Trial Outcomes & Findings for Study to Explore the Effect of Mefloquine in Participants With Progressive Multifocal Leukoencephalopathy (PML) (NCT NCT00746941)

NCT ID: NCT00746941

Last Updated: 2014-07-31

Results Overview

Change from baseline to Week 4 in JC viral load in CSF is expressed as log10 copies/mL. Negative values indicate a reduction in viral load. Only participants with measurable baseline values are included. Post-baseline values of 'Below the Limit of Quantification' or 'Below Limit of Detection' or 'Negative' were set to 50. Log10 (50) = 1.699

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 37 participants
• Primary outcome timeframe: Day 0 (baseline), Week 4
• Results posted on: 2014-07-31

Participant Flow

Twelve sites enrolled participants prior to study termination.

Participants were initially randomized in a 1:1 ratio to the local standard of care arm (represented below as 3 treatment arms depending on Week 4 and Week 8 decisions) or the local standard of care plus mefloquine 250 mg arm.

Participant milestones

Measure	Local Standard of Care Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital. These participants received only local standard of care throughout the study; they did not choose to add 250 mg mefloquine at Week 4 (Day 28) or Week 8 (Day 56).	Local Standard of Care; Mefloquine at Week 4 Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital. These participants chose to add 250 mg mefloquine by mouth at Week 4 for 3 days and then weekly through Week 24 to their local standard of care treatment.	Local Standard of Care; Mefloquine at Week 8 Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital. These participants chose to add 250 mg mefloquine by mouth at Week 8 for 3 days and then weekly through Week 24 to their local standard of care treatment.	Local Standard of Care Plus Mefloquine 250 mg Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
Overall Study STARTED	7	5	5	20
Overall Study COMPLETED	0	1	3	7
Overall Study NOT COMPLETED	7	4	2	13

Reasons for withdrawal

Measure	Local Standard of Care Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital. These participants received only local standard of care throughout the study; they did not choose to add 250 mg mefloquine at Week 4 (Day 28) or Week 8 (Day 56).	Local Standard of Care; Mefloquine at Week 4 Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital. These participants chose to add 250 mg mefloquine by mouth at Week 4 for 3 days and then weekly through Week 24 to their local standard of care treatment.	Local Standard of Care; Mefloquine at Week 8 Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital. These participants chose to add 250 mg mefloquine by mouth at Week 8 for 3 days and then weekly through Week 24 to their local standard of care treatment.	Local Standard of Care Plus Mefloquine 250 mg Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
Overall Study Death	2	0	0	6
Overall Study Physician Decision	0	0	2	0
Overall Study Withdrawal by Subject	3	0	0	2
Overall Study Other, reason not provided	2	4	0	4
Overall Study Adverse Event	0	0	0	1

Baseline Characteristics

Study to Explore the Effect of Mefloquine in Participants With Progressive Multifocal Leukoencephalopathy (PML)

Baseline characteristics by cohort

Measure	Local Standard of Care n=7 Participants Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital. These participants received only local standard of care throughout the study; they did not choose to add 250 mg mefloquine at Week 4 (Day 28) or Week 8 (Day 56).	Local Standard of Care; Mefloquine at Week 4 n=5 Participants Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital. These participants chose to add 250 mg mefloquine by mouth at Week 4 for 3 days and then weekly through Week 24 to their local standard of care treatment.	Local Standard of Care; Mefloquine at Week 8 n=5 Participants Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital. These participants chose to add 250 mg mefloquine by mouth at Week 8 for 3 days and then weekly through Week 24 to their local standard of care treatment.	Local Standard of Care Plus Mefloquine 250 mg n=20 Participants Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.	Total n=37 Participants Total of all reporting groups
JVC Titer at Screening <= 50 copies/mL	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	4 participants n=4 Participants	4 participants n=21 Participants
Age, Continuous	48.7 years STANDARD_DEVIATION 20.56 • n=5 Participants	41.6 years STANDARD_DEVIATION 11.37 • n=7 Participants	47.4 years STANDARD_DEVIATION 10.06 • n=5 Participants	48.1 years STANDARD_DEVIATION 9.4 • n=4 Participants	47.2 years STANDARD_DEVIATION 12.16 • n=21 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants	10 Participants n=21 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	15 Participants n=4 Participants	27 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	9 Participants n=21 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	16 Participants n=4 Participants	28 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Disease history HIV positive: HAART Naive	3 participants n=5 Participants	5 participants n=7 Participants	3 participants n=5 Participants	13 participants n=4 Participants	24 participants n=21 Participants
Disease history HIV positive: History of HAART	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	3 participants n=4 Participants	5 participants n=21 Participants
Disease history HIV negative	3 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	4 participants n=4 Participants	8 participants n=21 Participants
JVC Titer at Screening > 50 copies/mL	7 participants n=5 Participants	5 participants n=7 Participants	5 participants n=5 Participants	15 participants n=4 Participants	32 participants n=21 Participants
JVC Titer at Screening Missing	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants	1 participants n=21 Participants

