxiety disorder	Psychiatric disorders	Non-systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected48 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG00013 events11 affected151 at risk EG0013 events3 affected48 at risk
Arthritis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Arthrofibrosis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Arthropod bite	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0002 events2 affected151 at risk EG0010 events0 affected48 at risk
Aspartate aminotransferase increased	Investigations	Non-systematic Assessment	EG00018 events13 affected151 at risk EG0014 events3 affected48 at risk
Back pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG00018 events16 affected151 at risk EG0013 events3 affected48 at risk
Bacterial vaginosis	Infections and infestations	Non-systematic Assessment	EG0003 events3 affected151 at risk EG0012 events2 affected48 at risk
Balanoposthitis	Reproductive system and breast disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0002 events1 affected151 at risk EG0010 events0 affected48 at risk
Bilirubin conjugated increased	Investigations	Non-systematic Assessment	EG00010 events7 affected151 at risk EG0011 events1 affected48 at risk
Blister	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Blood alkaline phosphatase increased	Investigations	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0011 events1 affected48 at risk
Blood bicarbonate decreased	Investigations	Non-systematic Assessment	EG00043 events24 affected151 at risk EG00118 events10 affected48 at risk
Blood bilirubin increased	Investigations	Non-systematic Assessment	EG0005 events3 affected151 at risk EG0015 events3 affected48 at risk
Blood calcium decreased	Investigations	Non-systematic Assessment	EG00010 events9 affected151 at risk EG0018 events4 affected48 at risk
Blood calcium increased	Investigations	Non-systematic Assessment	EG0005 events5 affected151 at risk EG0013 events3 affected48 at risk
Blood cholesterol increased	Investigations	Non-systematic Assessment	EG0005 events5 affected151 at risk EG0010 events0 affected48 at risk
Blood creatine phosphokinase increased	Investigations	Non-systematic Assessment	EG00037 events25 affected151 at risk EG00114 events8 affected48 at risk
Blood creatinine increased	Investigations	Non-systematic Assessment	EG00033 events19 affected151 at risk EG0016 events4 affected48 at risk
Blood glucose decreased	Investigations	Non-systematic Assessment	EG00056 events29 affected151 at risk EG00119 events11 affected48 at risk
Blood glucose increased	Investigations	Non-systematic Assessment	EG00099 events56 affected151 at risk EG00139 events21 affected48 at risk
Blood magnesium decreased	Investigations	Non-systematic Assessment	EG00031 events18 affected151 at risk EG00111 events8 affected48 at risk
Blood magnesium increased	Investigations	Non-systematic Assessment	EG0002 events2 affected151 at risk EG0010 events0 affected48 at risk
Blood phosphorus decreased	Investigations	Non-systematic Assessment	EG00038 events25 affected151 at risk EG00117 events10 affected48 at risk
Blood potassium decreased	Investigations	Non-systematic Assessment	EG00011 events8 affected151 at risk EG0011 events1 affected48 at risk
Blood potassium increased	Investigations	Non-systematic Assessment	EG0003 events3 affected151 at risk EG0010 events0 affected48 at risk
Blood pressure diastolic increased	Investigations	Non-systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected48 at risk
Blood pressure increased	Investigations	Non-systematic Assessment	EG0009 events7 affected151 at risk EG0011 events1 affected48 at risk
Blood pressure systolic increased	Investigations	Non-systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected48 at risk
Blood sodium decreased	Investigations	Non-systematic Assessment	EG0009 events8 affected151 at risk EG0011 events1 affected48 at risk
Blood sodium increased	Investigations	Non-systematic Assessment	EG00011 events8 affected151 at risk EG0013 events3 affected48 at risk
Blood triglycerides increased	Investigations	Non-systematic Assessment	EG0007 events7 affected151 at risk EG0011 events1 affected48 at risk
Body tinea	Infections and infestations	Non-systematic Assessment	EG0006 events6 affected151 at risk EG0011 events1 affected48 at risk
Bradycardia	Cardiac disorders	Non-systematic Assessment	EG0002 events1 affected151 at risk EG0010 events0 affected48 at risk
Breast cellulitis	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Breast mass	Reproductive system and breast disorders	Non-systematic Assessment	EG0002 events2 affected151 at risk EG0010 events0 affected48 at risk
Bronchitis	Infections and infestations	Non-systematic Assessment	EG0002 events2 affected151 at risk EG0010 events0 affected48 at risk
Campylobacter infection	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Carbon dioxide decreased	Investigations	Non-systematic Assessment	EG00015 events8 affected151 at risk EG0015 events3 affected48 at risk
Cartilage injury	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Cellulitis	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Cervical dysplasia	Reproductive system and breast disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0011 events1 affected48 at risk