PRIMARY outcome

Timeframe: Day 0 (baseline), Week 4

Population: Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms. Participants with undetectable CSF JCV load at baseline were not included in the efficacy analysis. All other enrolled participants were included in the efficacy analysis if values for Week 4 were available.

Change from baseline to Week 4 in JC viral load in CSF is expressed as log10 copies/mL. Negative values indicate a reduction in viral load.

Only participants with measurable baseline values are included. Post-baseline values of 'Below the Limit of Quantification' or 'Below Limit of Detection' or 'Negative' were set to 50. Log10 (50) = 1.699

Outcome measures

Measure	Local Standard of Care n=13 Participants Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.	Local Standard of Care Plus Mefloquine 250 mg n=14 Participants Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
Change From Baseline to Week 4 in JC Virus (JCV) Load in Cerebrospinal Fluid (CSF)	-0.2424 log10 copies/mL Standard Deviation 0.83556	-0.0675 log10 copies/mL Standard Deviation 1.52685

PRIMARY outcome

Timeframe: Day 0 (baseline), Week 8

Population: Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms. Participants with undetectable CSF JCV load at baseline were not included in the efficacy analysis. All other enrolled participants were included in the efficacy analysis if values for Week 8 were available.

Change from baseline to Week 8 in JC viral load in CSF is expressed as log10 copies/mL. Negative values indicate a reduction in viral load.

Only participants with measurable baseline values are included. Post-baseline values of 'Below the Limit of Quantification' or 'Below Limit of Detection' or 'Negative' were set to 50. Log10 (50) = 1.699

Outcome measures

Measure	Local Standard of Care n=4 Participants Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.	Local Standard of Care Plus Mefloquine 250 mg n=10 Participants Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
Change From Baseline to Week 8 in JC Virus (JCV) Load in Cerebrospinal Fluid (CSF)	-0.2843 log10 copies/mL Standard Deviation 0.68666	-0.3455 log10 copies/mL Standard Deviation 0.93960

SECONDARY outcome

Timeframe: Day 0 (baseline), Week 4 and 8

Population: Participants with values at the time frames being measured. EDSS was not required for participants who had physical or cognitive impairments that limited their ability to perform the assessment. Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms.

EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death) was calculated. Negative change scores indicate improvement.

Outcome measures

Measure	Local Standard of Care n=17 Participants Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.	Local Standard of Care Plus Mefloquine 250 mg n=30 Participants Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
Change From Baseline to Week 4 and Week 8 in the Expanded Disability Status Scale (EDSS) Score Week 4 (n=12, 21)	0.79 units on a scale Standard Deviation 1.054	0.50 units on a scale Standard Deviation 1.129
Change From Baseline to Week 4 and Week 8 in the Expanded Disability Status Scale (EDSS) Score Week 8 (n=7, 16)	0.71 units on a scale Standard Deviation 1.868	0.88 units on a scale Standard Deviation 1.360

SECONDARY outcome

Timeframe: Day 0 (baseline), Week 4, Week 8

Population: Participants with values at the time frames being measured. Participants with undetectable CSF JCV load at baseline by the central laboratory were not included in the efficacy analysis. Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms.

The KPS Index classifies participants' functional impairment. KPS can be used to compare effectiveness of different therapies and to assess the prognosis in individual participants. KPS was recorded on an 11-point scale (0, 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100.) where '0=Dead' and '100=Normal, no complaints, no evidence of disease'. The lower the KPS score, the worse the survival for most serious illnesses. The KPS index is subdivided into 3 categories: incapacitated (0 to 40), self-care (50 to 70), and normal activity (80 to 100).

Negative change from baseline scores indicate improved prognosis.

Outcome measures

Measure	Local Standard of Care n=17 Participants Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.	Local Standard of Care Plus Mefloquine 250 mg n=30 Participants Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
Change From Baseline to Week 4 and Week 8 in Karnofsky Performance Status (KPS) Index Score Week 4 (n=12, 21)	0.00 units on a scale Standard Deviation 14.771	-8.10 units on a scale Standard Deviation 12.891
Change From Baseline to Week 4 and Week 8 in Karnofsky Performance Status (KPS) Index Score Week 8 (n=7, 16)	-10.0 units on a scale Standard Deviation 26.46	-10.6 units on a scale Standard Deviation 19.14

SECONDARY outcome

Timeframe: Day 0 (baseline), Week 4, Week 8

Population: Participants with values at the time frames being measured. SDMT was not required for participants who had physical or cognitive impairments that limited their ability to perform the assessment. Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms.

The SDMT is a simple substitution task. The test gives participants 90 seconds to pair specific numbers with given geometric figures as a measure for screening cognitive impairment. The total score is the total number of correctly completed boxes in the time allowed. The test score range is from 0 (worst outcome) to 110 (best outcome).

Negative change from baseline scores indicates a worsening outcome.

Outcome measures

Measure	Local Standard of Care n=17 Participants Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.	Local Standard of Care Plus Mefloquine 250 mg n=30 Participants Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
Change From Baseline to Week 4 and Week 8 in Symbol Digit Modalities Test (SDMT) Week 4 (n=6,8)	4.00 units on a scale Standard Deviation 6.723	-1.50 units on a scale Standard Deviation 3.780
Change From Baseline to Week 4 and Week 8 in Symbol Digit Modalities Test (SDMT) Week 8 (n=3,6)	1.7 units on a scale Standard Deviation 10.12	3.8 units on a scale Standard Deviation 6.43

SECONDARY outcome

Timeframe: Day 0 (baseline), Week 4, Week 8

Population: Participants with values at the time frames being measured. VAS was not required for participants who had physical or cognitive impairments that limited their ability to perform the assessment. Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms.

Participants rate their neurological function on a scale of 100 mm line, where the 0 end of the scale indicates poor neurological function and 100 indicates excellent neurological function. VAS was not required for participants who had physical or cognitive impairments that limited their ability to perform the assessment.

Negative change from baseline scores indicates a worsening outcome.

Outcome measures

Measure	Local Standard of Care n=17 Participants Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.	Local Standard of Care Plus Mefloquine 250 mg n=30 Participants Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
Change From Baseline to Week 4 and Week 8 in Participants' Neurological Function Using a Visual Analog Scale (VAS) Week 4 (n=9,16)	8.9 units on a scale Standard Deviation 29.14	-0.7 units on a scale Standard Deviation 33.71
Change From Baseline to Week 4 and Week 8 in Participants' Neurological Function Using a Visual Analog Scale (VAS) Week 8 (n=4,13)	26.3 units on a scale Standard Deviation 49.00	3.5 units on a scale Standard Deviation 23.87

SECONDARY outcome

Timeframe: Day 0 (baseline), Week 4, Week 8

Population: Participants with values at the time frames being measured. Participants with undetectable CSF JCV load at baseline by the central laboratory were not included in the efficacy analysis. Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms.