Cervicitis	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected48 at risk
Chemical burn of skin	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Chest pain	General disorders	Non-systematic Assessment	EG0005 events5 affected151 at risk EG0010 events0 affected48 at risk
Chikungunya virus infection	Infections and infestations	Non-systematic Assessment	EG0002 events2 affected151 at risk EG0011 events1 affected48 at risk
Chills	General disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Chlamydial infection	Infections and infestations	Non-systematic Assessment	EG0002 events2 affected151 at risk EG0010 events0 affected48 at risk
Chronic gastritis	Gastrointestinal disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Complication associated with device	General disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Complication of device insertion	General disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Complication of device removal	General disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Conjunctivitis	Infections and infestations	Non-systematic Assessment	EG0008 events7 affected151 at risk EG0011 events1 affected48 at risk
Conjunctivitis allergic	Eye disorders	Non-systematic Assessment	EG0002 events2 affected151 at risk EG0010 events0 affected48 at risk
Conjunctivitis bacterial	Infections and infestations	Non-systematic Assessment	EG0002 events2 affected151 at risk EG0010 events0 affected48 at risk
Conjunctivitis viral	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Constipation	Gastrointestinal disorders	Non-systematic Assessment	EG0006 events5 affected151 at risk EG0012 events2 affected48 at risk
Contusion	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0007 events6 affected151 at risk EG0011 events1 affected48 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Cough	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0006 events6 affected151 at risk EG0010 events0 affected48 at risk
Creatinine renal clearance decreased	Investigations	Non-systematic Assessment	EG000168 events71 affected151 at risk EG00147 events21 affected48 at risk
Cutaneous sporotrichosis	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Decreased appetite	Metabolism and nutrition disorders	Non-systematic Assessment	EG0003 events3 affected151 at risk EG0011 events1 affected48 at risk
Defaecation urgency	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected48 at risk
Depressed mood	Psychiatric disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0011 events1 affected48 at risk
Depression	Psychiatric disorders	Non-systematic Assessment	EG0000 events0 affected151 at risk EG0013 events3 affected48 at risk
Dermatitis	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0003 events3 affected151 at risk EG0012 events2 affected48 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0002 events2 affected151 at risk EG0010 events0 affected48 at risk
Dermatitis atopic	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0002 events2 affected151 at risk EG0010 events0 affected48 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0005 events4 affected151 at risk EG0010 events0 affected48 at risk
Device breakage	Product Issues	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Diabetes mellitus	Metabolism and nutrition disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Diarrhoea	Gastrointestinal disorders	Non-systematic Assessment	EG00016 events13 affected151 at risk EG00110 events6 affected48 at risk
Disturbance in attention	Nervous system disorders	Non-systematic Assessment	EG0002 events2 affected151 at risk EG0012 events2 affected48 at risk
Dizziness	Nervous system disorders	Non-systematic Assessment	EG00028 events22 affected151 at risk EG0016 events5 affected48 at risk
Dry mouth	Gastrointestinal disorders	Non-systematic Assessment	EG0004 events4 affected151 at risk EG0010 events0 affected48 at risk
Dry skin	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0002 events2 affected151 at risk EG0010 events0 affected48 at risk
Dysfunctional uterine bleeding	Reproductive system and breast disorders	Non-systematic Assessment	EG0004 events4 affected151 at risk EG0012 events2 affected48 at risk
Dysgeusia	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Dysmenorrhoea	Reproductive system and breast disorders	Non-systematic Assessment	EG0003 events3 affected151 at risk EG0010 events0 affected48 at risk
Dyspareunia	Reproductive system and breast disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Dyspepsia	Gastrointestinal disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0012 events2 affected48 at risk
Dysplastic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected48 at risk
Dysuria	Renal and urinary disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Ear pain	Ear and labyrinth disorders	Non-systematic Assessment	EG0002 events2 affected151 at risk EG0014 events3 affected48 at risk
Eczema	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0002 events2 affected151 at risk EG0010 events0 affected48 at risk