Outcome measures

Measure	Local Standard of Care n=17 Participants Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.	Local Standard of Care Plus Mefloquine 250 mg n=30 Participants Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
Participants With Gadolinium (Gd)-Enhanced Lesions at Baseline, Week 4 and Week 8 as Seen on Magnetic Resonance Imaging (MRI) Scans of Participants' Brains Week 0 (n=15,21)	8 participants	8 participants
Participants With Gadolinium (Gd)-Enhanced Lesions at Baseline, Week 4 and Week 8 as Seen on Magnetic Resonance Imaging (MRI) Scans of Participants' Brains Week 4 (n=12,12)	5 participants	8 participants
Participants With Gadolinium (Gd)-Enhanced Lesions at Baseline, Week 4 and Week 8 as Seen on Magnetic Resonance Imaging (MRI) Scans of Participants' Brains Week 8 (n=5,11)	1 participants	7 participants

SECONDARY outcome

Timeframe: Day 0 (baseline), Week 4, Week 8

Population: Participants with values at the time frames being measured. Participants with undetectable CSF JCV load at baseline by the central laboratory were not included in the efficacy analysis. Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms.

Outcome measures

Measure	Local Standard of Care n=17 Participants Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.	Local Standard of Care Plus Mefloquine 250 mg n=30 Participants Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
Change From Baseline to Week 4 and Week 8 in T1 Lesion Volume as Seen on Magnetic Resonance Imaging (MRI) Scans of Participants' Brains Week 4 (n=12,11)	0.1407 log10 mm^3 Standard Deviation 0.20345	0.1631 log10 mm^3 Standard Deviation 0.22523
Change From Baseline to Week 4 and Week 8 in T1 Lesion Volume as Seen on Magnetic Resonance Imaging (MRI) Scans of Participants' Brains Week 8 (n=5,11)	0.0248 log10 mm^3 Standard Deviation 0.12425	0.1029 log10 mm^3 Standard Deviation 0.26502

SECONDARY outcome

Timeframe: Day 0 (baseline), Week 4, Week 8

Population: Participants with values at the time frames being measured. Participants with undetectable CSF JCV load at baseline by the central laboratory were not included in the efficacy analysis. Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms.

Outcome measures

Measure	Local Standard of Care n=17 Participants Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.	Local Standard of Care Plus Mefloquine 250 mg n=30 Participants Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
Change From Baseline to Week 4 and Week 8 in T2 Lesion Volume as Seen on Magnetic Resonance Imaging (MRI) Scans of Participants' Brains Week 4 (n=12,11)	0.1704 log10 mm^3 Standard Deviation 0.22012	0.1619 log10 mm^3 Standard Deviation 0.17501
Change From Baseline to Week 4 and Week 8 in T2 Lesion Volume as Seen on Magnetic Resonance Imaging (MRI) Scans of Participants' Brains Week 8 (n=5,10)	0.1738 log10 mm^3 Standard Deviation 0.21454	0.1050 log10 mm^3 Standard Deviation 0.23429

SECONDARY outcome

Timeframe: Day 1 up to 6 months

Population: Safety population: All participants who enrolled in the study and were dosed, and who have at least 1 post-baseline safety assessment. The death event is counted under the treatment arm relative to adding mefloquine to the treatment regimen.

The death event is counted under the treatment arm relative to adding mefloquine to the treatment regimen.

Outcome measures

Measure	Local Standard of Care n=17 Participants Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.	Local Standard of Care Plus Mefloquine 250 mg n=30 Participants Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
Participants Who Died Within 6 Months	2 participants	5 participants

Adverse Events

Local Standard of Care

Serious events: 5 serious events

Other events: 12 other events

Deaths: 0 deaths

Local Standard of Care; Mefloquine at Week 4

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Local Standard of Care; Mefloquine at Week 8