Electrocardiogram PR prolongation	Investigations	Non-systematic Assessment	EG0004 events3 affected151 at risk EG0011 events1 affected48 at risk
Electrocardiogram QT prolonged	Investigations	Non-systematic Assessment	EG00013 events7 affected151 at risk EG0014 events3 affected48 at risk
Electrocardiogram T wave inversion	Investigations	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0012 events1 affected48 at risk
Electrocardiogram repolarisation abnormality	Investigations	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0011 events1 affected48 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0002 events2 affected151 at risk EG0010 events0 affected48 at risk
Erythema	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0002 events2 affected151 at risk EG0013 events2 affected48 at risk
Escherichia urinary tract infection	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Essential hypertension	Vascular disorders	Non-systematic Assessment	EG0003 events1 affected151 at risk EG0010 events0 affected48 at risk
Exostosis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected48 at risk
Exposure to toxic agent	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
External ear inflammation	Ear and labyrinth disorders	Non-systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected48 at risk
Eye injury	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Eye irritation	Eye disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Eye pruritus	Eye disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Facial paralysis	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Faeces soft	Gastrointestinal disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Fatigue	General disorders	Non-systematic Assessment	EG00015 events11 affected151 at risk EG0017 events6 affected48 at risk
Feeling hot	General disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Feeling jittery	General disorders	Non-systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected48 at risk
Femoroacetabular impingement	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Flatulence	Gastrointestinal disorders	Non-systematic Assessment	EG0002 events2 affected151 at risk EG0011 events1 affected48 at risk
Food poisoning	Gastrointestinal disorders	Non-systematic Assessment	EG0004 events4 affected151 at risk EG0010 events0 affected48 at risk
Fungal infection	Infections and infestations	Non-systematic Assessment	EG0002 events2 affected151 at risk EG0010 events0 affected48 at risk
Fungal skin infection	Infections and infestations	Non-systematic Assessment	EG0002 events2 affected151 at risk EG0010 events0 affected48 at risk
Furuncle	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected48 at risk
Gastritis	Gastrointestinal disorders	Non-systematic Assessment	EG0005 events5 affected151 at risk EG0010 events0 affected48 at risk
Gastroenteritis	Infections and infestations	Non-systematic Assessment	EG0005 events4 affected151 at risk EG0012 events2 affected48 at risk
Gastroenteritis viral	Infections and infestations	Non-systematic Assessment	EG0006 events6 affected151 at risk EG0011 events1 affected48 at risk
Gastrointestinal infection	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected48 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	Non-systematic Assessment	EG0003 events3 affected151 at risk EG0010 events0 affected48 at risk
Genital candidiasis	Infections and infestations	Non-systematic Assessment	EG0003 events2 affected151 at risk EG0010 events0 affected48 at risk
Genital herpes	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Genital infection fungal	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Genitourinary tract gonococcal infection	Infections and infestations	Non-systematic Assessment	EG0002 events2 affected151 at risk EG0010 events0 affected48 at risk
Gingivitis	Infections and infestations	Non-systematic Assessment	EG0003 events3 affected151 at risk EG0011 events1 affected48 at risk
Groin abscess	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Haematochezia	Gastrointestinal disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Haemoglobin decreased	Investigations	Non-systematic Assessment	EG00011 events6 affected151 at risk EG0013 events1 affected48 at risk
Haemorrhoids	Gastrointestinal disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Headache	Nervous system disorders	Non-systematic Assessment	EG00078 events53 affected151 at risk EG00113 events11 affected48 at risk
Heart rate increased	Investigations	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Heat illness	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected48 at risk
Herpes zoster	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected48 at risk
Hordeolum	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Human bite	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Hunger	General disorders	Non-systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected48 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected48 at risk
Hyperglycaemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0004 events4 affected151 at risk EG0013 events3 affected48 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0002 events2 affected151 at risk EG0010 events0 affected48 at risk
Hypernatraemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0002 events2 affected151 at risk EG0012 events2 affected48 at risk
Hyperphagia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Hypersensitivity	Immune system disorders	Non-systematic Assessment	EG0003 events3 affected151 at risk EG0011 events1 affected48 at risk
Hypersomnia	Nervous system disorders	Non-systematic Assessment	EG0002 events2 affected151 at risk EG0010 events0 affected48 at risk
Hypertension	Vascular disorders	Non-systematic Assessment	EG0008 events8 affected151 at risk EG0010 events0 affected48 at risk
Hypoaesthesia	Nervous system disorders	Non-systematic Assessment	EG00010 events7 affected151 at risk EG0011 events1 affected48 at risk
Hypobarism	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected48 at risk
Hypocalcaemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Hypochromic anaemia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Hypoglycaemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG00012 events7 affected151 at risk EG0012 events1 affected48 at risk
Hypokalaemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0003 events2 affected151 at risk EG0013 events1 affected48 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0002 events1 affected151 at risk EG0010 events0 affected48 at risk
Hyponatraemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 events0 affected151 at risk EG0012 events2 affected48 at risk
Hypophosphataemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0008 events6 affected151 at risk EG0012 events1 affected48 at risk
Implant site pain	General disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Increased appetite	Metabolism and nutrition disorders	Non-systematic Assessment	EG0003 events3 affected151 at risk EG0011 events1 affected48 at risk
Induration	General disorders	Non-systematic Assessment	EG0002 events2 affected151 at risk EG0010 events0 affected48 at risk
Infected bite	Infections and infestations	Non-systematic Assessment	EG0002 events2 affected151 at risk EG0010 events0 affected48 at risk
Infection parasitic	Infections and infestations	Non-systematic Assessment	EG0002 events2 affected151 at risk EG0010 events0 affected48 at risk
Inflammation	General disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Influenza	Infections and infestations	Non-systematic Assessment	EG00011 events10 affected151 at risk EG0015 events4 affected48 at risk
Influenza like illness	General disorders	Non-systematic Assessment	EG00019 events15 affected151 at risk EG0011 events1 affected48 at risk
Initial insomnia	Psychiatric disorders	Non-systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected48 at risk
Injection related reaction	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Injection site bruising	General disorders	Non-systematic Assessment	EG00023 events19 affected151 at risk EG0012 events2 affected48 at risk
Injection site dermatitis	General disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Injection site discomfort	General disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Injection site erythema	General disorders	Non-systematic Assessment	EG00016 events10 affected151 at risk EG0010 events0 affected48 at risk
Injection site induration	General disorders	Non-systematic Assessment	EG00039 events24 affected151 at risk EG0012 events1 affected48 at risk
Injection site nodule	General disorders	Non-systematic Assessment	EG0009 events7 affected151 at risk EG0010 events0 affected48 at risk
Injection site pain	General disorders	Non-systematic Assessment	EG000567 events120 affected151 at risk EG00129 events11 affected48 at risk
Injection site pruritus	General disorders	Non-systematic Assessment	EG0006 events4 affected151 at risk EG0010 events0 affected48 at risk
Injection site reaction	General disorders	Non-systematic Assessment	EG0005 events4 affected151 at risk EG0010 events0 affected48 at risk
Injection site swelling	General disorders	Non-systematic Assessment	EG00017 events11 affected151 at risk EG0010 events0 affected48 at risk
Injection site warmth	General disorders	Non-systematic Assessment	EG0004 events3 affected151 at risk EG0010 events0 affected48 at risk
Injury	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected48 at risk
Insomnia	Psychiatric disorders	Non-systematic Assessment	EG00018 events13 affected151 at risk EG0012 events2 affected48 at risk
Intertrigo	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Intracranial pressure increased	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Iron deficiency	Metabolism and nutrition disorders	Non-systematic Assessment	EG0004 events3 affected151 at risk EG0010 events0 affected48 at risk
Irritability	Psychiatric disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Joint dislocation	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Joint injury	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0002 events2 affected151 at risk EG0012 events2 affected48 at risk
Joint stiffness	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0003 events1 affected151 at risk EG0010 events0 affected48 at risk
Laceration	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0011 events1 affected48 at risk
Laryngitis bacterial	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Libido decreased	Psychiatric disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Ligament laxity	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Ligament sprain	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0003 events3 affected151 at risk EG0011 events1 affected48 at risk
Limb injury	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0003 events3 affected151 at risk EG0010 events0 affected48 at risk
Lipase increased	Investigations	Non-systematic Assessment	EG00034 events23 affected151 at risk EG00126 events14 affected48 at risk
Low density lipoprotein increased	Investigations	Non-systematic Assessment	EG0009 events9 affected151 at risk EG0012 events2 affected48 at risk
Lower respiratory tract infection	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Lumbar radiculopathy	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected48 at risk
Lymphocyte count decreased	Investigations	Non-systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected48 at risk
Lymphopenia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Malaise	General disorders	Non-systematic Assessment	EG0002 events2 affected151 at risk EG0010 events0 affected48 at risk
Malaria	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected48 at risk
Mastoiditis	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Menorrhagia	Reproductive system and breast disorders	Non-systematic Assessment	EG0003 events2 affected151 at risk EG0010 events0 affected48 at risk
Metabolic syndrome	Metabolism and nutrition disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Metrorrhagia	Reproductive system and breast disorders	Non-systematic Assessment	EG0002 events1 affected151 at risk EG0010 events0 affected48 at risk
Migraine	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0011 events1 affected48 at risk
Molluscum contagiosum	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Mood altered	Psychiatric disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Mood swings	Psychiatric disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Motion sickness	Ear and labyrinth disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Mouth ulceration	Gastrointestinal disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Muscle strain	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0002 events2 affected151 at risk EG0012 events2 affected48 at risk
Muscle tightness	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Muscle twitching	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0012 events1 affected48 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected48 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0002 events1 affected151 at risk EG0010 events0 affected48 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG00014 events13 affected151 at risk EG0015 events4 affected48 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Myalgia	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG00019 events16 affected151 at risk EG0017 events4 affected48 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0008 events8 affected151 at risk EG0014 events4 affected48 at risk
Nasal inflammation	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected151 at risk EG0012 events1 affected48 at risk
Nasal polyps	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Nasopharyngitis	Infections and infestations	Non-systematic Assessment	EG0008 events8 affected151 at risk EG0017 events4 affected48 at risk
Nausea	Gastrointestinal disorders	Non-systematic Assessment	EG00023 events18 affected151 at risk EG0017 events5 affected48 at risk
Neck pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0008 events8 affected151 at risk EG0010 events0 affected48 at risk
Nerve compression	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Neutrophil count decreased	Investigations	Non-systematic Assessment	EG0003 events2 affected151 at risk EG0012 events1 affected48 at risk
Night blindness	Eye disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Oedema peripheral	General disorders	Non-systematic Assessment	EG0003 events3 affected151 at risk EG0010 events0 affected48 at risk
Oligomenorrhoea	Reproductive system and breast disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Oral herpes	Infections and infestations	Non-systematic Assessment	EG0002 events2 affected151 at risk EG0011 events1 affected48 at risk
Oropharyngeal gonococcal infection	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0005 events5 affected151 at risk EG0011 events1 affected48 at risk
Orthostatic hypotension	Vascular disorders	Non-systematic Assessment	EG0002 events2 affected151 at risk EG0010 events0 affected48 at risk
Otitis externa	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Otitis media bacterial	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected48 at risk
Ovarian cyst	Reproductive system and breast disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Pain	General disorders	Non-systematic Assessment	EG0002 events2 affected151 at risk EG0011 events1 affected48 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG00010 events10 affected151 at risk EG0012 events2 affected48 at risk