Serious events: 3 serious events

Other events: 5 other events

Deaths: 0 deaths

Local Standard of Care Plus Mefloquine 250 mg

Serious events: 13 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Measure	Local Standard of Care n=17 participants at risk Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital. Participants who chose to add mefloquine at Weeks 4 or 8 to their standard of care treatment are counted in this treatment arm until the time of switching to mefloquine treatment.	Local Standard of Care; Mefloquine at Week 4 n=5 participants at risk Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital. Participants who chose to add mefloquine at Week 4 to their standard of care treatment are counted in this treatment arm once mefloquine treatment started.	Local Standard of Care; Mefloquine at Week 8 n=5 participants at risk Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital. Participants who chose to add mefloquine at Week 8 to their standard of care treatment are counted in this treatment arm once mefloquine treatment started.	Local Standard of Care Plus Mefloquine 250 mg n=20 participants at risk Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Nervous system disorders Neurological decompensation	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Injury, poisoning and procedural complications Narcotic intoxication	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Musculoskeletal and connective tissue disorders Pain in extremity	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Infections and infestations Appendicitis	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Musculoskeletal and connective tissue disorders Muscular weakness	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
General disorders Death	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Infections and infestations Urinary tract infection	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	10.0% 2/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Infections and infestations Pneumonia	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Nervous system disorders Status epilepticus	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Infections and infestations Periorbital cellulitis	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Infections and infestations Progressive multifocal leukoencephalopathy	11.8% 2/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Infections and infestations Staphylococcal infection	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Infections and infestations Urinary tract infection pseudomonal	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Psychiatric disorders Delirium	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Infections and infestations Osteomyelitis	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Infections and infestations Meningitis	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Metabolism and nutrition disorders Marasmus	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Respiratory, thoracic and mediastinal disorders Asphyxia	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Nervous system disorders Convulsion	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	15.0% 3/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Infections and infestations Candida pneumonia	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.