Papule	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0002 events2 affected151 at risk EG0011 events1 affected48 at risk
Paraesthesia	Nervous system disorders	Non-systematic Assessment	EG0009 events7 affected151 at risk EG0011 events1 affected48 at risk
Paraesthesia oral	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected151 at risk EG0012 events2 affected48 at risk
Paronychia	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected48 at risk
Patellofemoral pain syndrome	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected48 at risk
Pelvic inflammatory disease	Infections and infestations	Non-systematic Assessment	EG0002 events2 affected151 at risk EG0010 events0 affected48 at risk
Penile ulceration	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Periorbital cellulitis	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Pharyngeal erythema	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Pharyngeal exudate	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Pharyngitis	Infections and infestations	Non-systematic Assessment	EG0002 events2 affected151 at risk EG0010 events0 affected48 at risk
Pharyngitis bacterial	Infections and infestations	Non-systematic Assessment	EG0004 events3 affected151 at risk EG0010 events0 affected48 at risk
Photophobia	Eye disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Photosensitivity reaction	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Plantar fasciitis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Platelet count decreased	Investigations	Non-systematic Assessment	EG0003 events3 affected151 at risk EG0011 events1 affected48 at risk
Pneumonia bacterial	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected48 at risk
Polydipsia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Polyuria	Renal and urinary disorders	Non-systematic Assessment	EG0002 events2 affected151 at risk EG0010 events0 affected48 at risk
Post lumbar puncture syndrome	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Post procedural contusion	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected48 at risk
Post procedural infection	Infections and infestations	Non-systematic Assessment	EG0002 events1 affected151 at risk EG0010 events0 affected48 at risk
Post procedural swelling	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Postoperative wound infection	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Presyncope	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Procedural headache	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected48 at risk
Procedural pain	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0004 events4 affected151 at risk EG0010 events0 affected48 at risk
Proctitis chlamydial	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Protein urine	Investigations	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Proteinuria	Renal and urinary disorders	Non-systematic Assessment	EG0005 events5 affected151 at risk EG0010 events0 affected48 at risk
Pruritus	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0004 events4 affected151 at risk EG0011 events1 affected48 at risk
Pruritus generalised	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0004 events3 affected151 at risk EG0010 events0 affected48 at risk
Pseudopapilloedema	Eye disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Puncture site pain	General disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Pyelonephritis	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Pyrexia	General disorders	Non-systematic Assessment	EG00010 events9 affected151 at risk EG0010 events0 affected48 at risk
Radius fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Rash	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0004 events4 affected151 at risk EG0011 events1 affected48 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 events0 affected151 at risk EG0012 events1 affected48 at risk
Rash macular	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0003 events3 affected151 at risk EG0010 events0 affected48 at risk
Rash papular	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0003 events3 affected151 at risk EG0010 events0 affected48 at risk
Rhinitis	Infections and infestations	Non-systematic Assessment	EG0003 events3 affected151 at risk EG0012 events2 affected48 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0005 events4 affected151 at risk EG0011 events1 affected48 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0002 events2 affected151 at risk EG0010 events0 affected48 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Schistosomiasis	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Seasonal allergy	Immune system disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0011 events1 affected48 at risk
Seborrhoea	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Seizure	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Sinus arrhythmia	Cardiac disorders	Non-systematic Assessment	EG0003 events3 affected151 at risk EG0011 events1 affected48 at risk
Sinus bradycardia	Cardiac disorders	Non-systematic Assessment	EG0002 events2 affected151 at risk EG0011 events1 affected48 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Sinus pain	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0002 events2 affected151 at risk EG0010 events0 affected48 at risk
Sinusitis	Infections and infestations	Non-systematic Assessment	EG0006 events5 affected151 at risk EG0011 events1 affected48 at risk
Sinusitis bacterial	Infections and infestations	Non-systematic Assessment	EG0002 events2 affected151 at risk EG0011 events1 affected48 at risk
Skin abrasion	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0004 events2 affected151 at risk EG0010 events0 affected48 at risk
Skin erosion	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Skin odour abnormal	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Sleep disorder	Psychiatric disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0011 events1 affected48 at risk
Sneezing	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0011 events1 affected48 at risk
Soft tissue injury	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0002 events1 affected151 at risk EG0010 events0 affected48 at risk
Somnolence	Nervous system disorders	Non-systematic Assessment	EG0003 events3 affected151 at risk EG0011 events1 affected48 at risk
Spinal cord compression	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Spondylitis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected48 at risk
Stress	Psychiatric disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Subcutaneous abscess	Infections and infestations	Non-systematic Assessment	EG0002 events2 affected151 at risk EG0010 events0 affected48 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected48 at risk
Synovitis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected48 at risk
Tachycardia	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected151 at risk EG0012 events1 affected48 at risk
Tendon injury	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Tendon pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected48 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0002 events2 affected151 at risk EG0010 events0 affected48 at risk
Tenosynovitis stenosans	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Tension headache	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0011 events1 affected48 at risk
Testicular swelling	Reproductive system and breast disorders	Non-systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected48 at risk
Thirst	General disorders	Non-systematic Assessment	EG0002 events1 affected151 at risk EG0011 events1 affected48 at risk
Throat irritation	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Tinea cruris	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Tinea infection	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0011 events1 affected48 at risk
Tinea versicolour	Infections and infestations	Non-systematic Assessment	EG0002 events2 affected151 at risk EG0010 events0 affected48 at risk
Tongue coated	Gastrointestinal disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Tonsillitis	Infections and infestations	Non-systematic Assessment	EG0003 events3 affected151 at risk EG0011 events1 affected48 at risk
Tonsillitis bacterial	Infections and infestations	Non-systematic Assessment	EG0004 events4 affected151 at risk EG0011 events1 affected48 at risk
Tooth abscess	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Tooth fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Tooth impacted	Gastrointestinal disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Toothache	Gastrointestinal disorders	Non-systematic Assessment	EG0003 events3 affected151 at risk EG0010 events0 affected48 at risk
Torticollis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Tremor	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Trichoglossia	Gastrointestinal disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Umbilical hernia	Gastrointestinal disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Upper respiratory tract infection	Infections and infestations	Non-systematic Assessment	EG00041 events25 affected151 at risk EG00113 events11 affected48 at risk
Upper respiratory tract infection bacterial	Infections and infestations	Non-systematic Assessment	EG00013 events10 affected151 at risk EG0011 events1 affected48 at risk
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected48 at risk
Urethritis gonococcal	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Urinary hesitation	Renal and urinary disorders	Non-systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected48 at risk
Urinary incontinence	Renal and urinary disorders	Non-systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected48 at risk
Urinary tract infection	Infections and infestations	Non-systematic Assessment	EG00011 events9 affected151 at risk EG0012 events2 affected48 at risk
Urinary tract infection bacterial	Infections and infestations	Non-systematic Assessment	EG0009 events7 affected151 at risk EG0011 events1 affected48 at risk
Urticaria	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0008 events4 affected151 at risk EG0012 events2 affected48 at risk