Other adverse events

Measure	Local Standard of Care n=17 participants at risk Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital. Participants who chose to add mefloquine at Weeks 4 or 8 to their standard of care treatment are counted in this treatment arm until the time of switching to mefloquine treatment.	Local Standard of Care; Mefloquine at Week 4 n=5 participants at risk Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital. Participants who chose to add mefloquine at Week 4 to their standard of care treatment are counted in this treatment arm once mefloquine treatment started.	Local Standard of Care; Mefloquine at Week 8 n=5 participants at risk Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital. Participants who chose to add mefloquine at Week 8 to their standard of care treatment are counted in this treatment arm once mefloquine treatment started.	Local Standard of Care Plus Mefloquine 250 mg n=20 participants at risk Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
Nervous system disorders Apallic syndrome	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Musculoskeletal and connective tissue disorders Muscle atrophy	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Nervous system disorders Headache	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	40.0% 2/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 4/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Nervous system disorders Ataxia	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	10.0% 2/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Nervous system disorders Epilepsy	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	10.0% 2/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Nervous system disorders Hemianopia homonymous	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	10.0% 2/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Nervous system disorders Hemiparesis	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	10.0% 2/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Nervous system disorders Aphasia	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Nervous system disorders Cerebellar syndrome	11.8% 2/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Nervous system disorders Cognitive disorder	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Nervous system disorders Convulsion	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Nervous system disorders Extensor plantar response	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Nervous system disorders Hemiplegia	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Nervous system disorders Hyperreflexia	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Nervous system disorders Hypertonia	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Nervous system disorders Hypoaesthesia	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Nervous system disorders Hypokinesia	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Nervous system disorders Lethargy	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Nervous system disorders Memory impairment	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Nervous system disorders Movement disorder	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Nervous system disorders Multiple sclerosis relapse	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Nervous system disorders Muscle spasticity	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Nervous system disorders Partial seizures	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Nervous system disorders Syncope	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Nervous system disorders Visual field defect	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Nervous system disorders Disarthria	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Nervous system disorders Nervous system disorder	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Nervous system disorders Neuropathy peripheral	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Nervous system disorders Nystagmus	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Nervous system disorders Sensory loss	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Nervous system disorders Tremor	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Infections and infestations Pneumonia	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	15.0% 3/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Infections and infestations Progressive multifocal leukoencephalopathy	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	15.0% 3/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Infections and infestations Anogenital warts	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Infections and infestations Bronchitis	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Infections and infestations Campylobacter gastroenteritis	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Infections and infestations Candidiasis	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Infections and infestations Folliculitis	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Infections and infestations Genital herpes	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Infections and infestations Helicobacter gastritis	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Infections and infestations Herpes simplex	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Infections and infestations Oral candidiasis	11.8% 2/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Infections and infestations Sinusitis	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Infections and infestations Urinary tract infection	11.8% 2/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Infections and infestations Bacillus infection	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Infections and infestations Bacterial disease carrier	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Infections and infestations Cellulitis	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Infections and infestations Conjunctivitis infection	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Infections and infestations Enterobacter infection	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Infections and infestations Escherichia infection	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Infections and infestations Klebsiella infection	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Infections and infestations Oral herpes	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Infections and infestations Pelvic abscess	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Infections and infestations Purulent discharge	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Infections and infestations Pyomyositis	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Infections and infestations Rash pustular	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Infections and infestations Sepsis	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Infections and infestations Tinea versicolour	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Gastrointestinal disorders Dysphagia	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	15.0% 3/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Gastrointestinal disorders Nausea	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	15.0% 3/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Gastrointestinal disorders Constipation	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	10.0% 2/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Gastrointestinal disorders Abdominal pain	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Gastrointestinal disorders Ascites	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Gastrointestinal disorders Glossitis	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Gastrointestinal disorders Vomiting	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Gastrointestinal disorders Cheilitis	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Gastrointestinal disorders Colitis	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Gastrointestinal disorders Diarrhoea	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Gastrointestinal disorders Intestinal mucosal hypertrophy	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Gastrointestinal disorders Rectal haemorrhage	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Gastrointestinal disorders Tooth loss	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
General disorders Asthenia	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	10.0% 2/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
General disorders Pyrexia	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	10.0% 2/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
General disorders Feeling hot	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
General disorders Injection site reaction	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
General disorders Irritability	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
General disorders Local swelling	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
General disorders Mucosal membrane hyperplasia	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
General disorders Chest pain	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
General disorders Chills	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
General disorders Extravasation	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
General disorders Gait disturbance	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
General disorders Infusion site haematoma	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
General disorders Oedema peripheral	11.8% 2/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	40.0% 2/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Psychiatric disorders Anxiety	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	10.0% 2/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Psychiatric disorders Abnormal behaviour	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Psychiatric disorders Confusional state	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Psychiatric disorders Depression	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Psychiatric disorders Insomnia	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Psychiatric disorders Sleep disorder	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Psychiatric disorders Abnormal dreams	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Psychiatric disorders Agitation	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Psychiatric disorders Delusion	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Psychiatric disorders Drug abuse	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Psychiatric disorders Drug dependence	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Psychiatric disorders Dysphemia	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Psychiatric disorders Hallucination, auditory	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	10.0% 2/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Metabolism and nutrition disorders Dehydration	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Metabolism and nutrition disorders Magnesium deficiency	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Metabolism and nutrition disorders Hyperlipidaemia	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	10.0% 2/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Musculoskeletal and connective tissue disorders Mobility decreased	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Musculoskeletal and connective tissue disorders Arthralgia	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Musculoskeletal and connective tissue disorders Coccydynia	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Musculoskeletal and connective tissue disorders Joint swelling	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Musculoskeletal and connective tissue disorders Musculoskeletal disorder	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Ear and labyrinth disorders Vertigo	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	10.0% 2/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Ear and labyrinth disorders Ear pain	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Ear and labyrinth disorders Otorrhoea	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Eye disorders Diplopia	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Eye disorders Iridocyclitis	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Eye disorders Scotoma	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Eye disorders Visual impairment	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Eye disorders Eye discharge	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Eye disorders Eye irritation	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Eye disorders Eye pain	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Eye disorders Inflammation of lacrimal passage	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Eye disorders Periorbital oedema	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Eye disorders Photopsia	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Eye disorders Vision blurred	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Injury, poisoning and procedural complications Contusion	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	10.0% 2/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Injury, poisoning and procedural complications Limb injury	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Injury, poisoning and procedural complications Excoriation	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Injury, poisoning and procedural complications Fall	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Injury, poisoning and procedural complications Fracture displacement	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Injury, poisoning and procedural complications Head injury	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Injury, poisoning and procedural complications Mouth injury	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Investigations Aspartate aminotransferase increased	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Investigations Blood lactate dehydrogenase increased	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Investigations Liver function test abnormal	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Investigations Skin turgor decreased	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Investigations Weight decreased	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Investigations Blood bicarbonate decreased	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Investigations Blood bilirubin increased	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Investigations Blood glucose increased	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Investigations Blood potassium decreased	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Investigations Blood potassium increased	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Investigations Blood pressure increased	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Investigations Breath sounds abnormal	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	40.0% 2/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Investigations Eosinophil count increased	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Investigations Haematocrit decreased	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Investigations Haemoglobin decreased	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Investigations Neurological examination abnormal	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Investigations Prealbumin decreased	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Investigations Red blood cell count decreased	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Investigations Vitamin D decreased	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Investigations White blood cell count decreased	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Renal and urinary disorders Pollakiuria	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Renal and urinary disorders Renal failure	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Renal and urinary disorders Urinary incontinence	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Renal and urinary disorders Micturition urgency	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Renal and urinary disorders Urinary retention	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Vascular disorders Hypertension	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Vascular disorders Hypotension	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Vascular disorders Phlebitis	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Vascular disorders Deep vein thrombosis	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Vascular disorders Phlebolith	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Blood and lymphatic system disorders Anaemia	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Blood and lymphatic system disorders Hilar lymphaedenopathy	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Blood and lymphatic system disorders Neutropenia	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Blood and lymphatic system disorders Splenomegaly	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Cardiac disorders Arrhythmia supraventricular	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Cardiac disorders Tachycardia	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Cardiac disorders Dilatation ventricular	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Cardiac disorders Sinus arrhythmia	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Cardiac disorders Sinus bradycardia	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Cardiac disorders Sinus tachycardia	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Skin and subcutaneous tissue disorders Blister	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Skin and subcutaneous tissue disorders Decubitus ulcer	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Skin and subcutaneous tissue disorders Dennie-Morgan fold	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Skin and subcutaneous tissue disorders Dry skin	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	40.0% 2/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Skin and subcutaneous tissue disorders Exfoliative rash	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Skin and subcutaneous tissue disorders Petechiae	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Skin and subcutaneous tissue disorders Pruritus	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Skin and subcutaneous tissue disorders Rash	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Skin and subcutaneous tissue disorders Skin hypertrophy	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Skin and subcutaneous tissue disorders Skin ulcer	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Immune system disorders Immune reconstitution syndrome	11.8% 2/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	5.0% 1/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Respiratory, thoracic and mediastinal disorders Acquired diaphragmatic eventration	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Respiratory, thoracic and mediastinal disorders Aspiration	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Respiratory, thoracic and mediastinal disorders Hypoventilation	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Respiratory, thoracic and mediastinal disorders Hypoxia	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Respiratory, thoracic and mediastinal disorders Pleural effusion	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Respiratory, thoracic and mediastinal disorders Pneumonitis	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Respiratory, thoracic and mediastinal disorders Respiratory distress	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Respiratory, thoracic and mediastinal disorders Tachypnoea	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Respiratory, thoracic and mediastinal disorders Tonsillar hypertrophy	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Reproductive system and breast disorders Cervical dysplasia	0.00% 0/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	20.0% 1/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.
Reproductive system and breast disorders Vaginal discharge	5.9% 1/17 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/5 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.	0.00% 0/20 • Day 1 to Month 6 Because participants were primarily patients with HIV/Acquired Immunodeficiency Syndrome (AIDS), SAEs considered to be AIDS-Defining Events (ADEs) were exempt from SAE reporting and were collected on a specific case report form instead of being captured as SAEs. However, any ADE that resulted in death did not qualify for an SAE exemption.

Additional Information

Biogen Idec Study Medical Director

Biogen Idec

Email: clinicaltrials@biogenidec.com

Results disclosure agreements

• Principal investigator is a sponsor employee The PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 45 to 60 days as agreed within their clinical trial agreement to review any manuscript for a proposed publication and must delay publication for up to an additional 60 to 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
• Publication restrictions are in place

Restriction type: OTHER