Urticaria papular	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0002 events2 affected151 at risk EG0010 events0 affected48 at risk
Uterine haemorrhage	Reproductive system and breast disorders	Non-systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected48 at risk
Vaginal discharge	Reproductive system and breast disorders	Non-systematic Assessment	EG0005 events5 affected151 at risk EG0010 events0 affected48 at risk
Vertigo	Ear and labyrinth disorders	Non-systematic Assessment	EG0002 events2 affected151 at risk EG0010 events0 affected48 at risk
Vessel puncture site haematoma	General disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Vessel puncture site pain	General disorders	Non-systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected48 at risk
Viral infection	Infections and infestations	Non-systematic Assessment	EG0005 events5 affected151 at risk EG0013 events2 affected48 at risk
Viral pharyngitis	Infections and infestations	Non-systematic Assessment	EG0005 events5 affected151 at risk EG0010 events0 affected48 at risk
Viral rhinitis	Infections and infestations	Non-systematic Assessment	EG0009 events6 affected151 at risk EG0010 events0 affected48 at risk
Viral tonsillitis	Infections and infestations	Non-systematic Assessment	EG0002 events1 affected151 at risk EG0010 events0 affected48 at risk
Viral upper respiratory tract infection	Infections and infestations	Non-systematic Assessment	EG00018 events16 affected151 at risk EG00110 events8 affected48 at risk
Vision blurred	Eye disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Visual impairment	Eye disorders	Non-systematic Assessment	EG0000 events0 affected151 at risk EG0012 events2 affected48 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	Non-systematic Assessment	EG0002 events2 affected151 at risk EG0010 events0 affected48 at risk
Vomiting	Gastrointestinal disorders	Non-systematic Assessment	EG00014 events9 affected151 at risk EG0013 events2 affected48 at risk
Vomiting in pregnancy	Pregnancy, puerperium and perinatal conditions	Non-systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected48 at risk
Vulvovaginal candidiasis	Infections and infestations	Non-systematic Assessment	EG0006 events6 affected151 at risk EG0012 events1 affected48 at risk
Vulvovaginal mycotic infection	Infections and infestations	Non-systematic Assessment	EG0004 events3 affected151 at risk EG0010 events0 affected48 at risk
Vulvovaginal pruritus	Reproductive system and breast disorders	Non-systematic Assessment	EG0002 events2 affected151 at risk EG0010 events0 affected48 at risk
Vulvovaginitis	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected48 at risk
Weight decreased	Investigations	Non-systematic Assessment	EG0004 events2 affected151 at risk EG0014 events3 affected48 at risk
White blood cell count decreased	Investigations	Non-systematic Assessment	EG0002 events2 affected151 at risk EG0010 events0 affected48 at risk
Xerosis	General disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Zika virus infection	Infections and infestations	Non-systematic Assessment	EG0002 events2 affected151 at risk EG0011 events1 affected48 at risk

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral
D012749	Sexually Transmitted Diseases
D016180	Lentivirus Infections
D012192	Retroviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D007153	Immunologic Deficiency Syndromes
D007154	Immune System Diseases

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Group 1: GSK1265744	Participants in Cohorts 1 and 2 will receive one GSK1265744 tablet orally every day from study entry through Week 4. They will then receive an injection of GSK1265744-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2. GSK1265744 Tablets: 30-mg tablets, taken orally Injectable GSK1265744: Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections Cohort 2: 600-mg injection, administered as one IM gluteal injection	0	151	4	151	147	151
EG001	Group 2: Placebo	Participants in Cohorts 1 and 2 will receive one placebo tablet orally every day from study entry through Week 4. They will then receive an injection of placebo-at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2. Placebo for GSK1265744 Tablets: Taken orally Injectable Placebo for GSK1265744: Cohort 1: Sodium Chloride for Injection USP, 0.9%; administered as two 400-mg IM gluteal injections Cohort 2: Sodium Chloride for Injection USP, 0.9%; administered as one 600-mg IM gluteal injection	0	48	2	48	48	48

Term	Organ System	Assessment Type	Statistical Information
Vertigo positional	Ear and labyrinth disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Acute kidney injury	Renal and urinary disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Sensory loss	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk
Cholelithiasis	Hepatobiliary disorders	Non-systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected48 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	Non-systematic Assessment	EG0000 events0 affected151 at risk EG0011 events1 affected48 at risk
Laryngitis bacterial	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected151 at risk EG0010 events0 affected48 at risk